Testosterone Therapy: History and Challenges

This chapter explores the evolution of testosterone therapy, focusing on the development of oral formulations and the transition to injectables due to liver toxicity issues. It addresses the misconceptions surrounding testosterone, its societal perception, and the challenges faced in achieving FDA approval and proper clinical use. The chapter emphasizes the need for better education and understanding of testosterone's benefits, while navigating the complexities of its regulation as a controlled substance.

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Testosterone Matters for Everyone

In this episode of The Dr. Gabrielle Lyon Show, Dr. Lyon sits down with Shalin Shah, CEO of Marius Pharmaceuticals, to explore the science, benefits, and future of testosterone therapy. Shalin has been a driving force behind bringing Kyzatrex, an FDA-approved oral testosterone, to market—making testosterone therapy more accessible and effective for both men and women. From breaking down misconceptions to advocating for better access to hormone therapy, this conversation sheds light on how testosterone plays a crucial role in overall health and wellness.

Shalin shares his journey, discussing how his background in investments and his drive to bring valuable but overlooked health solutions to the mainstream led him to develop Kyzatrex. They dive into the challenges he faced in bringing this groundbreaking therapy to market, and how Marius Pharmaceuticals is striving to change the narrative around testosterone through education and advocacy.

We dive into:

The common myths about testosterone and its true role in health
Why oral testosterone is a game-changer, providing a convenient and safe alternative to injections
The importance of testosterone for women’s health, from muscle mass to mood and cognitive function
How testosterone therapy can positively impact mental health and metabolic conditions, including diabetes
The mission behind The Testosterone Project and efforts to make testosterone testing standard practice

Tune in to hear Shalin’s insights into the future of hormone therapy and the steps his team is taking to improve access and education around testosterone. This episode is a must-listen for anyone interested in health optimization, longevity, or understanding how testosterone therapy can impact overall quality of life.

Who is Shalin Shah?

Shalin Shah is a distinguished leader in the field of metabolic health, specializing in testosterone replacement therapy. As the Chief Executive Officer of Marius Pharmaceuticals, he was instrumental in the development and FDA approval of KYZATREX® (testosterone undecanoate) CIII Capsules, an oral testosterone treatment for adult men with low or no testosterone levels due to certain medical conditions.

With a global investment background, Shalin transitioned into healthcare with a mission to revolutionize the industry through metabolic health. His leadership at Marius Pharmaceuticals is marked by innovative strategies that prioritize consumer access and education. Under his guidance, KYZATREX has been launched via consumer-focused channels that include preeminent national healthcare institutions, private-equity backed medical practices, and national telemedicine platforms.

Shalin’s expertise extends beyond corporate leadership; he is an influential voice in longevity medicine and an advocate for reevaluating testosterone medication regulations. His efforts aim to reshape public perception and education on testosterone therapy and its significance for global health. He believes that oral testosterone replacement therapy has created a much-awaited paradigm shift which is critical for addressing the worldwide men’s (and women’s) health crisis, marked by declining testosterone levels and lower life expectancies. His message is that testosterone replacement therapy is not just about adding years to life, but also about adding life to years.

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Read More -

A Phase III, Single-Arm, 6-month Trial of a Wide-Dose range Oral Testosterone Undecanoate Product - https://journals.sagepub.com/doi/full/10.1177/17562872241241864?af=R&ai=1gvoi&mi=3ricys
The Effect of Testosterone Supplementation on Depression Symptoms in Hypogonadal Men - https://tandfonline.com/doi/full/10.3109/13685538.2011.606513
Testosterone Treatment to Prevent or Revert Type 2 Diabetes in Men - https://pubmed.ncbi.nlm.nih.gov/33338415/
Cardiovascular Safety of Testosterone-Replacement Therapy: https://nejm.org/doi/full/10.1056/NEJMoa2215025

This episode is brought to you by:

Marius Pharmaceuticals - Discover more about accessible testosterone therapy options at Marius Pharmaceuticals. - https://mariuspharma.com

Follow Shalin Shah -

- Instagram: @themetabolicceo

- LinkedIn: ShalinShah3

- X: @_ShalinShah

Follow Marius Pharmaceuticals-

- Website: https://mariuspharma.com

- Instagram: @mariuspharmaceuticals

- LinkedIn: Marius Pharmaceuticals

Check out Kyzatrex -

- Website: www.kyzatrex.com