The Thyroid Fixer – Episode 569

Testosterone Breakthrough: A New Testosterone Solution Rocking the HRT World with Shalin Shah
Date: October 14, 2025
Host: Dr. Amie Hornaman
Guest: Shalin Shah, CEO of Marius Pharmaceuticals

Episode Overview

This episode explores the vital role of testosterone in both men and women, busts longstanding myths about hormone therapy, and spotlights a groundbreaking new oral testosterone option, Kyzatrex. Host Dr. Amie Hornaman and guest Shalin Shah (CEO of Marius Pharmaceuticals, makers of Kyzatrex) tackle why testosterone matters, the history and current state of testosterone replacement, common barriers to care, and how their new oral formulation overcomes previous safety and efficacy issues. Listeners get practical clinical insights and tools—whether you're a patient with low T or a clinician wanting to optimize hormone health for your patients.

Key Topics & Discussion Points

The Importance of Testosterone for All Genders

• Broad Impact: Testosterone is not just a "male hormone"—it's crucial for metabolic health, brain function, bone strength, motivation, mood, and even cancer and cardiovascular protection for both sexes. (09:07–15:54)
• Mental Health: "92.7% reported depressive symptoms [with low T]...Post therapy...2%. Massive delta." – Shalin Shah (13:14)
• Longevity: Low testosterone is directly linked to all-cause mortality and diseases like Type 2 diabetes, cardiovascular disease, dementia, and cancer.

The History and Misconceptions of TRT (Testosterone Replacement Therapy)

• Timeline: TRT began to gain traction in the 1980s but faced stigma after Olympic scandals led Congress to schedule testosterone as a controlled substance—the only hormone classified this way. (10:00)
• Setbacks and Stigma: Poor research in the 2010s fueled myths about cardiovascular and prostate cancer risks, setting back clinical practice.

Breaking Myths: Safety and Cancer/Cardiovascular Concerns

• Myth Busting: The TRAVERSE study (5000-patient, double-blind, placebo-controlled) found no cardiovascular or prostate cancer risk with TRT. Yet 84% of surveyed primary care providers hadn’t heard of these new results. (18:04)
• Cancer: Shalin shares a story of a patient with advanced cancer who improved dramatically with testosterone therapy:
  “She gives him testosterone, ends his life by a few years.” – Dr. Amie (16:21)

Barriers to Obtaining TRT

• Regulation: As a Schedule III drug, testosterone requires a DEA license, akin to opioids, and is challenging to obtain and prescribe. (20:37)
• Insurance Woes: Mass market therapies like testosterone are harder to get reimbursed than high-priced specialty drugs, despite their potential to lower long-term healthcare costs. (22:11)
• Speculation: “...if you make it easy [to access TRT], big pharma would lose sales of antidepressants and statins....” – Dr. Amie (20:48)

The Fight for Improved Access

• Advocacy: Marius Pharmaceuticals is working through a non-profit, The Testosterone Project, to get testosterone descheduled—a move that could reduce stigma and improve access for millions. (23:48)

Introducing Kyzatrex: A Game-Changing Oral Testosterone

Historical Concerns Over Oral Testosterone

• Liver Safety: Traditional oral testosterone was avoided due to liver toxicity—Kyzatrex uses lymphatic absorption, bypassing the liver altogether. “No liver toxicity through any of our trials or data. …That’s a huge breakthrough.” – Shalin (27:46–29:10)

Advantages Over Other Testosterone Delivery Methods (26:08–32:52)

• Daily, Physiological Dosing: Mimics the body’s natural circadian rhythm, improving effectiveness and reducing side effects.
• Reduced Side Effects:
  • Hematocrit: Less than 2% of Kyzatrex users had elevated hematocrit, versus over 80% seen in practice with injectables. (30:28)
  • Estrogen Conversion: Kyzatrex does not significantly aromatize to estrogen, so most users don’t need aromatase inhibitors. (31:39)
  • Testicular Atrophy & Fertility: Unlike traditional TRT, Kyzatrex doesn’t suppress LH & FSH to zero, potentially preserving fertility (current studies are ongoing). (34:17)
• Convenience: Oral, taken twice daily with food, making it an appealing alternative for needle-averse patients.

Addressing SHBG and Maximizing Free Testosterone (40:10–41:33)

• SHBG Reduction: Kyzatrex lowers sex hormone binding globulin, doubling or quadrupling free testosterone—optimal for those with high SHBG and low free T, especially women.
  • “You just really need to free up the free testosterone and work on that ratio. And if you can do that, bingo.” – Shalin (41:33)

Special Focus: Testosterone Therapy for Women (42:12–45:57)

• Overlooked Need: Women often have their testosterone needs ignored in favor of estrogen/progesterone. Symptoms of low T in women—muscle loss, low libido, brain fog, lack of motivation—typically go untreated unless extreme.
  • “It’s as simple as female testosterone deficiency … it needs to be female hypogonadism.” – Shalin (43:59)
• Current Approval Gap: In the U.S., women only qualify for TRT if diagnosed with hypoactive sexual desire disorder or osteoporosis.
• Pellets vs. Oral: Pellets can cause dangerous spikes in T (elevations up to 900+), cause irreversible androgenic side effects, and cannot be removed if there are issues. Oral Kyzatrex offers titratable, safer dosing.

Prescribing and Access to Kyzatrex (48:03–51:13)

• How to Prescribe: Through selected compounding and mail-order pharmacies, not at chain stores (CVS/Walgreens), keeping costs low and access high. Prescriptions are cash pay but often below compounding pharmacy prices—no insurance required.
• Dosing Equivalence: Oral doses are higher due to lower bioavailability (a few percent), but blood levels remain in physiological range; cannot be directly compared mg-to-mg with injectables. (47:06)

Notable Quotes & Moments

• On the safety of oral testosterone:
  "We see no liver toxicity through any of our trials or data. And I think that's a huge breakthrough." – Shalin Shah (27:46)

• On the gender-neutral benefits of T:
  "There's no reason to segment male versus female in the sense that testosterone, it works across the body in similar ways." – Shalin Shah (13:14)

• On SHBG and free T:
  “A lot of people have these normal T levels, high SHBGs and low free T levels. … You really need to free up the free testosterone.” – Shalin Shah (41:33)

• On pellets:
  "Pellets, Jack, a female's testosterone … you get this bolus dose and that's where you get the hair loss … you can't take the pellet out. … With an oral like Kyzatrex, you can adjust the dose." – Dr. Amie (45:01)

• On compliance and motivation:
  "When you see the benefits, the patient motivation to be compliant goes way up." – Shalin Shah (36:39)

Timestamps for Major Segments

• 09:07: Why testosterone matters for men & women
• 10:00: Brief history and current state of TRT
• 13:14: Mental health and other benefits of T therapy
• 18:04: Cardiovascular and prostate/cancer risk myths dispelled (TRAVERSE study)
• 20:37: Regulatory barriers and insurance frustrations
• 23:48: Activism: Fighting for testosterone descheduling
• 27:46: The Kyzatrex difference – oral T with no liver toxicity
• 31:39: Reduced estrogen conversion and side effects with Kyzatrex
• 34:17: Impact on fertility and testicular function
• 40:10: Role of SHBG and free testosterone optimization
• 42:12–45:57: TRT for women and the challenges of current options
• 48:03: How to prescribe and access Kyzatrex

Action Steps & Resources

• For Patients/Providers:

  • Learn more at kyzatrex.com for evidence, prescribing info, and resources.

• Advocacy:

  • Follow the progress of the testosterone descheduling initiative through The Testosterone Project.

• Clinical Integration:

  • Clinicians interested in research or adopting Kyzatrex into practice encouraged to connect with Marius Pharmaceuticals.

Closing Thoughts

Dr. Amie and Shalin Shah stress the importance of patient empowerment, education for providers, and advocating against the stigma and regulatory obstacles that block access to optimal hormone health. Kyzatrex appears to offer a long-awaited, practical, and physiologically sound oral testosterone therapy—potentially a lifeline for millions of men and women.

“It’s about access and stigma. How do we remove this for patients and providers? We want a healthier population.” – Shalin Shah (24:25)

For more details, visit kyzatrex.com and check out the show notes for provider and patient resources.