A (8:58)

Thanks for having me, Amy. Yeah, real pleasure to be here and excited to dive into the conversation and like you said, just frankly, kind of share more. Right. For both patients and practitioners.

B (9:07)

Exactly. So, as I said in the intro, you are the CEO of Merit's Pharmaceuticals and came out with a brand new oral form of testosterone that we're going to be unpacking today. But before we get into that, specifically before we get into Kaisertrex, I want to talk about testosterone in general and how important it is for both sexes. Like I said in the beginning, I also find it important when my audience hears it from someone other than me, when I can actually bring on an expert to say, like, see, he's saying the same thing that I say. So I'm going to start there. I'm going to start there. Trt. When did testosterone replacement therapy even begin in the United States? When do we start using this on men? And when do we start recognizing that, hey, this hormone called testosterone really starts to drop after a man turns 40?

A (10:00)

It's been a bit of a. I'll call it tidal wave to a certain degree, I think really in earnest starting in the 80s. A lot of practitioners back then still, much like today, were apprehensive and it was small. And we've had our ups and downs. Right. There was a growing use in the 80s to a certain degree. Late that decade, you had the Olympic scandals and that sort of set testosterone back because Congress actually made it a controlled substance. Right. The only hormone to be. So frankly, doesn't make any sense, but that's added A lot to this stigma. Then you saw some decline in the 90s before it started picking up again. Early 2000, saw some really good research around testosterone. And it's linked to diabetes, right? Or testosterone deficiency, and the link to diabetes. And that continued to grow until in 1314, there were some faulty studies around testosterone and cardiovascular risk. And that set the field back quite a bit. And that was actually quite a significant blow because it was just unfounded and it was terrible. Research that led to it, similar to the WHI has really come full circle and everyone is talking about. There was a great panel last week, two weeks ago, from the fda. So testosterone has been along the way, but underlying this whole, let's call it patient movement or whatnot, right. The research, the good research has been so significant, and it's been across the board as we're talking about testosterone being a metabolic hormone, whether that is related to the neuro side, so brain function or cardiovascular function, bone, muscle, naturally, yes, your libido. And the list just keeps going, right? And it goes even deeper to cellular levels. So, you know, that research is significant and volumeless to. To a certain degree that patients can dive into. But I think if we look at where we are today in 2025, we're finally getting this back on track. Practitioners like yourself that are out there educating. So I feel pretty good about what that means for patients for the next five, 10 years. And this what I call a bit of a hormone renaissance that is starting to bloom, if you will.

B (12:02)

And I love that. I love hormone renaissance because you can feel it. With the new focus on menopause per menopause, with many experts coming out talking about that and it becoming more mainstream. Just like you referenced the WHI initiative, the Women's Health Initiative study that really, I mean, set us way, way back as it ripped hormones out of women's hands left and right and put the fear of God into doctors prescribing them. Now we have that information of the downsides of that study, as the authors have come out and said so themselves. So we are starting to see this shift, and I love it. But just like we're focused on perimenopause, menopause and estrogen and progesterone, I always feel like testosterone gets left behind a little bit. And even with the experts talking about menopause, they focus so much on the female hormones that I feel that women almost get the message themselves that testosterone isn't that important and isn't as important as estrogen and progesterone. So you had Mentioned a few of the benefits. Can we go a little bit deeper and expand on those you mentioned? Even protection against bone, obviously calling it the get shit done hormone. There's the motivation factor, there's that drive, there's energy, body composition, what else?

A (13:14)

So think about, I mean, so let's even talk about the drive, the get you done aspect. Right? So if you look at the flip side for testosterone deficiency, there was a really good study that was done about a thousand patients. This was male for the listeners. There's no reason to segment male versus female in the sense that testosterone, it works across the body in similar ways, right? Obviously, yes, in different amounts. And certain aspects of the body may be a little more receptor dense than others, but at large, I think it's fair to say that this works similarly across bodies or sexes rather. But on the sort of the mental bit for testosterone deficiency. Again, thousand patients with low testosterone, 92,7% reported depressive symptoms and of that 20% were major depressive symptoms. And this is pre therapy, post therapy on testosterone replacement therapy. That 20% of major depressive symptoms went down to 2%. Massive delta. Right. So we talk a lot about getting in an upward spiral. I'm a big believer in a lot of the fundamentals, right? Whether that is exercise, whether that's sleep, whether that's nutrition, stress management. Right. But if you are in this negative vortex, I mean, there are some weeks that are. But even for me it's hard to get all those things done. Right. So if you're in a negative vortex, there's no way in the world you're going to accomplish these fundamentals. So it's kind of this chicken and the egg thing. What are you going to help this person do? Enable them so they can make the changes that they need. A lot of them are lifestyle, right. I think there's this problem of testosterone deficiency in both sexes have occurred for different reasons. A good portion on the male side is lifestyle. It is our sleep, it is our stress levels. Can you fix all of these? No. The environmental toxins are a tough one. Right. That's going to be tough to weed out, at least in the short term. So you want to still give yourself the best shot that you can at improving these things. And I think testosterone kind of being a foundational, the next foundational level beyond the fundamentals is certainly where it sits. And yeah, happy to get into whether that's bone, muscle. Right. You want to be muscle is an endocrine hormone itself. Right. So it's excreting these processes across the body. If you don't have adequate muscle, it's not going to function properly. Right. So cardiovascular endothelial linings. Right. People don't think about cardiovascular disease. So I think the easiest way, honestly, to put it for those thinking about, okay, hey, how big of a problem is testosterone deficiency and how important is it? To me, large scale studies link testosterone deficiency with all cause mortality. Higher. All cause mortality. So what does that mean? You will die sooner if you have testosterone deficiency than you would otherwise.

B (15:54)

And that's because that low testosterone is linked to the diseases that can come from having low. So having low testosterone directly isn't going to kill you. It's because that low t is going to increase your risk of type 2.

A (16:08)

Diabetes, cardiovascular disease, dementia, even, and even cancer. Right. Four Horsemen, the biggest diseases that are talked about in the longevity space and just general health at large. Testosterone has a link to all of them.

B (16:21)

It does. There is that direct link with testosterone and cancer. I, I interviewed a functional oncologist on the show, and she actually gave the story of a patient of hers who was basically stage four, given six months to live, and she thought, well, what the hell, I'm just gonna jack his testosterone up and we'll see what happens. To give him quality of life. Because he had all of the, what I'll call the first buc of those noticeable symptoms, the erectile dysfunction, the belly fat, the fatigue, the brain fog, the cognition, the depression. Of course, he was dealing with a cancer diagnosis as well. She gives him testosterone, ends his life by a few years. So, yes, there absolutely is that correlation with cancer. And like you said, all cause mortality. Now, you had mentioned cardiovascular. So now I want to go to some of the myths out there floating around of how testosterone is bad, and I'll start with a story. So my husband, of course, I tested him when we first started dating. I'm like, honey, let's check your testosterone levels. Right?

A (17:19)

It's greener.

B (17:21)

Yeah. This is a requirement for dating. You need to have adequate testosterone levels. And he was low. So we started him on injectable testosterone sibunate, which we'll get into later in this conversation. The different forms, but. And the pros and cons of them. One of his doctors, not in my practice outside his pcp, basically said that afib that you're having, that little bit of a heart palp, that's because of the testosterone. So it scared the bejesus out of him. And he's starting to second guess his TRT and like, no, honey, that's not it. At all testosterone is going to protect your muscle. So can we talk about the cardiovascular myth out there? And let's bring in the prostate too, and PSA levels and prostate cancer.

A (18:04)

Yeah. So these are two of the largest myths when it comes to trt. And as we stand today, they, through research, right, large scale clinical trials, they have actually been put to bed. Right. So Traverse is the best place to. And even pre traverse it was known. But I think if anybody really wants to sort of fight that battle, then you just point to Traverse and that's unequivocally demonstrating that there is no cardiovascular risk with testosterone therapy and there is no prostate cancer risk with testosterone therapy. And just for the listeners, right, this was a 5000 patient double blinded, placebo controlled trial that was effectively mandated by the FDA back in 2014. Probably cost, I don't know, upwards of 3, $400 million to complete by industry. And it finally read out in the New England Journal of Medicine in June of 2023. So it was actually just poor faulty studies that, that led to this overblown concern. And actually an interesting stat I'll share is we surveyed primary care not too long ago, only a few months ago. Right. So we're still talking two years post release of this study and I think the number was 84% still had not heard of traverse and the data. So it's very tough for patients to then go in and have to sort of fight for their right, if you think about it for TRT and then they get second guessed and they're asking around and that leads to inaction, which is only detrimental. So, yeah, actually I think you'll see a lot of the conversation actually shift to how this is cardio protective. Same thing on the cancer side. There was an interesting study done two, three years ago and it looked at this was actually colorectal cancer, TRT and the rates were actually 25% lower on testosterone. So it's a long process of reeducating both that patient and provider. But I think there's a significant wind that I feel out there that that's helping.

B (19:57)

Oh, huge. Yeah. I do think we're starting to see the winds of change with this, but we need to go a little bit faster. So you touched on the myths. I think another barrier for the consumer, the patient, to obtain proper TRT therapy is that it's a scheduled drug. And so I'm going to throw out my theory, I've said it before, I'm going to throw it out and get your opinion. But my unsupported hypothesis on why testosterone has been placed into a very difficult category. Basically what we mean by scheduled is that a provider has to have a DEA license to prescribe testosterone. And think of it, it's in the same categories as opioids.

A (20:37)

If I'm not wrong, it's just one category, but often get looped together. So opioids are scheduled too, but still they, some, a lot of places treat them the same. So the logistical hurdles, there's no difference.

B (20:48)

Right. And you have to have that DEA license to prescribe, so making it very difficult. My theory is that because testosterone can help get men and women off of antidepressants, statins, blood pressure medications, sleeping pills, Viagra, Cialis and xyz. Gee, if we make that easy, those pharmaceutical companies take a really big hit if they're not getting, if they're not getting the amount of sales from the statins and the antidepressants, which are two of the most prescribed medications out there. So that's my theory. I don't know if you have a different thought on this, but that's my.

A (21:24)

It's in line. Mine is in line as well. Right. I think it's, it is a little, it's called to be too good to be true and it affects a lot of the research. Like I mentioned, even the statins in the depressants are in some sense that that low hanging fruit. Imagine we talk about cancer. That is a sort of a holy grail of research that you're then going after. And I mean, what's our ultimate goal as a society? Right. We want to prevent disease and cure disease. So it's a little disconcerting that that hasn't gotten a little bit more attention and support, if you will. But I think there's definitely some underlying truth to your hypothesis.

B (21:57)

Well, and then from the insurance company standpoint, I also heard you say on another show that it's easier to get reimbursed for a chronic disease drug than for a mass market drug like testosterone. Is that true?

A (22:11)

Yeah. So most of the drugs that are reimbursed today are these extremely high priced specialty drugs that are coming from the big pharma players like you're mentioning. But for a mass market drug like an oral testosterone, you would think they're and honestly affordable too. Right. There shouldn't be any hurdles. So it's kind of a backward system because that could then in turn decrease healthcare spending. So. Right. Like all those things that you mentioned, all those conditions, if you're able to help them. Look, not everybody is going to go through and it's impossible. It's hard for us to do it too. Run every study to prove out every indication and whatnot. But when you have enough real world evidence that is pointing in a certain direction, just like the FDA did two weeks ago when FDA commissioner came out and said hey, hormone therapy for females is important for all of these reasons. That's not on a label actually, but he understands the research that's been done and the role that they play in the human body. So he's able to make that statement as a sci, as a physician scientist. Right. So I think for testosterone a lot of the same position can be taken very publicly and you go to payers, this can help their bottom lines. If you look at, if they looked out beyond two years. Right. That's the problem. They're only looking out because you're going to switch your job most likely and I'm not going to cover you in two, three years. So why bother? But if they took a more long term view then you'd save health care costs, significant healthcare costs by something as basic as testosterone therapy.

B (23:38)

Oh my gosh. Absolutely. Now you are, you and your team, you have a nonprofit that you're actually fighting to get it rescheduled. Is that true?

A (23:48)

Yes, that's correct, yes. And the testosterone project, descheduling is a top priority for us and that's where we've had a lot of conversations around this. Granted the new administration is, some of the departments are in a bit of flux and so forth. So that's really where we're kind of pending if you will. But yeah, I think the case is very strong. You haven't seen abuse in this class. Oral testosterone is even harder to abuse. Right. Because you're not going directly into the bloodstream with supraphysiological levels. So I think there's even a better case there unbiasedly. But ultimately it's about access and stigma. So how do we remove this for patients and providers? So we want a healthier population.

B (24:25)

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A (26:00)

Revolution, right? That's really what we need. I think if we can have. That's what we need to sort of bring to Washington's front door. And that's when they listen.

B (26:08)

Yeah, exactly. Just keep knocking. Right, exactly. So yeah, you had mentioned oral, oral testosterone. That's what Kaisertrex is. So I want to go deeper into that. But before we do, let's talk about the different forms out there that are more common for men and women and then even the pros and cons around those. So we'll start with the men. So for men, yeah, there's gel, which I gotta tell you, I've never seen it really work well for men. I mean nine times outta ten they're not compliant with it, they're not rubbing it improperly. And then there's the downsides of transference from if a man puts on a gel and uses a towel and then the woman grabs the towel or your child grabs the towel or what if you don't wash your hands good enough and you touch your dog oil. I mean there's all of these things. And we can also say that for the compounded cream that we use for women and there's some downsides with the cream that I'm very vocal about. It does push up DHT more so than other forms. So I tend to, in our practice we use injectable for nine times out of 10, male and female will use Injectable. And then of course, there's the different esters of the injectable, there's cypionate and they propionate with different half lives. So now comes along Kaisertrex, and it's oral. And in my past, coming from the bodybuilding world, oral testosterone or the oral forms of anabolic drugs, we'll say that we all knew, like, ooh, that guy's gonna pound his liver because he's taking that oral. But that's not the case with Kaisertrex. So I wanna really unpack all the benefits of oral dosing of testosterone from using Kaisertrex. Not just any old oral form that you get on the black market from the guy at the gym, but using Kaiserrex and oral form versus those other delivery methods.

A (27:46)

Sure. So, yeah, I think the first thing, like you mentioned is this whole historical past around liver toxicity. And that's still a common misconception to this day, even when we start our conversations around Trex in that sense, and just precursor. Right. Kaiserrex is. Today, it's only indicated for men with low or no testosterone due to certain medical conditions. Right. Whether that's pituitary issues, test testy issues and so forth. So we are working on a number of changes there, but that's how it stands today. Lymphatic absorption. So Kyotrex is absorbed through the small intestine. Right. So we've figured out a way here to bypass the liver uptake through the small intestine and into the bloodstream. And so we see no liver toxicity through any of our trials or data. And I think that's a huge breakthrough. Right. Because at the end of the day, we understood one, we understand how important a metabolic hormone, testosterone, is. And if we have this, let's call it metabolic crisis or testosterone deficiency crisis, how do you solve that at scale? Right. Like injectables like you say that you use, 9 out of 10 are very tried and true and reliable. But we know to reach the massive population that needs this, unfortunately, not everyone's going to inject themselves. Right. We live in a world that, yes, people are comfortable taking capsules or pills. You already likely have a pill box with your other supplements, so you're going to add it to your routine and it's going to be seamless. Right. So I think there's a convenience factor that goes sort of without saying with that, but to your first point is that this is not liver toxic. So patients and practitioners alike, they don't need to be worried about that. Right. You do have to take it with food helps activate the lymphatics, and then it will go through that system. But you do not have to worry about historical safety issue. That's one big thing. The other big thing here is what we see now is that because this is taken daily, you're effectively mimicking your natural circadian rhythm. Right. Hormones are produced every day in the body. When you're sleeping, you're producing your hormones, and that's why I think they're so messed up today, because our sleep is awful. But you're producing overnight and then peaking in the morning and then going down throughout the day. So Kaisertrex is the closest product to mimic that natural circadian rhythm. And you're getting a physiological dose on a daily basis. And I think that's a real important point. And we'll talk about that versus sort of what you see typically in injections. So what it does is then it really mitigates the side effect profile. So some of the things that you typically see with testosterone are elevated hematocrit. And this can be an issue for a number of men that sometimes maybe their dose is a little bit higher, but they're taking it for a couple days at a time. At least you'll see an elevated hematocrit here. In our trials, it was sub 2% of patients had elevated hematocrit. Sub 2%.

B (30:28)

Whoa. Oh, my gosh. I would say we see about 80% in men and women. I have. I have elevated hematocrit and hemoglobin.

A (30:35)

Okay. And it's spanning across both. So sub 2% there, and then that would also resolve from a down titration. Right. So nobody ever left the trial because of that. We have a Kol that published an abstract on their own practice data. They also were only treating with max dose at 400mg bid. And the still, the hematocrit level was very much in line without these excess excursions. So that's an interesting paper as well that's out there, but it's a huge both for providers and patients. Right. Like, providers don't really want to worry about your hematocrit, like, being elevated. Right. Did you go and dump blood? I don't know. Did they have time that week? Like, it's a big ask.

B (31:14)

Well, it is, because I don't have time to go donate blood. And I know I should, and I know my husband should, but we just don't have time. But that can be not a smart thing to do. You really should go and dump.

A (31:25)

Right. But Think about all the patients out there, right, that are floating around that in. In the similar boat. So that's a big thing. Things like excess estrogen conversion, we don't see. Right. And I think a lot of this all stems from physiological dosing.

B (31:39)

Oh, wait, you need to pause on that. That's huge. Now, it was in my list of questions to ask you, but that is huge. So just to explain to the audience, I see this more in men than in women because of the doses that we're giving men. So let's take the injectable, right. Testosterone stipulate, injectable. We're going to dose a man at 200 milligrams per week. Whether he splits it up into microdoses or does once a week dosing, whatever, it's around 200 mix. And with that there's that aromatization to estrogen. So of course, we always test a man's ultra sensitive estradiol. We want it there, but not. We don't want you having zero estrogen. We want some, but we also don't want it high. My husband was. Oh, goodness, I want to say his estradiol was like 185. That was way too high for a dude. So what does he get put on an ostrozole, an aromatase inhibitor to block that aromatization from testosterone to estrogen. So you're saying. And the AIs, the aromatase inhibitors, they come with their own kind of side effects. They can drop a man's E too low. You just get side effects with the AI as well. So it's kind of like you're treating. Yeah, exactly, exactly. So Kaiser Tracks does not aromatize or aromatizes very, very little.

A (32:52)

You do not see. Unless you have a predisposition, Right. To aromatization, which a couple percent of guys do. Right. We do not see an excess at an aggregate sort of mean level across our data. And anecdotally, in a lot of my discussions with clinicians, Right. Which I'm having every day, AIs are not part of a standard treatment protocol with, with Kaiser Tracks. So I think that's really, really nice from just, I mean, one. Yeah. One less thing to manage and the side effect profile, you need some estrogen. Right. Like, I think that's been a problem even with some of the folks on Clomid. Right. Like, the numbers look really good, but some other blocking mechanisms happening there. And then they're overly moody and sensitive and just all hell kind of breaks loose on half of those patients. Right. So that's a big one that we have not seen. We don't see it physiological doses, daily doses, we don't see testicular atrophy. LH and FSH is not dropping to zero. Undetectable levels is what generally happens. That's not what's occurring here.

B (33:47)

So that's going to also come back and protect fertility in men because we do. I mean, let's face it, we have a couple men right now as patients that they're in their 20s and they have that hypogonadism that it just. Their T levels are coming in at 185. The one gentleman has a T level of 250. I mean just really, really low. They need testosterone replacement therapy, period, end of story. But in doing so, they are rolling the dice with their fertility.

A (34:17)

So yeah, it's a really interesting concept. Not saying Kaiser effects maintains your fertility, but it does not lead to total suppression of the LH and fsh.

B (34:25)

Right.

A (34:25)

And we are running a pilot study or actually one of our KOLs, Dr. Mohit Kher out of Baylor is running a fertility study. He's looking at spermatogenesis in patients, young male patients. And I believe he's due for another update on the study. But the last update in the fall, 80% of the patients reported no significant decline in sperm counts on drugs. So I think this is a really, really interesting sort of paradigm because the fertility crisis for young males is massive and it's partly driven in fact bilo testosterone. Right. But the normal course of therapy would not be the solution. Right. You can't give them high doses of testosterone to return that fertility. But what if you could not affect it? One or two, maybe there is a case for rising intra testicular levels by sort of pulsing exogenous testosterone.

B (35:18)

And that would tie back then to that. You talked about a circadian rhythm of testosterone. So if we keep that nice and steady, which I think we try to do with injectables when we have men microdose through the week. So some men, some men like my husband are non compliant. You got just got to do once a week. But other men can actually do microdoses of, let's say testimony throughout the week to kind of have that pulsatile effect of testosterone.

A (35:44)

Correct.

B (35:45)

With Kaiser tracks, you're getting that hands down with, with the injectable. It's kind of a crapshoot. You could still get that, that spike even from a microdose, even from that microdose that you take one day every other day.

A (35:58)

Correct.

B (35:58)

And then you get that crash. But With Kaisertrex, it's. It just keeps you steady.

A (36:02)

Yeah. You're just pulling in that curve. Can you achieve it if you were injecting yourself every day? But it goes back to my point around scale, right. If you got 25 million hypogonadal men, we can't expect them to inject every day. It's just not great.

B (36:15)

You're not gonna.

A (36:16)

So this can solve that.

B (36:17)

Well, I love it because I actually asked my husband, I'm like, okay, I know that you're non compliant with most of the things that I tell you to do. I said, today I'm interviewing Challenge Shaw about Kaiserrex, but you'd have to take it twice a day. Would you actually do that? He's like, well, yeah, for something like this, I would.

A (36:34)

Right.

B (36:34)

This is actually the one time that my non compliant husband would be compliant because of the benefits.

A (36:39)

The motivation would be there, right? Yeah, exactly. So I think it kind of introduced like, yeah, nobody wants to take their statin, right. They're like, that's not fun. But I think when you see the benefits, the patient motivation to be compliant goes way up.

B (36:51)

Yeah, yeah, absolutely. Now I'm going to pull this back to the ladies. So ladies listening, hold on, we're going to tie it back to you, but I have to ask another Mayo question in regards to psa, do we, do you see any. We'll say decrease in the incidence of increased PSA that we can see with normal testosterone therapy.

A (37:12)

So the, yeah, so the average PSA increase in our data is about 0.15. So minuscule increase in PSA. And this goes back to like, you're just not blitzing the system with too much testosterone. Right. You're giving what you need for that daily. Overall, there should be some rise in psa. Right. So if you're testosterone deficient, like the PSA actually needs some of that to be active. So even any rise, you're actually just restoring yourself to where you would or should be. So I don't think it's alarming at large in that sense. But yeah, so you don't see an over activity stimulation there and that rises minimal.

B (37:50)

I mean, with traditional TRT we can see it rise 5 points. And then of course, if you're working with a conventional doctor, he or she is going to set.

A (37:59)

Yep. Sets off all the bells. And you're not going to be on that too much longer?

B (38:03)

No, no, they're going to pull that and then they're going to biopsy your prostate. So not fun.

A (38:07)

Not fun. Yes. So you see, I think, like, that's the interesting bit here now, like, you see a significant safety paradigm shift that allows patients to have these conversations, providers to have these conversations. And it really introduces a concept of like, let's try it and see how you do. Right. Because again, symptoms are the reasons that most people are presenting. I think there's still a conversation for, and we'll get there, where there's underlying metabolic health that you need to treat and be aware of, whether that's fasting insulin levels or inflammation in the body. Right. That can be treated through this mechanism. But I am fully conscious of that's a conversation like, that's evolving and still has to get there. Right. Let's start here. But yeah, those safety things. And one thing I do want to mention on the efficacy side too, and I understand it because of historical reasons and you kind of have this bit of the bodybuilding world and whatnot. A lot of people just said oral testosterone doesn't work. Right. They just think, well, you need to get ultra high levels. So I think there's two things that it's important for people to really understand. One is still serum testosterone levels. Right? This is the amount of testosterone that's floating in your bloodstream. Remember, the testosterone is binding to receptors and activating them. Right. So there's a lot of scientific case for saying that activation is really what matters. Your circulating T level is a proxy for that. But that doesn't really tell you that everything's bound and active. Right. That matters. So I think it's important for people to kind of start to get that concept going. But what helps that is that Kaisertrex actually decreases a protein called SHBG and increases free testosterone. And that that increase on paper is around two times of an increase for free testosterone. And some of our published papers and posters and whatnot have shown a significantly higher increase, 2 to 4 times increase in free T. So you're getting a physiological T level mid range. Right. Which conventional says, well, that's okay, but your free tea could be four times higher and absolutely crushing it if you want to compare it to any other modality.

B (40:10)

Okay, so this is huge with shbg. I talk about this a lot. So just to kind of give a refresher to the audience, sex hormone binding globulin. I always give the analogy of a train and your hormones have to jump on this train to be delivered to the receptor sites where they want to go to do their job in your body. Sometimes that train gets really sticky and the hormones jump on and then they can't get off. Usually we. I always tell my audience too, and my patients alike that have elevated shbg. Look, sometimes the very things you're doing for your health, like going low carb, like taking T3, taking estradiol, hormone replacement, taking testosterone, those are the things that can ironically increase your sex hormone binding globulin. So you don't want to throw the baby out with the bathwater. You want to be able to treat that SHBG and bring it down. Now, my fixer line, I have SHBG fixer. And sometimes, you know, I'm telling people, listen, you're just going to take that to put a cap on that SHBG so it doesn't go above the 150 that you're already at. Ultimately, I'd love to see it down around like a 60 or a 70 for both male and female. 60 to 80 is my sweet spot. So when it starts to go above that, it's like, oh, you're going to bind hormones. Now what do we do? So you're saying that Kaisertrex can actually be another tool in our toolbox to lower shbg. That's huge.

A (41:33)

Yep. Like you say, a lot of folks are running around with high elevated levels today. And whether that is a function of age, some of the other hormones, like their body's compensating. Right. And raising SHBG to match this influx of endogenous or exogenous to, I mean, hormones. Right. So, yeah, now you have another tool to look at the overall picture. Right. A lot of people have these normal T levels, high SHPGs and low free T levels. I see that from a lot of our providers day in and day out. And I'm just like, what do we do? So in some sense, you don't need the T a lot higher. You just really need to free up the free testosterone and work on that ratio. And if you can do that. Bingo.

B (42:12)

Yeah. And actually, so this is the perfect bridge. I find in my practice that women have higher SHBG levels in general than men and most likely is due to the estrogen replacement or just we have more estrogen in general. Some women are coming off birth control years, decades under control.

A (42:28)

Huge culprit in this, in this equation.

B (42:31)

Yeah, absolutely. It's huge. It's huge. So for my ladies, Kaiserrex is not yet FDA approved, but of course, when you're working with kind of out of the box thinking practitioners, we can still use it with the ladies. Right. In a much lower dose.

A (42:45)

Right. So yeah, like Kaiser is not approved for females. We are looking at these programs. Our goal is to bring a female approved product to market hopefully in a shorter timeframe than what is typical given agency's view on hormone replacement therapy at this point, based on our initial understanding of where the program needs to be. Typically a female dose is one tenth of a male dose. Right. So two things. I don't think it's that hard to figure out what would be an appropriate female dose for our program. Right. And we'll have a couple options that we'll run through our trials so you can titrate appropriately. But yet for this general population it's been highly neglected and a missing part of the puzzle. So I can't, I mean you'll, you'll see this firsthand, right? Like how many females come back after being put on testosterone therapy? How many come back and don't say that they're feeling better. Right. I mean it's pretty much night and day and often probably the, for seemingly so the biggest difference maker of the female hormones, whether it's progesterone, estrogen and just in that feeling. Right. And sort of the vigor that they come back with. So I think it's as simple as female testosterone deficiency. It doesn't need to be hypersexual disorder, it doesn't need to be osteoporosis, it needs to be female hypogonadism.

B (43:59)

It does, it really does. So right now, just for the listeners to understand, right now, the only way a woman can get approved for, we'll say approved for testosterone replacement therapy is if she has the hyposexual disorder or osteoporosis. That's it. It doesn't matter if she comes in and reports to her general PCP that hey doc, I've lost a lot of muscle, I have no libido whatsoever, I have brain fog, I have no motivation and my testosterone is a 5. That's not enough for her to actually get TRT. She actually has to be diagnosed with hyposexual disorder. Basically.

A (44:36)

Yeah. That's the only thing that sort of sanctioned guidelines today. Right. And there's only four countries in the world with still approve female products. You know, the USA is, there are probably by our estimates at least a million females that are on testosterone replacement in this country. And I think there's a lot through pellets, some on injectables and then these, the creams. But think about how revolutionary an oral option would be for that patient population.

B (45:01)

Oh my goodness, I'm So happy you mentioned pellets because there's the complete opposite of what Kaiser Tracks does. So pellets, Jack, a female's testosterone, I have seen it as high as 900.

A (45:12)

Wow.

B (45:12)

When she is tested one month after pellet insertion because she's at that peak. And I know all the pellet literature out there is like, no, no. It's dispersed evenly throughout those four months that it's in. No, it's not. No, it's not. You get this bolus dose and that's where you get the hair loss and that's where you get all the androgenic symptoms that are irreversible because you can't take the pellet out. So if you're on an oral like Kaiser Tracks and you. And that's going to be my next question to you. But if, if you're on an oral like Kaiser, you can adjust the dose. So let's talk about those androgenic effects. And I mean, this applies to male and female. Have you seen in your studies any reduction of those androgenic symptoms that can really hit, especially a woman can hit her pretty hard when she starts crt.

A (45:57)

Yeah. So in our studies, these are all male based, but we have not really seen that. Right. We have not seen the hair loss. The deepening of voice is obviously a big concern with females. I think females are concerned with kind of looking like Arnold Schwarzenegger. Like that's not going to happen. I think most, even peri to postmenopausal women struggle with adding muscle or healthy lean muscle. Right. This is really what is going to help at the end of the day. So metabolically, that whole picture is going to be improving.

B (46:26)

I love that. I love that. So for a man you mentioned earlier, usually 400mg twice a day is on average. So I think it's important for us to say this out loud for anyone who is on TRT because they're going to hear 400 twice a day, I take 200 a week. How does that equate? And then for women. So let's say we went down to. I know Kaiserrex comes in 100 milligram capsules. So for women, if we went to 100 milligrams again, they're going to freak out and go, wait a minute, I'm on 10 milligrams a week of tassipionate. If I take a hundred a day, won't I turn into a dude? So how is that different from the injectable dosing to the oral Kaisertrex Dosing. Right.

A (47:06)

So there's no perfect conversion chart, but since it's oral, we have to look at what the overall bioavailability is. Right. So you're gonna really be, at the end of the day, it's a couple percent that's gonna end up in the bloodstream versus an injectable. It's pretty much a hundred percent is going into the bloodstream. So very different ultimate equation there. And you'll see things like this in other classes too. Right. As the oral GLP1s come out, your patients are going to go from this 2 1/2, 5, 10 milligrams a week to 20, 30 milligrams at least daily. That's where actually the studies are. So you'll see a similar sort of transition occur when those products actually go oral. But no, ultimately at the end of the day, you have to look at what is then the circulating blood levels. So you might be taking that 400mg bid, but your blood levels are in physiologic ranges and that's really what counts. So you're not causing extra stress to the liver. There's no liver toxicity and so forth. This is just a bioavailability equation that that's where we dose accordingly.

B (48:03)

Right, Right. Okay. I love this. Now for prescribers, can this be picked up at WalGregreens, called into CVS or does it have to go through, let's say, a special mail order pharmacy? Where can a prescriber send in a prescription for Kaisertrex?

A (48:20)

So prescribers, yeah, we've actually partnered with a number of compounding pharmacies to distribute the drug. Again, they do not make Kaisertrex whatsoever. They have the bottles in stock. Just given that a lot of our sort of prescribing world is used to working with them. So that makes it a lot easier to kind of, for that continuity, we've not gone through CVS's and Walgreens of the world because frankly, that just increases the cost to the patient though Marius launched Kaisertrax as a cash only product for better access. Right. Even though all of us have insurance, they put up every roadblock and hurdle to getting a therapy that's better for you or you want or need, et cetera. So we actually just made it a cash product to make it more accessible, generally in line with where the market is. And people are already used to paying for their hormones, frankly out of pocket. So we have a number of pharmacy partners, they're on the website, you can just prescribe through there where you're generally already writing to or. Yeah, there's mail order options too, where the patient will get a text message saying, hey, your script is ready and you'll just check out and a couple days later you'll have your medication.

B (49:23)

So easy. Well, and to your point, and I've heard you mention the pricing before on other shows. It is absolutely in line, if not less than testosterone, even if you pick it up at CVS or Walgreens and your co pay is easily in the hundreds. And then. Right. Compounding pharmacies. I tell all my patients we're going to be sending this into a compounding pharmacy. Compounding pharmacies do not accept insurance. Period. End of story. So Kaisertrex is going to be less than some of my compounding pharmacy prices. So probably.

A (49:55)

Yeah, yeah, absolutely. Right. I mean, our goal is access at the end of the day because there's 25 million males with this problem, probably 50, 70 million females with this problem, if not more. Maybe it's a little idealistic. Right. We don't want to spend 13 years of R and D and hundreds of millions of dollars of development to then ultimately no one have this thing. Right. Like that doesn't make sense. So a little idealistic, but that's our goal and mission.

B (50:19)

Well, I thank you for that because it's more important to get people feeling good and living their best life than. Yeah, than going through 13 years of R and D. So, okay, so for the consumer and then flip me over to the prescriber. Where should each set population go to find out more information?

A (50:38)

So both should land on kaisertrucks.com k y z a t r e x com. Obviously our patient side of the website will have patient focused resources and where to go. The provider side will have more targeted provider materials and they can be on our site as a provider so patients can find them. They'll find out about the pharmacies and where they can easily send the prescriptions and frankly, just also engage with us. Right. Like, we love talking to clinicians that are exploring this, integrating it deeply into their practice. Want to do more research. Right. Further, let's call it this Metabolic Mission.

B (51:13)

I absolutely love it. We'll put all of that information in the show notes as well so it's easily accessible to you all listening. So Shaolin, thank you so much for coming on and sharing all of this amazing information and just revolutionary treatment for testosterone. I absolutely love it.

A (51:30)

Thanks so much for having me, Amy. It was a real pleasure and look forward to continuing the dialogue.

B (51:34)

And again let us know whatever we can do. Let me know whatever I can do to help you in this mission to get it descheduled and to get women into these studies too.

A (51:45)

So yeah, no, absolutely. There will be more to share upcoming. Absolutely beautiful.

B (51:50)

Thank you once again and thank you all for listening. The information shared on the Thyroid Fixer Podcast is intended solely for informational and educational purposes. It is not a substitute for professional medical advice, diagnosis or treatment. Always consult with your physician or other qualified healthc care provider with any questions you may have regarding a medical condition treatment or before making changes to your healthc care regimen, including medications, supplements or other therapies. Use of the information provided in this podcast does not establish a doctor, patient or client provide provide a relationship between you and the host or between you and any other healthcare professionals featured on the show. Any medical opinions or statements made by guests are their own and do not necessarily reflect those of the host or affiliated parties. Statements regarding dietary supplements or health related products mentioned in this podcast have not been evaluated by the fda. These products are not intended to diagnose, treat, cure or prevent any disease. Some episodes of the Thyroid Fixer Podcast may include sponsorships or affiliate links. The host may receive compensation for discussing or promoting certain products or services. Any such sponsorships or affiliations will be clearly disclosed during the episode. All opinions expressed are those of the host or guests and do not necessarily reflect the views of any sponsors. The inclusion of a product or service does not imply endorsement by any healthcare professional featured on this podcast.