madman
Super Moderator
Shalin Shah is the CEO of Raleigh, NC-based Marius Pharmaceuticals, the company behind Kyzatrex, an FDA-approved treatment for testosterone deficiency. Since joining Marius in 2017 as Chief Financial Officer and EVP of Strategy, he has played a pivotal role in shaping the company’s commercial and scientific direction.
With 15 years of experience in investment and operational leadership across various industries, he brings a pragmatic, cross-sector approach to pharmaceutical innovation. A former Barclays London executive, Shah is now leading Marius’ efforts to redefine testosterone therapy.
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In an exclusive interview with The American Bazaar, Shah discusses Kyzatrex, the challenges of hormone health, and the future of testosterone treatment.
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The American Bazaar: What inspired Marius Pharma to focus on testosterone therapy, and what gaps in treatment were you aiming to address with Kyzatrex?
Shalin Shah: Testosterone is one of the best barometers of overall health, yet it has been widely misunderstood. Hormone health should be treated as seriously as any other aspect of well-being. Testosterone therapy has been used successfully for nearly a century—including for women during menopause—but its progress was hindered in the 1990s when it was classified as a Schedule III controlled substance. Despite opposition from the FDA, the AMA, and the DEA, this decision was driven by political pressure rather than science. At Marius Pharma, we aim to challenge outdated perceptions, increase awareness, and provide effective, accessible treatment options for those who need them.
----------------
How prevalent is hypogonadism, which is characterized by low testosterone levels, in the United States? Why does it need urgent attention?
An estimated 20 million men between ages 25 and 75 in the U.S. suffer from low testosterone. Despite its high prevalence, hypogonadism often goes undiagnosed and untreated, leading to downstream health consequences such as metabolic disorders, cardiovascular disease, and reduced quality of life. Addressing this condition is crucial for improving overall health outcomes and preventing chronic disease.
-----------
Do you think it is not taken seriously enough by Americans?
No, but that’s largely due to a lack of education on the issue. If people aren’t aware of the health risks associated with low testosterone, how can they take it seriously? Raising awareness and normalizing discussions around hormone health are essential steps in ensuring that men receive the care they need.
-------------
While most doctors prescribe routine cholesterol and sugar level tests for their patients, not many recommend testosterone tests, unless there is a specific condition that warrants the tests. Do you think that should change?
Absolutely. That’s one of the reasons we launched The Testosterone Project (testosteroneproject.com), which advocates for routine testosterone testing. Early detection of hormonal imbalances can significantly improve quality of life, help prevent chronic diseases and reduce long-term healthcare costs.
-------------
Kyzatrex was launched in the United States in October 2022. How successful has it been in the market? Do you have plans to launch it in other parts of the world?
Kyzatrex received FDA approval in July 2022 and has since gained traction, particularly through partnerships with major telehealth retailers like Whole HealthRx by The Vitamin Shoppe, HenryMeds, and Thrive. We also plan to expand internationally and have filed submissions with multiple international agencies.
---------------
Testosterone treatment, it is believed, would help diabetic and cardiovascular patients. Can you elaborate?
Testosterone plays a vital role in both metabolic and cardiovascular health. It acts as an insulin sensitizer, helping to improve glucose metabolism and potentially benefiting men with Type 2 diabetes. Research has shown that testosterone therapy can slow or even reverse atherosclerosis, lower cholesterol levels, and reduce the risk of heart disease in aging men. Studies also indicate that age-related declines in testosterone are associated with an increased risk of cardiovascular disease, while maintaining healthy testosterone levels is linked to better heart function and overall health. Low testosterone in men with congestive heart failure has been associated with poorer outcomes, further underscoring the importance of proper hormone management.
=============
There has been some controversy around testosterone therapy and its potential risks. How does Kyzatrex address safety concerns, and what does the latest research say?
Testosterone therapy carries a Black Box Warning, but the 2023 Traverse Study found that TRT (Testosterone Replacement Therapy) does not increase major cardiovascular risks, such as heart attacks, strokes, or hospitalization for heart failure.
-----------
How does the bioavailability of Kyzatrex compare to injectable or transdermal testosterone treatments?
The important aspect to evaluate in Testosterone treatment is how closely are you mimicking the natural circadian rhythm of the body. Injectables often taken weekly or more, have a hard time accomplishing that. Kyzatrex daily is able to more closely replicate this and thus, we see it evolving into the standard of care.
-------------
What regulatory challenges did you face in bringing Kyzatrex to market, and how did Marius Pharma navigate them?
While not uncommon, the FDA threw a curveball at Marius without real basis and understanding of the issue despite Kyzatrex generating the most compelling efficacy and safety data in the testosterone space. The FDA’s stance jeopardized years of work and over $100 million in investment. Unlike many companies that avoid pushing back against the FDA, we took an unprecedented approach by engaging at all levels of the FDA and openly addressing what we saw as bias against hormone therapy and smaller pharmaceutical companies. This strategy ultimately led to Kyzatrex’s rightful approval, ensuring that patients have access to this much-needed treatment.
-----------
How do you envision the future of testosterone therapy evolving, and what role will Marius Pharma play in shaping it?
The future of testosterone therapy lies in breaking down outdated stigmas and expanding access to treatment. Through The Testosterone Project, we are advocating for routine testosterone testing to improve early diagnosis, expanding awareness of testosterone therapy’s role in women’s health, and pushing for the de-scheduling of testosterone from its current classification as a Schedule III controlled substance. Marius Pharma is committed to driving these changes, ensuring that testosterone therapy is recognized as an essential component of healthcare rather than a controversial topic.
=--------------
What steps are you taking to educate both physicians and patients about the benefits and proper use of Kyzatrex?
We are committed to raising awareness through multiple channels, including educational marketing materials, webinars, and provider training sessions. We also operate ReThink Testosterone, a disease state awareness platform that serves as a resource for both healthcare professionals and patients, helping to debunk myths and provide accurate, science-backed information about testosterone deficiency and treatment options.
---------------
Marius Pharma is competing with some established players in the testosterone therapy market. What differentiates your approach and business strategy?
Unlike competitors that rely on insurance-based models, Kyzatrex is a cash-pay option, eliminating prior authorization headaches and making treatment more accessible and often actually more affordable. This allows patients to start therapy without delays and reduces administrative burdens for healthcare providers.
----------
Are there any upcoming research studies or clinical trials that could further validate or expand the applications of Kyzatrex?
Given the tremendous adoption of GLP1s and the muscle mass loss that occurs, we are starting a study with Kyzatrex and Semaglutide. This could have tremendous positive ramifications for a large portion of the U.S. population. We are also currently conducting a study with Dr. Mohit Khera to evaluate the effects of Kyzatrex on male fertility, specifically its impact on LH and FSH levels. This research could provide critical insights into how oral testosterone therapy fits within broader fertility considerations for men.
With 15 years of experience in investment and operational leadership across various industries, he brings a pragmatic, cross-sector approach to pharmaceutical innovation. A former Barclays London executive, Shah is now leading Marius’ efforts to redefine testosterone therapy.
----------4
In an exclusive interview with The American Bazaar, Shah discusses Kyzatrex, the challenges of hormone health, and the future of testosterone treatment.
-----------2
The American Bazaar: What inspired Marius Pharma to focus on testosterone therapy, and what gaps in treatment were you aiming to address with Kyzatrex?
Shalin Shah: Testosterone is one of the best barometers of overall health, yet it has been widely misunderstood. Hormone health should be treated as seriously as any other aspect of well-being. Testosterone therapy has been used successfully for nearly a century—including for women during menopause—but its progress was hindered in the 1990s when it was classified as a Schedule III controlled substance. Despite opposition from the FDA, the AMA, and the DEA, this decision was driven by political pressure rather than science. At Marius Pharma, we aim to challenge outdated perceptions, increase awareness, and provide effective, accessible treatment options for those who need them.
----------------
How prevalent is hypogonadism, which is characterized by low testosterone levels, in the United States? Why does it need urgent attention?
An estimated 20 million men between ages 25 and 75 in the U.S. suffer from low testosterone. Despite its high prevalence, hypogonadism often goes undiagnosed and untreated, leading to downstream health consequences such as metabolic disorders, cardiovascular disease, and reduced quality of life. Addressing this condition is crucial for improving overall health outcomes and preventing chronic disease.
-----------
Do you think it is not taken seriously enough by Americans?
No, but that’s largely due to a lack of education on the issue. If people aren’t aware of the health risks associated with low testosterone, how can they take it seriously? Raising awareness and normalizing discussions around hormone health are essential steps in ensuring that men receive the care they need.
-------------
While most doctors prescribe routine cholesterol and sugar level tests for their patients, not many recommend testosterone tests, unless there is a specific condition that warrants the tests. Do you think that should change?
Absolutely. That’s one of the reasons we launched The Testosterone Project (testosteroneproject.com), which advocates for routine testosterone testing. Early detection of hormonal imbalances can significantly improve quality of life, help prevent chronic diseases and reduce long-term healthcare costs.
-------------
Kyzatrex was launched in the United States in October 2022. How successful has it been in the market? Do you have plans to launch it in other parts of the world?
Kyzatrex received FDA approval in July 2022 and has since gained traction, particularly through partnerships with major telehealth retailers like Whole HealthRx by The Vitamin Shoppe, HenryMeds, and Thrive. We also plan to expand internationally and have filed submissions with multiple international agencies.
---------------
Testosterone treatment, it is believed, would help diabetic and cardiovascular patients. Can you elaborate?
Testosterone plays a vital role in both metabolic and cardiovascular health. It acts as an insulin sensitizer, helping to improve glucose metabolism and potentially benefiting men with Type 2 diabetes. Research has shown that testosterone therapy can slow or even reverse atherosclerosis, lower cholesterol levels, and reduce the risk of heart disease in aging men. Studies also indicate that age-related declines in testosterone are associated with an increased risk of cardiovascular disease, while maintaining healthy testosterone levels is linked to better heart function and overall health. Low testosterone in men with congestive heart failure has been associated with poorer outcomes, further underscoring the importance of proper hormone management.
=============
There has been some controversy around testosterone therapy and its potential risks. How does Kyzatrex address safety concerns, and what does the latest research say?
Testosterone therapy carries a Black Box Warning, but the 2023 Traverse Study found that TRT (Testosterone Replacement Therapy) does not increase major cardiovascular risks, such as heart attacks, strokes, or hospitalization for heart failure.
-----------
How does the bioavailability of Kyzatrex compare to injectable or transdermal testosterone treatments?
The important aspect to evaluate in Testosterone treatment is how closely are you mimicking the natural circadian rhythm of the body. Injectables often taken weekly or more, have a hard time accomplishing that. Kyzatrex daily is able to more closely replicate this and thus, we see it evolving into the standard of care.
-------------
What regulatory challenges did you face in bringing Kyzatrex to market, and how did Marius Pharma navigate them?
While not uncommon, the FDA threw a curveball at Marius without real basis and understanding of the issue despite Kyzatrex generating the most compelling efficacy and safety data in the testosterone space. The FDA’s stance jeopardized years of work and over $100 million in investment. Unlike many companies that avoid pushing back against the FDA, we took an unprecedented approach by engaging at all levels of the FDA and openly addressing what we saw as bias against hormone therapy and smaller pharmaceutical companies. This strategy ultimately led to Kyzatrex’s rightful approval, ensuring that patients have access to this much-needed treatment.
-----------
How do you envision the future of testosterone therapy evolving, and what role will Marius Pharma play in shaping it?
The future of testosterone therapy lies in breaking down outdated stigmas and expanding access to treatment. Through The Testosterone Project, we are advocating for routine testosterone testing to improve early diagnosis, expanding awareness of testosterone therapy’s role in women’s health, and pushing for the de-scheduling of testosterone from its current classification as a Schedule III controlled substance. Marius Pharma is committed to driving these changes, ensuring that testosterone therapy is recognized as an essential component of healthcare rather than a controversial topic.
=--------------
What steps are you taking to educate both physicians and patients about the benefits and proper use of Kyzatrex?
We are committed to raising awareness through multiple channels, including educational marketing materials, webinars, and provider training sessions. We also operate ReThink Testosterone, a disease state awareness platform that serves as a resource for both healthcare professionals and patients, helping to debunk myths and provide accurate, science-backed information about testosterone deficiency and treatment options.
---------------
Marius Pharma is competing with some established players in the testosterone therapy market. What differentiates your approach and business strategy?
Unlike competitors that rely on insurance-based models, Kyzatrex is a cash-pay option, eliminating prior authorization headaches and making treatment more accessible and often actually more affordable. This allows patients to start therapy without delays and reduces administrative burdens for healthcare providers.
----------
Are there any upcoming research studies or clinical trials that could further validate or expand the applications of Kyzatrex?
Given the tremendous adoption of GLP1s and the muscle mass loss that occurs, we are starting a study with Kyzatrex and Semaglutide. This could have tremendous positive ramifications for a large portion of the U.S. population. We are also currently conducting a study with Dr. Mohit Khera to evaluate the effects of Kyzatrex on male fertility, specifically its impact on LH and FSH levels. This research could provide critical insights into how oral testosterone therapy fits within broader fertility considerations for men.
