Welcome to the Dr. Gabrielle Lyon show where cutting edge science meets innovation and practical application for everybody. In today’s episode, I sit down with the metabolic CEO, Sha Lin Sha. He’s the CEO for Marius Pharmaceuticals and he’s brought the FDA approved drug, Kaiser-Trex, which is oral testosterone to market. In this episode, we sit down and we learn all about testosterone, where testosterone has come from, where it is in the present space in the pharmaceutical industry, and so much more. Please join me in sitting down with Sha Lin Sha. This episode has been supported by Marius Pharmaceuticals. 

Shalin Shah, welcome to the podcast. 

Thank you for having me. 

I’m actually really, really excited to have this conversation. I want to give you a little bit of a backstory, which I don’t know if you know this. So you are the CEO of Marius Pharmaceuticals, which by the way has been instrumental in the development and FDA approval of something called Kaiser-Trex, 

which is oral testosterone. 

Yep. 

Okay. So let’s talk about, let’s just give the listeners a little bit of a background. My husband is, so he was a former Navy SEAL who is now in his second year of urology residency, happens to be a Baylor, which is one of the number one places that one would be able to study andrology, specifically testosterone and other anabolic, who works underneath Dr. Mohakkara, 

who by the way is a very good friend of yours and who’s also doing some of the really pivotal research in… 

Yep. Mohakkara is a close advisor and friend and has really been helpful in bringing light to obviously the therapy and Kaiser-Trex itself. 

Which is amazing. And I said, from my perspective as someone who sees patients, I was always thinking that really the most effective route and understanding of testosterone would be injectable. 

Yep.

And there were various challenges that I was having with some of my patients, like for example, when you inject testosterone, you might see a quick elevation in hematocrit. Right? And for the listener, for the other physicians listening, there might be a risk of, I mean, whether it is a perceived risk or a relative risk, it is still within the guidelines that you would need to really monitor hematocrit and treat it specifically. Which brings me to when I called him, I said, “Okay, Mo, what are my options?” 

And I had never heard about Kaiser-Trex before or any form of oral, which I assume, from what I understand, there are three oral testosterone. Yep. So that was a very long winded way of welcoming you to the podcast and I’m so excited to learn. You’ve really been doing some very instrumental work. 

No, I appreciate that. And again, super glad to be here. I think there’s a lot that the general population needs to know. Testosterone has a very, it’s a very misunderstood molecule, to be honest, right? And I think it’s very important for patients and prospective patients to understand what it does, what its role is, and then, yes, what the options are, what’s going to fit them. But we are really excited about Kaiser-Trex because I think not only oral has solved an administration pain, quite literally a pain that’s been out there, but the efficacy and safety data that we continue to unfold, I think, make it more and more compelling that this will be the standard of care. 

Can you tell me a little bit about, well, you know, I’m curious as to how you got involved in this. Sure. I do think that there is something really important in the conversation of being able to separate, quote, “big pharma” and pharmaceutical interventions like testosterone therapy. 

Sure. So I have an investment background. I’ve been doing that all my career. And you did your undergrad at Rutgers, by the way. 

Yep. Small world. Exactly. So also a Northeast, I guess, resident in that sense. 

But, yeah, so I’ve had this background and we’ve generally looked at, let’s call it, underappreciated assets and finding value within them. So Kaiser-Trex was in development since 2009, and this all happened in the RTP area, and that’s where Marius is headquartered.

So great data. You know, the formulation that it developed was very unique. It actually used something called phytosterols, which plant sterols are often used as supplement products for heart health and so forth. So that’s really how they crack the code on oral, because oral, again, was notoriously hard to develop. Going back to very early days, it was always liver toxic. So they had to find a way that it was lymphatically absorbed, which, again, that’s through the small intestine. Right. 

And when was the first? The first oral testosterone was how long ago? 

So actually, interestingly enough, the first oral testosterone is when they actually isolated testosterone in 1935. So it was almost 100 years that that was the original conception of testosterone, but it was liver toxic. 

It was liver toxic. 

So that just wouldn’t work, right? And that’s why they moved to injectables. And if you look at the timeline, then injectables morphed into testosterone, CPN, and enanti in the fifties. 

And then it wasn’t until the 1970s or so there actually was oral testosterone that was developed that was not liver toxic. The issue there was that it was requiring dosing three, four or five times a day with fatty meals, right, for absorption because the half-life was so, so short. But it actually got approval in pretty much everywhere around the world, except the United States. So the U.S. is the only place that didn’t have this tool available. And this was in the 70s. So fast forward another 40 years almost. 

Do you got was there a reason why it wasn’t approved? 

So I think, you know, again, FDA, while is the gold standard across most of the world, I think there are, you know, issues at the agency. And happy to dive into that later specifically, because I think this therapy has been frankly mistreated by the FDA and patients are the ones suffering. 

But again, so I don’t think there’s a real rhyme or reason why it wasn’t here. I think, you know, you can probably find the same for a few drugs across the spectrum. 

But then again, it was 40 years or so till then an oral testosterone that really cracked the code of, you know, yes, it’s BID dosing. Which is twice a day. Twice a day, yes, twice a day.

But the food effect has changed drastically. So you don’t, for Kaiser trucks, for example, you don’t need to have a super fatty meal. You need to take it with food, but you don’t have to have that 30, 40, 50 grams of fat, which most people would never have for a meal. Right. So that’s that’s again, that’s fast forward to today. Now you have that tool in the toolbox that I think really, again, it changes the paradigm for where I think testosterone therapy can go. 

Where do you think it is in when you think about the understanding for the general population? Where do you think their perception is versus what potential realities are for, 

you know, we hear a lot of things that are actually Dr. Mo, Dr. Mo, Kara has really dispelled, for example, testosterone will cause issues, cardiovascular issues. We know that that is not true. 

There is potentially a role of low testosterone in various different problems like metabolic syndrome. 

The list goes on osteoporosis, depression. 

But from your perspective, as someone who is really trying to bring Kaiser trucks and just testosterone in general to the mainstream, where do you think the barriers are? 

So the understanding, I think if you will get, you know, look at the whole pie, right? I think if you look at half the folks out there, they don’t know anything about testosterone at all. So even even the male population understanding that it’s a vital hormone to them. I think 50 percent of the population is unaware of it. I think 40 percent of the population still carries these misconceptions, whether it is the cardiovascular risk, the prostate cancer. I mean, even urologists and cardiologists still have hold on to some of these notions, whether they were frankly trained a long time ago or having kept up or again, we just get rooted in these notions. I think that is 40 percent of the people. And then maybe 10 percent, I think, actually understand. And those are, you know, maybe a lot of the folks that listen to your show or see, you know, great physicians like yourself to help not just, you know, feel better and live a better health span, but really want to improve their underlying metabolic health. I think that’s 10 percent today, maximum.

Why do you think that there are such huge barriers? Do you think it’s an education? It’s absolutely an education issue. 

Again, you have to like testosterone has been around for almost 100 years and you just have these periods where I think the public and the medical community have been, I don’t want to say scared, but but 

definitely scared. Even as providers, I would say that if you are not in andrology, which is again the study of or in part the study of sex hormones, especially testosterone and someone who’s been doing it, then you’ve you’ve been afraid. 

Right. And you have such little training and again, it’s changed. So I think there have been small spurts where I actually liken it to GOP ones today, right? Every every two weeks, you will see a new research paper that says I think GOP ones are useful in this indication or that indication. I think testosterone actually had some of those, you know, silver linings. And then again, it’s just been it’s been mixed up with with a lot. And even, you know, in 1990, Congress scheduled testosterone as a controlled substance. So we know why. So this was really an outcry to Olympic doping. I think, you know, it may be, you know, you had other countries that were using this more and that was a disadvantage for the U.S. and there’s public outcry. So there was actually at the time is very important to know the FDA opposed it. The DEA opposed it. The AMA opposed it. So they did. 

They all opposed the scheduling, making testosterone scheduled and for listeners scheduling, scheduling the drug makes it difficult to acquire. Yes. There’s just barriers to being able to get the drug. 

It changes the perception immediately. Right. Because again, controlled is bad. Yeah. 

And then yes, it is an issue for providers across the board to to get access to to these medications. And that basically limits the amount of people will be on therapy. 

And there was a an uproar about it. The AMA they opposed making it scheduled. 

Everyone opposed it. Yeah, exactly. There are letters. Everything was written. So this was it was interesting enough. It was actually Joe Biden in 1990 that led that charge. 

That is fascinating.

So kind of we’ve come full circle here for sure. And and I’ll talk more about it later. We are launching a nonprofit that that de scheduling is is is a core tenant or mission of what that on. 

And when it wasn’t scheduled up until the 90s, correct, which means someone could go to their physician’s office and say, I would like to try testosterone. And I would like to try it in an off label use, I think still 80 percent or so of testosterone usage is off labels. 

Most most use is is off label. And here’s again fascinating part of the history. So until around 2014, there was in testosterone labels, the indication actually read for primary, secondary and something called idiopathic. So what that means is idiopathic hypogonadism. Exactly. So what that means is that we don’t know the reason why you have this this condition, but you have it. 

So we should again, we should treat it just like pretty much every other condition. You think about high blood pressure, you think about cholesterol, you think about depression. 

Physicians don’t get root cause is great to know. But at the end of the day, we also need to attack what’s going on or treat what’s going on. So that is the standard practice of medicine. Right. But in this instance, testosterone has been singled out and that has been removed from the label. So you 

mean it’s been removed and label idiopathic. Yeah. How would just randomly they decided that you 

because the FDA does not like testosterone. Controversial statement. FDA does not like testosterone. So they pulled it and they said, let’s make it harder to get. So let’s make this physician who knows this patient should be treated jump through hoops. Yeah. So not only do you have that controlled problem, you also have this label issue. Again, it doesn’t at the end of the day, you know, clinicians have the right and judgment and they can do that. But it adds to this this issue around the whole therapy. It does. 

It does. And if we were to find low testosterone levels, they seem to continue to move the goalpost lower and lower. 

Absolutely. Absolutely. So as recent as I think this was two thousand seventeen lab corpse reference range. The end of the bottom of the reference range was something like three twenty three forty nanograms per deciliter. That was the bottom and considered, you know, the cutoff. Now I believe that number is around two sixty eight. Right. And even I’ve seen some reference ranges dropped to two twenty two. Yes. 

Right. And that is considered quote normal. Exactly.

Exactly. So and again, you know this because of the way that you practice. But reference ranges are really a reflection of our population. And I think everybody knows our population is not healthy. So at large. So we are, you know, our goalposts, we’re measuring ourselves against something that we should not be or aim for. 

Yeah. And it’s definitely not optimization if we were thinking of really how do we age well? How do we continue to have a meaningful muscle span, which is the length of time we live with healthy skeletal muscle and able bodied if we continue to move the goalpost lower and lower. And then the other right south. And then the other thing is how is it. And I was looking at some of the guidelines yesterday. How is it that a 20 year old is still within the same reference range as a sixty five year old. 

Right. 

There’s there. That doesn’t make any sense. 

It was really arbitrary when when they had come up with it. Right. I think, you know, a lot of people in the space akin it to throwing a dart at the wall saying, all right, this is this is this is the reference. This is this is the number you shouldn’t be. It’s variable just like most other things in your body. Right. We measure glucose in the body and that changes day to day. But whatever you showed up to in that lab is how the physician is going to base your treatment on. And here you have something the same. You know, one day you might be two hundred and eighteen. One day you might be three hundred. So I think what we have to do is definitely look at symptoms. That is obviously the most factor, most important factor. But again, understanding its role in the metabolic health of a person. And I think now with the advent of oral, you have the ability to still optimize better so you can improve these underlying factors, whether it is cardiovascular health, whether it is cognitive function and so forth. So that’s why I think the research needs to be done. Again, these are not indications today, but that’s where we know the research should focus on because we know the reasons why low testosterone is bad. 

There’s thousands of papers. 

But you’re at risk for a multitude of things. 

Multiple diseases. Right. And, you know, again, big and for big things that are big problems in our societies, whether it’s type two diabetes and so forth. So we know why low testosterone is bad. We’ve firmly figured out that, you know, it’s not risky for cardiovascular disease or prostate cancer. And those those studies are unequivocal at this point. Right. So now I think the research can finally be free and say, look, here truly are the benefits. Right. So that’s where really we want to spend a lot of time is just on the next frontier. 

Yeah.

So whether that is as a GOP one combo or tell 

me more about that, because that that’s really fascinating. 

The so Marius Pharmaceuticals, do they do other we 

are we are supporting a lot of outside research right now. We have we have not launched the trials ourselves yet. I think a lot of this goes back to us working with the FDA and figuring out trial sizes and so forth. But we know there’s tremendous interest. Right. So again, GOP ones, for example, the whole conversation around muscle loss. Right. That’s it’s it’s been pretty much front and center. 

And obviously, yes. Like, are there a lot of foundational things that you should be doing? Protein intake is super important. Strength training, like wholeheartedly agree with these things. But we know population and sort of how they they act. So what pharma is doing and we don’t really love ourselves. 

And I also think that you should lay the foundation a little bit because basically what I want people to get out of this episode. Number one is understanding that they have other options and understanding a little bit about the history of how we got to where we are. Because arguably, you know, I believe in testosterone therapy for both men and women. I think that from what I’ve seen, it’s been demonized even if a small sector of the population like myself and some other people that are really interested in longevity believe in it like yourself and our colleagues at Baylor and various other places. 

To the large perception, 

it is still controversial. It is still unobtainable. 

They feel like it’s cheating or, you know, it’s almost like saying, if you go on testosterone therapy, that’s cheating. But then I would say cheating what? And if you’re a woman, you’re going to go through menopause. Right. What is your so you do hormone replacement, including testosterone and that’s cheating lead.

Right. Yeah, no, absolutely. They should not be, you know, folks should not be subjected to these things. I think it actually goes back to testing. Right. Honestly, if you think about testing, 

frankly, you know, every male over 40 should be tested and every female over 40 should be tested. Right. To understand, you know, what that level is because again, more and more so you’re seeing these deficiencies. 

It’s exactly interesting if you think about your overall health and diagnostic testing these days. Testosterone is is the single most telling barometer of your overall health because it’s not, you know, again, you think lipid panels or whatnot, your cardiovascular glucose, you’re thinking insulin. But testosterone will give you an insight into your cardiovascular health, your glucose metabolism, your inflammation in your body. Right. Inflammation is the root cause of almost all disease. So it’s it’s mind boggling to me that that and it’s a cheap test. It’s it’s less than ten dollars. Yeah. And and and yet if I were to walk into my primary care and say, hey, can you test my testosterone? They say why? 

And they definitely would say that’s wild. And I will give you some statistics. Forty percent, approximately 40 percent of men aged 45 and over are hypogonadal, meaning their body doesn’t produce enough testosterone. 

A U.S. study estimates an additional one hundred and ninety to five hundred and twenty five billion dollars in health care expenditures over 20 years due to testosterone deficiency. 

You know, this list goes on. Men with impaired fasting glucose or impact glucose tolerance typically have hypogonadism. Again, low testosterone. I mean, again, this list goes on and it’s not just for men. It’s also for women. Women seem to be under studied when it comes to testosterone. 

And I will also say this is interesting. It says a lifetime risk of progression from pre-diabetes to diabetes is as high as 74 percent. 

Right. Yeah. No, it’s it’s it’s you know, so that’s why I said the research is really clear and it’s and it’s and it’s been repeated and reproduced over and over again. And there’s the papers are

also there that that testosterone deficiency or low testosterone will result in higher all cause mortality. Full stop. Right. Like there’s there’s nothing more greater than saying, hey, you will die sooner if you have testosterone deficiency. And that has effectively been shown in the research and the literature. So again, testing. 

Understand if there’s an issue. 

Where do you think we could go with? Do you think that there’s any chance that we’ll be able to put a more reasonable guideline together? Meaning. Meaning. And I understand that you’re not a practicing physician, but again, you are in the business of bringing this to market, which is critical. And we need that. We need people that are willing to fund research so that someone like Dr. Mahakara or Lipschultz can go out and do this and gather this kind of data or Rachel Rubin or a friend, Rachel Rubin. Do you think that there will ever be a time and again, this is your opinion that we can change the. 

You know, the values, the numbers of where is low testosterone in men really 220 nanograms per deciliter is low testosterone in women really free testosterone really normal at zero point five. You know, I think, 

you know, the optimist in me is saying yes. Right. I think we are sort of entering this, this, this Renaissance of hormone. 

I’ve never heard that before. You said that we’re entering this hormone Renaissance. 

Absolutely. Because if he, I mean, just take the female side, right? Pre-WHI there were 40% of women were on hormone therapy, menopausal women, 40% of women pre-WHI were on 

the women’s health initiative. Yes, exactly. 

Which the study we know is total garbage, been debunked, retracted everything, right? But now because of that still 22 years later, there are 1.8% of females are in menopause or on hormone therapy. 

Wait, wait, wait. This is so important. We have to take a pause. 40% of menopausal women were on hormone replacement therapy up until the women’s health initiative. Correct. 2002. 

2002.

And then the women’s health initiative came out and talked about how dangerous estrogen and progesterone, I don’t know how much they talked about testosterone. 

They did not talk about it. It was mainly, you know, synthetic progesterone and estrogen. And that was the primary bit. 

That for 20 some years completely destroyed the public perspective as well as the physician perspective. 

Absolutely. 

So it went from 40% before the women’s health initiative to what did you say? 1.8% today. 

That’s disgusting. 

Yeah. 

1.8%. And so now we’re backfilling all this information of the positives. Yes. Of hormone replacement. 

And I think, you know, again, how do we change these things? Your question, I think patients, that’s why we spend a lot of time trying to educate and we really want to empower patients, right? I love for the medical community to come along and there is again, like a percent that is doing it. But I think the patients have to be advocates for their own health. And how do we arm them with the right information so they can go and do that? Because not everyone is going to go to a functional care doctor or integrative medicine and whatnot. They’re still going to their primary care or urologist and so forth and or their OB right. And they have to advocate for themselves. So I think it’s critical for us to educate them. And I think that will help as backwards as it seems that will help the societies get along and change the guidelines over time because they will see and believe it more. Right. They’ll reluctantly maybe start. And I think that that tide will shift. 

And how is Marius different than say, quote, Big Pharma. How would the person who’s listening think about Big Pharma versus various other pharmaceutical type initiatives? 

Sure. I mean, I think it even starts with with Kaiser Trax in it in itself. Right. Kaiser Trax is is aimed at a problem that is large. Right. Even just again, let’s just say. 

So we know that 40 percent of men over the age of 45 have hypogonaz. 

Correct. You’re in 20 to 25 million men easily.

And then again, you think about the female population again has to be researched and indicated for so forth. But I think the numbers are quite staggering. So what we’ve seen is this trend of Big Pharma focusing on rare disease. Right. And rare disease is important. But why? It really comes back to the way our system is set up and frankly reimbursements. So it’s a lot easier to get reimbursed for a rare disease drug than it is a mass market drug. So that’s really where the calculus has been over the last let’s call it two decades. 

And I think so. We again, we saw this as a mass market problem, but not as an issue around reimbursement. To be honest, we thought this helps people. It will do well. So that was part of the reason that we actually forego the insurance path, working with PBM, signing insurance contracts. We said, hey, this product should be cash and let’s make it accessible to as many people as possible. 

And Big Pharma, when one hears the term Big Pharma, is there a standard definition for that? 

I don’t think there’s a standard definition. I think there’s obviously you know, you can look at the size of the companies and so forth. But again, for us, we really consider ourselves different because I think this is more on the disease prevention side. Where can we come and help the healthcare system, right? We want to save dollars to the system, which is frankly here in the US, one day away from imploding. 

One hour. One hour. We’re minutes away from this, right? That’s right. How do we save this system and actually pull dollars out for the benefit of, I mean, patients, providers and again, the country, if you will. 

And who, can you tell me a little bit about how the oral testosterone is absorbed? So it’s lymphatic absorption. Yes. Also, the length of time that it stays in the system, right? So there’s cipinate, propionate, there’s, you know, they seem to have various half-lives. Correct. And also just the impact of oral. Oral seems to not raise blood pressure as much as an injectable would. And it seems to have less of an impact on hematocrit, things of that nature. Correct. And maybe even potentially fertility. 

Yep. That is, again, we’re running a study here. I think that data is going to be, there’s an abstract being published in October 2024. We’ll see the full results in 25. But the data is pretty encouraging. So we’re excited for that to be announced. But in terms of how it works in comparison or again by itself, you know, daily, oral is taken daily, right? And that’s actually twice daily right now. So what we see is-

Which is great, an improvement from three to four times a day. 

Exactly. Yeah. From previous versions and whatnot. So this is, this is definitely rather convenient for men, right? We’re living in a society we’re pretty used to taking pills. We’re usually taking a number of supplements. So everybody has their box that they’re getting ready at the beginning of the week and, or traveling with it and so forth. So the half-life, what we see is around five, six hours, right? And then usually you take a dose in the AM and you’re taking a dose in the PM. 

What we’re seeing is that 

And what’s the total milligram dosage? 

So what we, so there’s a range of doses that are available, you know, to titrate, depending on if that patient is a super responder or where they fall on the spectrum in terms of response. But most commonly, we see 400 milligrams, BID. 

And it’s important for people to understand that is not the same as injecting. 

Correct. You cannot, you cannot sort of just equate what Kaiser Trex is doing to an injection in terms of the quantities, right? Because again, this is being delivered through your small intestine and bioavailability differs. 

But ultimately you look at the result in the labs, right? 

But what we’re seeing or what we’re starting to understand is that because testosterone is produced on a daily basis anyway in your body, right? That’s the circadian rhythm. When you go to sleep, you’re obviously producing your hormones and that’s peaking in the morning and going down throughout the day. The closer you can mimic that without going to super physiological levels and super physiological. What I mean by that is then, you know, often injections take you to, 

it could be actually a post injection data would show you could be at three, four thousand nanograms

per decimeter. Really? Well, I’ve never. 

Just immediately post injection, right? 

Everyone would, I’m sure all the guys would love that. 

Yeah. But we don’t want to do that. 

No, we don’t want to do that. 

We don’t want to do that. I’m sure it’s a great feeling too. 

Yeah. I don’t know. I’m just asking Matt, Matt the producer. I’m just kidding. 

So yeah, it’s it’s it’s and again, as more folks are using this, you want to reduce the chance of error. But by reducing these these high super physiological levels for extended periods of time, what we see in the data for for Kaiser trucks is say the himatica, for example, sub 2% of our patients developed a himatica level above 54. 

And and then also that was being if you down titrate that was solved for. And if you look at some of the real world data and we have abstracts being published on this as well, 

you can also take a patient that has high himatica and then they can lower that by switching to an oral 

from an injectable. Exactly. Which is which I think is a real benefit because we know that injectables increase himatica and that’s the one thing where people don’t necessarily want to go donate blood. It is. It’s a bit of a hassle. They might not again. Some people feel great. Some people don’t. But if we can avoid that, then that’s wonderful. And also travel. 

Right. 

We have a lot of guys that travel and also I definitely want to talk about women. The idea of an and my husband, am I allowed to say this was in one of the studies for Kaiser tracks. So I have a wife clearance. So I’m allowed to say all the things that I don’t know.

So yes, he was and he loved it. Right. And he found it super convenient and how he did it was he would take it in the morning with a meal and then he would take it in early afternoon as opposed to take it in the evening and he he felt great. I don’t know what dose he was titrated up to, but I do know that he his levels were considered more optimal for him. And I think he personally sits around 900, which is where he feels great. 

So I’m curious is to 400 milligrams. It goes up to 400 milligrams twice a day. Correct. 

Do we know because absorption is variable. Do we know if someone is on 400 twice a day, how much of an increase we can get? 

We would expect. So if someone is either at 300, I’m sure you have hyper responders that would go to six or 900. 

Correct. So even at a slightly lower dose on average, if you take your hypogonado mail and this is data from our phase three. So they would probably be on average at low twos, right? Their C max would actually be in the nine hundreds. So, you know, you have that 700. That’s amazing. Roughly point increase to C max. And again, this is a daily rhythm, right? So you’re hitting that on a daily basis. But then at the end of the day, you’re going back down to your baseline. So that allows you know what we see in the data is that the LH and FSH, right? The signals that are coming from your brain to produce testosterone are not going to zero. 

And why is that? And I think this is really important for people listening and especially for the younger population. Fertility is a big thing. Right. And it’s, it’s fair to say that if someone is trying to get pregnant, or wanting to have a child that they should not be on testosterone replacement therapy. I will also say that people feel really terrible when they are coming off of testosterone replacement therapy. I mean, there’s ways to do it in which you do a titration. But one thing that I thought was really interesting is that it seems as if the oral doesn’t affect fertility the same way is, is that fair to say 

that again, the data will definitely show that. So we’re really excited to get that out into the public domain. But I think as a surrogate on understanding what’s happening, 

to those signaling’s not dropping, then those obviously affect, you know, the sperm counts in those males. So again, the data will kind of play out. But I think we kind of use the analogy of and this applies for men in general, right? If they’re just considering testosterone replacement

therapy, we have a factory, it’s working, right? Or maybe it’s not working so well. So we’re deciding to go on testosterone therapy. If you’re going on an injection, you’re likely shutting down that factory and sending all those workers home. Factories closed. Factories closed. No, I’m not operational. If you’re taking oral, because again, using the LH and FSH as the surrogates, it’s more like, okay, we’re going to shut down some of the equipment, we’re going to send some people home, but we’re still going to be working. 

You guys are going to have a long lunch hour. Everything is going to be fine. 

Yeah, exactly. We’ll bring you back when the time’s ready. So the lights are staying on, right? And this actually even if you’re not concerned with fertility, 

we don’t have reports of testicoratrophy. 

Which is also a really big deal. You don’t? 

We don’t have reports of testing. We did not see it on trials and we did not see it in, again, some of the abstracts that will be published in near term. 

Isn’t that amazing? What I mean, what would, what were you thinking about this? Because that’s a big complaint. It’s a huge complaint. So when men go on hormone replacement, they have, they get testicular atrophy. Oftentimes physicians will use HCG to counterbalance this. This is now another three shots a week or so. 

And the fact that you would be able to take testosterone without shutting down FSHLH fertility, potentially. I mean, I think that probably, I mean, I guess we’ll see when the data comes out, but no testicular atrophy is huge. 

Exactly. Yeah. And again, it’s just, this is, we’re trying to sort of make people understand the importance of the therapy and get treated for the right reasons, right? So I think it’s kind of like men’s health. Men’s health is a bit of an epidemic in itself, right? Guys notoriously don’t have doctors. I think the stat is, I think between 18 and 40 or so, you know, at least half or 60% of guys don’t have doctors. 

Because again, most of the issues don’t present, but say you bring in libido, right? If you have, or ED, if you have an ED issue, you’re going to show up with that doctor tomorrow, right? 

Right.

Right. 

So if you have erectile dysfunction, you will be knocking at the door. Exactly. 

But that actually, in some sense is a perfect opportunity to say, okay, let’s test for your testosterone. Let’s see what else is going on, whether it’s your cardiovascular system, whether it’s, are you pre diabetic, right? What are some of the issues that are driving to this ED, right? So I think, I actually, for providers and patients, like this is the best way to take charge of your health again, recognize this and then go in and then again, advocate, understand. Understand what you should be asking for. So at that point, you know, again, ED is a vascular issue, right? So let’s, let’s kind of address some of these issues. 

Which could also be a metabolic issue. 

Absolutely. 

All right. When you think about what are the issues that create an atmosphere of erectile dysfunction, low libido, low testosterone, you know, in my mind, it definitely will start with metabolic dysfunction. I mean, maybe does it start there? Is it the chicken or the egg? 

You know, either way, it has to be addressed. 

But yeah, again, I believe it’s there, right? That I think that metabolic syndrome to write dysfunction just just is so core to what’s going on in this country and globally. And it needs to be again, it needs to be discussed more. And what are the markers for it? So if we’re able to bring those things to light, I think folks will be able to pay attention and and treat them appropriately. You know, 

and speaking of this idea of metabolic profile, so there’s many studies showing testosterone therapy has a positive impact on the progression from pre diabetes to type two diabetes, improving lipid profiles and reducing body fat, improving skeletal muscle. 

Are there specific metabolic benefits of oral testosterone therapy versus injectable? 

So we’re still studying this. And I think what’s interesting, at least if I look at anecdotally on the anabolic side, right, because because of the circadian rhythm matching, anecdotally, we’ve seen better anabolic effects. So folks that have been on testosterone therapy for say, extended period

of time, see a bit of a diminishing return, right, whether that’s the angina receptor that’s been overly saturated for too long and how it responds. 

It’s an hypothesis. So I think going back and getting that time off, right, that that nighttime is that time off. 

That is I’ve never thought about that before. 

It’s again, totally anecdotal. But this is this is something that we definitely want to study more because I think it it it allows for patients and providers then to say, okay, we can use this as a as a as a wider tool in our toolbox. 

So can you expand on that a little bit more? Basically, testosterone has this diurnal release, meaning typically is released twice a day, follows a circadian rhythm. And you’re saying that with the oral testosterone, it is different than injectable. And the impact of it almost augmenting, I don’t want to put words in your mouth, but augmenting a circadian rhythm seems to have more of a beneficial effect than other forms of if you’re taking it three times a week, because you’re taking it sub q, right? 

Yeah, once at the end, at the end of the day, anything that’s not daily is not physiological, right? The term, I’ll even say the term bio identical is used a lot, right to say, Hey, look, this is a bio identical hormone. But for example, if I’m putting pellets in you for three months, your testosterone is not produced for a three month period that way, right? So I think physiological is bio identical. 

I do think that whether someone is a provider or is a patient or interested in this, this is a very good point that if something is to be quote bio identical, it should match the way in which the body is producing it. And oral seems to be a way in which that makes a lot of sense. I do think that potentially we’re going to see more about this idea of circadian biology. 

And I think if we can do and utilize medications that mimic and ride along with circadian biology, I personally believe that we’re going to see more beneficial effects. Right. And then, you know, the other thing that I would think about is what about women? How do we think about the utilization of oral? 

I mean, women use oral estradiol all the time, they’ve used oral birth control. Where are we at with understanding testosterone for women? Sure.

So I think it’s a super interesting area if you think about it, right? And not to make this a male versus female, but you go into a pharmacy and you’re a male, you have like 30 options to go and pick your choice. What do you want for testosterone, right? If you go for the females, there is not a single FDA approved female testosterone, zero, right? And that’s just an injustice, right? 

But, you know, I think for the female side, what’s happened since WHI2 is that providers and people in this space have really understood how important testosterone is in a female body. And actually testosterone premenopausal is at, you know, I think it’s 10, 20, 30 times the amount of estrogen in a body. So it is a female hormone. It’s, I think we have to get past this notion that it’s just a male hormone. It is a female hormone, critical. And again, if testosterone affects depression in men or cognitive function, if it affects insulin sensitivity in men, if it affects bone health, muscle mass, 

tau proteins, whatever you want to, you know, put out there in that sense. It has to have similar ramifications for the female. And I think what’s happened is that because of guidelines, it’s been pigeonholed into a sexual dysfunction issue. And that’s not- Hyposexual. 

So it’s typically used for a hyposexual desire disorder. 

But what about, you know, getting the female that’s, you know, 50 years old that has, you know, early onset of osteoporosis, right? What about them? We know this is important in bone health. So again, total preface that this needs to be studied specifically in these populations. But I think what we need to see honestly is a thought process shift in the sense that females have testosterone deficiency as well. Full stop. It’s not, it’s not, again, a sexual dysfunction. It’s not just one area of indication. We need to understand that they have this deficiency and we should understand that it likely should be treated. And we can get into, obviously we can do the work to say, okay, these are the ranges, at least to give guidelines to practitioners and so forth. But let’s not put this into a small, small bucket. 

And then could Kaiser tracks be used off label for women? 

Yeah, we don’t obviously have an indication for it. So I can’t, I can’t recommend that we are supporting research in this space. So we have investigators that have come to us and said, hey, look, we want it. We want to work on a female study and we think these are the appropriate doses and they’ve also gone to the FDA and said, hey, look, this is what we want to do. 

I mean, we use, and I, and I speak for many of the providers listening and many of the people listening that are women, I’m sure many of them are taking testosterone, which would be considered off label for low libido or even having low levels of testosterone. But I do think that if

there is a way to mimic the natural circadian rhythm in men, we should also be offering at some point for women. 

You know, is something like this? If a provider was looking to offer it to women, is that something that you think will be available? So 

from right as we discussed earlier, right? Like providers have a hundred percent clinical discretion in what they do, right? So there is there, they wanted to take Kaiser tracks at a hundred milligrams QD once a day and do that. That’s totally their discretion. I think you’re going to see, you know, there’s this massive menopause movement, I call it, right? Which is just, you know, fabulous physicians that have gone out there and been really vocal around this space. And I think they understand and they talk about how important testosterone is, right? So female, I mean, anecdotally, I won’t, I won’t describe exactly how she’s related in some sense, but, but, you know, I had a, I had a colleague, let’s call it, call me and say, hey, look, I just got on, I got back from a girl’s weekend. Six of them. She’s like five or six of us are on testosterone. 

And I’m like, wow, that’s just, that’s, that’s in some sense, it’s amazing. Right? Because you feel better. 

Yes. 

Yes. Like that’s what you’re telling me. And, and so I think it’s, it’s our job providers and investigators. And then frankly, I think I go and going back to that nonprofit that I mentioned. 

Tell me about this nonprofit. What is it going to do for people? Sure. 

So it’s called the testosterone project, right? The testosterone. 

I’m assuming it’s about testosterone. 

All about testosterone. Absolutely. 

But we have three main missions, right? The first one is testosterone testing. Let’s make this standard. This should be, I mean, frankly, the, the US preventive task force should say you should be measuring testosterone because that’s what’s good in preventive task force, right? 

Would it be free total? Have you guys thought about that? Ideally,

I so, and we, I’d love to talk about free testosterone, right? Because as a concept, that’s really what we need to be talking about because that’s all that matters and all that you can use in your body. So I think it should be free. I mean, ideally we look at total T, we look at free T, we look at SHBG. And I’ll definitely get into that as well. Yeah, 

because I’m curious, does SHBG go down with oral? 

So uniquely, 

SHBG drops by, by in our phase three studies, SHBG dropped by 30%. And some of the abstracts that we’re seeing published, this can range up to 50%. 

So we have to take a pause because I think that this is a really important concept. 

Sex hormone binding globulin is a protein that is made by the liver. And here’s what happens as individuals age, especially men, we see men and women, we see an increase in sex hormone binding globulin, which then binds free hormones are like children, they can’t go anywhere by themselves, you need sex hormone binding globulin to walk around with them. And the issue with that is it binds free hormones. 

When you go on birth control, sex hormone binding can, or birth control or even estradiol, anything oral seems to elevate sex hormone binding globulin for a lifetime, which is a problem. 

It’s a massive problem for birth controls. I guess, I don’t want to say taking time on, but that’s just huge, huge issue. 

If you then can no longer access the hormones that you’re making, 

what you’re telling me is that this oral formulation can actually lower sex hormone binding globulin. To me, that’s, you know, in my mind, I’m thinking, well, gosh, even if someone wants to use injectable, I would say, okay, if we measure your sex hormone binding globulin, and your SHBG is elevated, or higher. And when I think about elevation, whether it’s between 60 or 80, to me, that’s on the higher end, you know, I’d love to see that lower. Would someone be able to administer an oral testosterone to lower that?

Absolutely. So it’s, it’s, it’s, and again, I think you’re just seeing it more prevalent, whether it’s with age, some lifestyle things, even alcohol use, right? Has, has seen SHBG levels rise. And I think that’s probably part of the issue even with the younger, younger male too. But yeah, so we uniquely take down SHBG. And then what that does is allow the testosterone to be used. So free testosterone, as we refer to it, goes up phase three study to X, in abstracts, we’ve seen closer to three to five X. 

So this wild. And again, so what’s really interesting in this new paradigm of testosterone therapy is we can see testosterone through oral rise to let’s go on mid normal levels, right? Maybe you’ll on average get to seven, 800, right? 900. But your free tea goes up preferentially. So the ratio of total tea to free tea is better. 

Then it would be on an injectable or something else 

injectable. Well, you’ll take your total tea up, right? So you might go up to 1200, 1500. So that free tea level might be the same then, but then you’re also dealing with what are the consequences of having your super physiological testosterone for a longer period of time. 

That’s amazing. What would be some reason, a contraindication for men or women who are thinking about changing up the way in which they utilize testosterone? 

I mean, frankly, as a comparator, the contraindication would be like, you don’t like taking your pill. Okay. There’s, there’s, there’s, we haven’t found any. 

Like, would it make sleep out of it? You can fact check. 

I can’t find a reason why that, that again, unless you don’t respond, right? Which again, our clinical trials, 96% of patients got to, you know, normal levels of testosterone. Let’s call it even 80 odd percent in real world. 

So it’s interesting. 

Would it worsen sleep apnea the same way potentially an injectable will? Would any form of testosterone?

Right. So we’d love to, again, I’d love to do the research. I think we go back to our daily circadian rhythm. So like, if your testosterone is effectively flushed from your body at the end of the day, the exotics, what happens, right? So yeah, again, we, I think we, we, I love to call it any provider that’s listening and say, Hey, look, we’d love to run these studies because we’re, we’re, I think these are, 

all incredibly important points to change the way that this therapy is viewed. 

What about, I know that it’s absorbed in the lymphatics and small intestine. What if someone has celiacs or some kind of Crohn’s or just an inflammatory bowel disease? Right. 

So there is data on this actually. So there is data around testosterone and, and, and Crohn’s IBS. 

And, and we haven’t seen, we haven’t seen issues dealing with absorption. So anecdotally, again, we have, we have providers that deal mainly in GI and gut health and, and have not had, you know, reports of saying, Hey, look, Kaiser tracks doesn’t work. 

We definitely, again, we would love to do the research there because at the end of the day, like we talked about, you know, our bodies are inflamed and, and most diseases is, is caused by this. So if we can take down things like your CRP and your IL six and so forth, these are all inflammatory markers, right? If we can take those things down, there’s, there’s a good chance that, that you can help some of these things. 

Yeah. 

Where do you, where do you kind of see the oral testosterone being synergistic? Have you thought about what are things just, just throwing this out there because I think it would be interesting. Do you think that there’s some kind of synergistic effect of if we’re going to make oral, you know, or you already have are making Kaiser tracks. Could there be some other synergistic oral compound potentially that one would use?

Sure. I think like we see it initially with other therapies, right? So like, take for example, GLP once obviously, you know, this is a huge topic of today and a lot of people listening are familiar with them by now. But, but muscle losses, you know, I’m sure, you know, you’ve talked about right to understand. Nope. 

Never talked about it. We don’t even talk about muscle on this podcast. No one is interested in muscle. 

We need to, we need to definitely bring it up. But I think, you know, outside of all of the things that one should be working on. So we, we, we, with a partner of ours, they’ve launched a study to look at what muscle preservation is on semi-glutide by itself versus semi-glutide and Kaiser tracks. 

I mean, that’s amazing. 

So because you, you know, again, I go back to, to, to pharma and right there, they’re looking at a lot of these assets that are, are frankly all the rage to say, Hey, look, we know this is an issue. How do we work on this? Whether they’re myostatin inhibitors or whatnot. But these are all early stage assets that honestly at one time or another had been discarded. 

And when you say early stage asset, you mean Kaiser tracks would be. No, no. 

So these are like for muscle preservation, like lilies of the world have partnered with other companies that they’re like phase two or maybe even earlier. So these are probably three, four years away from an approval. 

Okay. So basically what you’re saying is there’s drugs that go through up to phase three trials. Exactly. 

And these are early, um, 

early drugs that may have been discarded. Exactly. 

And it may not work, right? Because again, you have to get through phase three trials where you’re in enough of a population. But I go back to testosterone being around for a hundred years. People know it’s safe. They know it works. 

It’s crazy. And then they scheduled in 1990, in the nineties, they then schedule it and create a barrier of entry for utilization.

Correct. And again, as you know, muscle is important. This is not the enemy here. We need to, we’re an under-muscled country and under-muscled population. So how do you, again, and a lot of folks talk about how do you make sure you can do the things you want to do? As you, you know, health span versus lifespan, right? Can you put your suitcase up on the, on the, in the plane, right? Like something as simple as that or prevent a hip hip fracture. So sarcopenia, which we haven’t even talked about. And, and again, we have all of these areas that we’re looking at research. 

Let’s talk about sarcopenia. Let’s talk about, 

do we believe or do you believe or have you seen in the literature that the oral testosterone has a greater impact on certain areas, maybe more so than inject? Well, again, all testosterone, I believe all testosterone is beneficial. Sure. I know that there may be a uniquely beneficial fertility preserving aspect of oral. Do we feel like there are other, or do you think that there’ll be other emerging data that this formulation of the way that this delivery system is done because of actually this really diurnal administration? Right. 

So I think, I think, like you said, it will come back to that. And I think we will see, as we continue to do that research, we will see, let’s call them very interesting effects on, on that population. And again, various populations, right? 

Wouldn’t it be fascinating if the impact on skeletal muscle was greater because you’re able to influence muscle cloches? 

Yeah, absolutely. 

That would be phenomenal. 

I think, yeah, again, just, just for patients to be able to really embrace these therapies and put them into their toolbox for, let’s, let’s call it longevity, right? What is longevity? 

It’s, is that living better and longer? But if you look at the pyramid, it’s, it’s some of the foundational stuff, right? You got to eat well, you got to exercise, you got to sleep and manage your stress. I mean, mental health, right? This is a huge, huge issue for both male and female. But again, it’s often ignored. So I’ll just talk about that for one second. Again, our best friend, Molly Keira, I did an amazing paper on, on, on depression and low testosterone, where he found this was about 1000 patients. So not a small number by any means. 92% of patients had depressive symptoms and low testosterone. Almost 20% of patients had moderately severe depression in that analysis.

And actually that moderately severe group, I think that went from like, it was 17 and change down to 2% after three months and 12 months of testosterone therapy. Isn’t that crazy? Huge. Again, and that’s why, as I said, when we started all of these things are intertwined. Go back to testing, right? If these folks are men or women were just tested, right? You would understand this and then you would have a better approach to their, their treatment paradigm, right? And we know SSRIs are out there and I’m sure they’ve helped a lot of people, but they’re not the end all be all by any means. So how do you make sure like, what’s the root problem? Let’s find out what’s going on there. 

And how do you guys plan on educating the public? I mean, you’re doing this. I mean, this is really, I was so glad you’re willing to come on and so glad you’re willing to support the podcast because it’s needed. 

But how else, so the, the podcast educational outreach, do you guys have a game plan for that? 

So yeah, I mean, again, it’s really just, it’s, it’s kind of a full court press on, on, on all outlets, right? Obviously you have your channels through, through traditional PR. You have new media like this, social media. I mean, rethinktestosterone.com. That’s our, that’s our disease state website. And, and all we do is, is look at these literature and these studies and, and bring light to them because what’s, what we’ve seen, at least in our journey is that the research has been tremendous. So I think on a previous podcast, you had mentioned, you know, the androgen society, right? Great, great minds, all focused on andrology and folks like Abe Morgan Taylor, who we worked really closely with since inception. 

And he’s been doing this for, for probably 40 years, right? And, and so we’ve kind of said, okay, let’s take the next step. We need that microphone. The not, you know, to testosterone project as a nonprofit. Our goal there is, is obviously using science as our foundation. But we see this as being, you know, a million patient strong advocacy group. 

So what is the testosterone project going to do? 

So the first thing is going to be testing. Second is going to be female testosterone. So how do we go to the FDA and say, a trial for females should be, should look like a male trial. We shouldn’t have these onerous expectations or thousands and thousands of patients that need to

be trial because we know that’s why folks have stayed away from this because they’ve made it infeasible to, to run these studies, even though the data exists, right? It’s good. We know it works. 

Why are they, you know, why are they holding ground? Right? True. Again, Traverse should have, frankly, the FDA should have came out already and changed the label. They should have fixed the label. They did it. They asked for Traverse. 

And then Traverse trial was the trial that looked at the impact on cardiac. There was multiple arms. 

Multiple arms, prostate, et cetera. Main one was cardiovascular, right? Patients, gold standard, randomized, placebo controlled, right? This took seven years and hundreds of millions of dollars because the FDA said, hey, look, you have to do this. 

And so they should actually, frankly, they should have came out already and changed that label, but they haven’t. So I think, again, we are, Marius is taking steps there, but I think the testosterone project is, is really for patients to say, hey, look, we have a voice here. And what, what you do, the decisions you’re making are impacting our health. 

Yeah. 

Right? So the third point in that is de-scheduling testosterone. 

How long do you think that, have you talked to our colleagues? How long do you think that that? How does something like that even happen? Sure. So we’re pretty, yeah, 

no, it’s a, it’s a good question. Right? So we’re, we’re, we’re fairly active in DC, right? Again, if you asked me seven years ago, would I say, Hey, I’d be, you know, going, lobbying, going, going. Going, lobbying Congress every month and, and trying to, you know, move, move the needle there. No, absolutely not. 

How does that work? You just go, you show up, you say, Hey man, by the way, have you ever tried, you know, what you should do, you should put in the water. Yeah, absolutely. You should put in their water. And then have you just been feeling so amazing lately? 

Absolutely. I invite any member of Congress or anybody in the Senate to call us and, and, and get on Kaiser trucks. Um, because I think, you know, under, again, frankly, like patient stories, understanding what this means, right?

So what, how to make this unscheduled, do you have to go to Washington? What does someone do? 

So it’s a combination of, of, I think, congressional support and understanding again, this, this is, this is good for patients, people. Again, at the end of the day, Congress represents people, right? So that’s why the testosterone project as a patient advocacy, I can speak to them. If I have a, if we have a million patients or half a million, whatever that is coming in saying, Hey, look, here’s the data. Here’s the science. And that’s the beauty. We’re not shooting from the hip. Right. It’s so supported. And, and you take that and you say, look, why don’t you, let’s pay attention to this. This matters, right? We talk a lot about insulin prices and so forth. That’s one, one healthcare topic and, and access and all these things, but this isn’t, this isn’t, let’s call it an easy thing. I think for, for them to get behind. So then they have to work with the agencies, right? The FDA, the D the DA controls it because they, they control scheduled products. Um, that falls into their peer purview. And then the FDA is of course going to opine as well. He’s not a scientific agency. So FDA is going to opine and that’s why we’re asking the FDA be scientific. This is not, um, 

this is not 20 years ago. There’s not 30 years ago. We have the data that says what’s safe. 

We are hearing over and over again that testosterone is safe for men and women when it comes to telemedicine, right? There’s an increase in telemedicine clinics, telemedicine practices. 

Do you think that that’s breaking down barriers to access or barriers to access and where does Kaiser tracks fit into that scope? 

Absolutely. So I think telehealth is breaking down barriers. It’s a, it’s a much needed, um, solution in our system. I mean, look at in this country, we already have a shortage of doctors, right? That’s, that’s just bar none. We have a shortage of doctors and then we have a shortage of specialists, especially hormonal specialists. Right? So, so, you know, as we talk about patients and they’re seeking help, where do they go? Right? I think if, if everybody could go to their provider or their current provider and have that sort of, that’s called TLC, right? I mean, the system is set up that a provider has seven minutes with you, right? How in the world for a society that has these issues. Yeah. Yeah. Like you got all these issues, right? How can you go over them and take control of your health? It’s impossible. So I think, I think telehealth provides an outlet for these patients. Um, I think there will be in, in all sort of new areas, right? There’s a spectrum of providers and I think there’s going to be your great holistic providers down to the folks that maybe shouldn’t be there. Right? Yeah. Well, the beauty is that that’s why we have a regulatory system and those can be addressed. But at large, if it takes six months to see a urologist or endocrinologist who may or may not actually still be good.

It’s actually really tough. Yeah. It’s really tough. So if I, you know, as a provider or even as a patient, say, okay, someone comes to me and says, let’s, let’s put it from a physician standpoint. My patient comes to me and says, you know what, Gabrielle, I have been reading about chisotrax. I want to take it. How do I as a provider go about prescribing it or what do, what is the interaction with that patient? 

So for you, you know, as a practicing physician provider, like that’s, that’s relatively easy. We have, you know, pharmacies that are set up mail order pharmacies. So it’s not going to be sent into your CVS. We have set the distribution network such to basically control the pricing. So it doesn’t get high for the patient. $150. $159 if you send it to them, which is frankly the copay for a lot of people’s drugs, which is amazing. So yeah, I think that’s, that’s very, very reasonable. We do have some, let’s call it concierge practices or, you know, there’s testosterone programs. What you see today often are bundle programs. So maybe it’s the physician visit, the labs and chisotrax, right? That might be 199 bucks a month, but that’s, I think there’s tremendous value in, in now, again, physicians can either send it to a mail order pharmacy or they can create the programs. 

And when they go to the chisotrax website too. So if there’s physicians listening and they’re like, wow, I, which I really strongly recommend. And again, I’m not giving medical advice. I just, the goal is to hear, educate. A lot of providers listen to this podcast. 

I strongly recommend they try it for their patients. Again, my husband tried it. He’s still taking it. And it just was so much easier for him. 

Some guys don’t like needles and the gels. We have two little kids. I didn’t want him using a, any kind of gel preparation. Cause I didn’t want to get in on our kids. So if someone is interested, they would Google chisotrax. 

Yep. Chisotrax.com for the physician, they can go to the provider side. There’s a clear link how to get it. And there are our pharmacy partners. So we have a couple of pharmacy partners, depending on how your practice is set up. One will fit it. No, no matter how you’re currently doing it. One of our pharmacy partners will fit the way that your practice. 

Just out of curiosity, what is the dosing? So the highest dose is 400 twice a day. What are some of the other dose? 

So then the other two most common doses will just step down to 300 milligrams, BID. And then you’ll have a 200 milligram, BID.

Okay. And let’s just say, I know that it’s not FDA approved, but let’s just say someone we’re interested in. So the 300 or 200, how could we think about that? 

Not, 

I mean, obviously it’s not the same as an injectable, but would that be, for example, when we think about giving testosterone to a woman based on an injectable, right? It would be, 

maybe we would give them maybe five milligrams. Whereas a male, we might give a hundred to 200. How would we, or is there a way to think about it? Sure. 

So usually see like a 10th of a dose, right? That’s kind of the rule of thumb. So, you know, right? If we have 800 milligrams is a common, common male dose. You do have a hundred milligram capsule that is, you know, so it’s one eighth. It’s not exactly, but it’s one eighth of a, of a four, you know, that, that could be, I guess a female dose. We are again, supporting a study that is actually going to look at a 50 milligram dose. So that’s going to start as well. That’s amazing. 

And then would that be coming from, would that come from a compounding pharmacy? How? 

So no, no, Kaiser Trax is not compounded full stop, right? Kaiser Trax, you know, again, it’s FDA approved and, and we have our manufacturer partner for the last 12 years, right? Since our early studies that, that makes Kaiser Trax. And it’s, I guess a good way for, for the listeners to think about it is it’s like a soft, it’s a soft gel. Yes. It’s kind of like a fish oil capsule. Yes. Right. I wish I had one in my pocket, but 

let’s just check in Matthew’s bag. 

Exactly. But again, it’s like a fish oil. So, so would not be compounded. I think that’s a, you know, 

important point.

Right. Important point for, for, for patients to understand. It comes directly from us. Whenever it’s coming from the pharmacy, you’re coming in a one month supply, 120 tablets in that, in that bottle. And that’s a one month supply. So very simple. And, 

and if someone was interested in getting a smaller dose, like a 50 or a hundred, they would contact. 

So the hundred milligram doses is commercially available. Okay. Exactly. 50 milligrams. So the 200 is a hundred twice a day. 

Well, so no, there’s actually a 200 milligram capsule. There’s one 50 that you take twice with that. And then there’s a hundred milligram capsule. So we have three different capsule strengths to get to those doses. 

Oh, I see. Oh, amazing. Okay. 

So there’s a lot of flexibility there for the provider, right? Again, depending on how people respond, what we do see anecdotally, 

often again, injection switches tend to be at that higher dose. 

So can you give me an example of what it would look like to transition someone from if they were taking 200 milligrams a week? 

So if they’re anywhere from, if we’ve seen anywhere from a hundred to 200 milligrams test sip a week, right? Often still that 400 milligram dose works. So what else, what I’ll share is, so this is again being published in October of 2024, but it looked at patients on all on 400 milligrams, uh, BID, uh, twice a day. And if you look at the efficacy parameters, whether that’s test, I mean, total T or free T, you see again, the, the rises that you would expect. But interestingly enough to on the hematocrit side or the LH FSH side, you don’t see hematocrit spike. I think the data will show it won’t get above 50, um, in, in this patient group. 

Which is great. 

It’s really reassuring, right? Um, for, for both patients and providers. And then again, your LH and FSH don’t drop to zero. 

I mean, that’s amazing. 

So they’re active.

So the way you should have fertility, 

we haven’t talked about is also the conversion to estrogen. 

Let’s, oh yes. 

That’s a big concern for injection patients. Yes. 

Um, what is the average conversion of testosterone to estrogen? If it’s injected, I think it’s, um, do you know the number of? 

I don’t know offhand what the exact conversion is. 

I have to look, I want to say it’s between six and 10%. Not sure. 

Right. But it often what I can go back to super physiological levels. You have this, you’re going to convert more to estrogen. So, so for us that, that our testosterone to estrogen levels stay in, in line. So you don’t see folks taking an Astrazole, right? That’s often honestly with injections, right? In a lot of places that’s like comes automatically with your testosterone script. And, and we, we, we don’t see that, which I think is quite nice because at the end of the day, estrogen is also an important hormone for the male. It’s also a male hormone. 

Yes, it is. 

Right. So, so we don’t want to take that down or block it. 

I didn’t realize that, that there is less of a, an estrogen conversion. Would it, do you think that the oral may be better for people? And I’m just speculating here with body composition issues. 

Absolutely. I think it’s a good point, right? Because again, if you’re, you have body composition issues or you, and you’re taking a gel, for example, right? Yeah. Adipose is, is, is filled with, with that and it’s going to convert. So I think that’s why we see a lot of, uh, sort of obese folks struggle on therapy and then on AI’s and whatnot. So, and then just the variability in, in sort of absorption, right? Yes. Um, I think this provides a great solution for them. 

Because whether sub-q or IM, you still have to get through that tissue. I also think that it, it provides a great solution. Um, where do you think this is going in the future? You know, where, where are you guys hoping that Kaiser trex gets to? Are you hoping that, um, I don’t know that there’s some for men, some for women, that it is easily accessible. Sure. Where is it going? 

Yeah. No, good question. So I think it’s, it’s, it’s a bit of both for sure. Right. Again, we were definitely, you know, we’re committed to the research for sure.

Which is, you know, Mo always says, follow the science, follow the science. 

Yeah, absolutely. Because I think we, you know, honestly in our, in our, we know it’s, it’s down the right path. Again, the literature, there’s no shortage of good data. 

Which is why I wanted you to come on and talk about it. 

So we just need to continue to show the story with Kaiser trucks, to be honest, right? So if you think about the male side, you think about future research in women. And a lot of people ask me this. They actually ask, okay, hey, what’s your next product? And I just kind of, I just pause and I say, 

look at all the things testosterone. We don’t need another product. We need to educate and make sure that yes, we are doing the research and showing what that is in these different populations or different comorbidities, right? Um, I think that’s really where the greatest good will come to the public is understanding that and then thinking, okay, Hey. And also again, we want to show it. I love to have it on, on our label for, um, you know, a type two diabetic, 

or you look at like, I mean, that would be amazing. Yeah. 

I mean, look at that. Look at the sheer number of type two diabetics we have in this country or the dollars that are going in healthcare spending because of this, right? So if we could, you know, T4DM, I’ll bring up this study. It was done in Australia, probably published in 2020 now, maybe 21. Um, again, thousand patients, randomized controlled trial. And it, and it looked at the progression of. 

Pre-diabetes to type two diabetes, and it was almost nil progression of that. And then you also look at the reversal of type two diabetes down to, you know, a normal, uh, glucose eight, a one C actually they used OGTT, which is even a better metric, 

which is a or glucose tolerance test. 

Yeah, exactly. And, and you just, you kind of scratch your head and you say, well, why is this not being talked about when we have this massive, massive issue? And that’s why we’ve actually gotten great interest from, um, countries around the world, or even in like places like Saudi Arabia or UAE, who have higher diabetic rates than the U S believe it or not, which is hard to fathom, but they have this very high or keen interest on testosterone therapy. 

Is testosterone therapy is Kaiser trucks available outside the U S.

So we, we are available in the UK under early access programs. We have, so early access programs are effectively like name patients, so single patients, so say your doctor is aware of Kaiser trucks and he says, this is the best he or she says, this is the best solution for you. They can, they can get access to it. Right. So it’s, it’s, it’s, I guess similar to an approval, but there is access. It’s actually already, we’ve already applied for approval. So that’s underway anyway. So there will be a full approval likely in the United Kingdom. 

We have approved, we’ve applied for approval in Canada already. And then we’re looking at these other countries that, that again, we’ve received strong interest for and we know 

and it’s Kaiser tracks, the only oral, uh, available of its kind. 

So in the U S there, there are two other products, 

but they require a lot of, they require, I think double the dosing. 

So the dose, so the bioavailability, it has 

to be with a fatty meal, which I don’t really want patients on multiple high fat meals. Correct. So yeah, I think they have their own dosing issues, if you will. 

And then again, it comes down to access. I mean, that’s what I’ve seen. I mean, so that’s, that’s what I’ve seen. I’ve seen, um, barriers to entry in two ways. Number one, the absorption for other forms of oral testosterone require a high fat meal, at least 50 grams of fat multiple times a day. So that’s, that’s too high because then it kind of crowds out for other nutrients, especially dietary protein and then access. So it’s not necessarily easy to 

cost over a thousand bucks a month for us. I mean, that’s insane. Exactly. I mean, it’s insane. You’re not going to get coverage or again, 

you’re not going to get coverage. 

And, uh, I can’t ask patients to spend over a thousand dollars a month. 

Exactly. Exactly. That’s when again, you say, okay, you’ll have to use an injection, which is, which is fair and fine. But so we have these other things, but again, frankly. For us, we think the market is so large. Uh, there’s just, this is just a massive problem. So we want, you know, the awareness to grow and I’m, I want everybody to, to, to do well in that sense. Uh, but I think we

just have developed, yeah. What, what should be the standard of care for those multiple reasons? 

What do you, where do you want to see it going? So you want, obviously you have the testosterone project where you want there to be patient advocacy. You want testosterone. De-schedulized. I totally agree with all of that. You want there to be more research on women in five years from now. Where do you want Kaiser tracks to be? 

So I think I, and I want it to lead with the science, right? I think in five years, in five years, if we are successful with that science and education, um, you could see 10 million men in the U S upon Kaiser tracks, um, and, and more globally. But, but what you’re going to see is actually, I love to over time show some of the curves that we have around metabolic disease and, and I love to start correcting them right through, through not just Kaiser tracks, but also this, this mindset of foundational health, right? Or preventive health. And I love to start correcting those curves and, and that to me will be, you know, uh, 

tremendous, tremendous success. 

It’s so meaningful. Well, uh, shalyn shaw, CEO of Marius pharmaceuticals, this, I’m hoping that you will be willing to come back on when you get some of these papers, uh, published and out what I, what you are doing, I think is tremendous. I think number one, you offer a solution. You offer a solution to a healthcare crisis. It is very commonly talked about this obesity epidemic. It is, you know, very commonly discussed cardiovascular disease and Alzheimer’s disease, there are two, in my opinion, there are two core problems. This is the problem with metabolism and muscle and feeding into that, whether it’s the chicken or the egg is this problem with hormones. 

And if we can combine the two, which I think Kaiser tracks makes things very accessible and you guys are so dedicated to education and science that I’m, I’m so grateful. So thank you so much for coming on. 

Thank you so much. I’ll leave there. Your listeners with a bit of a cliffhanger because you mentioned Alzheimer’s. And, and so the research actually will show testosterone deficiency will lead to an increase in towel proteins and towel proteins are one of the best indicators we have to the development of Alzheimer’s beyond, you know, obviously the genetic typing and so forth. So this is some area that we are also going to pursue. So I’ll leave that as a cliffhanger because we’re going to get into it. And hopefully by the next time I’m on, we have something to share. 

Thank you. Thank you so much.

Appreciate it. Thanks for having me on.