Understanding Testosterone and Muscle Preservation | Shalin Shah

**Dr. Gabrielle Lyon** (0:00)
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, Shalin Shah. He's the CEO for Marius Pharmaceuticals, and he's brought the FDA-approved drug, Kyzatrex, 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 Shalin Shah. This episode has been supported by Marius Pharmaceuticals. Shalin Shah, welcome to the podcast.

**Shalin Shah** (0:56)
Thank you for having me.

**Dr. Gabrielle Lyon** (0:57)
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, and which, by the way, has been instrumental in the development and FDA approval of something called Kyzatrex, which is oral testosterone.

**Shalin Shah** (1:21)
Yep.

**Dr. Gabrielle Lyon** (1:21)
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 at Baylor, which is one of the number one places that one would be able to study andrology, specifically testosterone and other anabolics, who works underneath Dr. Mo Hekera, who, by the way, is a very good friend of yours and who's also doing some of the really pivotal research.

**Shalin Shah** (1:59)
Yep, Mo is a close advisor and friend and has really been helpful in bringing light to, obviously, the therapy and kyzatrex itself.

**Dr. Gabrielle Lyon** (2:06)
Which is amazing. So 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.
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, you know, 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, well, what are my options? And I had never heard about Kyzatrex before or any form of oral, which I assume from what I understand, there are three oral testosterones. 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.

**Shalin Shah** (3:17)
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 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 Kyzatrex 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.

**Dr. Gabrielle Lyon** (3:58)
Can you tell me a little bit about, well, I'm curious as to how you got involved in this, because 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.

**Shalin Shah** (4:14)
Sure. So I have an investment background. I've been doing that all my career.

**Dr. Gabrielle Lyon** (4:19)
And you did your undergrad at Rutgers, by the way. Small world.

**Shalin Shah** (4:23)
Yeah, 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 Kyzatrex was in development since 2009 And this all happened in the RTP area. And that's where Marius is headquartered. So great data. 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 cracked 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.