Key Takeaways From Expert FDA TRT Panel. Click here to watch →

A Historic Conversation on Testosterone Replacement Therapy

On December 10, 2025, the FDA convened leading physicians, researchers, and health officials to examine the latest scientific evidence on testosterone replacement therapy for men. The panel addressed safety data, treatment barriers, and the growing need to prioritize men’s health.

Key Takeaways from the FDA Expert Panel

The quotes below are taken from a live transcript and displayed for illustrative purposes.

  1. Testosterone Therapy Does NOT Increase Cardiovascular Risk

    “Low testosterone increases cardiovascular risk. Testosterone therapy does not.” — Dr. Martin Miner, Clinical Professor, Brown University

  2. Testosterone Therapy Does NOT Increase Prostate Cancer Risk

    “In 2025, the belief that testosterone is dangerous for the prostate is no more scientifically valid than belief in the tooth fairy.” — Dr. Abraham Morgentaler, Harvard University

  3. Testosterone Is NOT a Lifestyle Drug — It’s Preventive Medicine

    “Testosterone therapy is not a lifestyle drug. It is a cornerstone of preventive health, a therapy that restores health, function, and longevity.” — Dr. Helen Bernie, Indiana University

  4. The TRAVERSE Trial Confirmed Long-Term Safety

    “The TRAVERSE trial, with over 5,200 men, demonstrated that testosterone did not increase the risk of heart attack, stroke, or prostate cancer.” — Dr. Mohit Khera, Baylor College of Medicine

  5. Testosterone Schedule III Classification Creates Unnecessary Barriers

    “Testosterone has lower abuse potential than caffeine, yet is regulated more tightly than cannabis in half of this country.” — Shalin Shah, CEO, Marius Pharmaceuticals

  6. Low Testosterone Is Strongly Linked to Bone Fractures

    “66% of elderly men with hip fractures have low testosterone. Hip fractures in elderly males result in 31% mortality within one year.” — Dr. Richard Iorio, FDA Principal Medical Advisor

  7. Men’s Health Crisis Demands National Action

    “Men’s life expectancy is 6.5 to 7 years shorter than women’s. 80% of suicides are men. We have a men’s health crisis in this country. The time is now for a federal men’s health initiative.” — ADM Brian Christine, HHS Assistant Secretary for Health

  8. Testosterone Therapy Could Save Billions in Healthcare Costs

    “In the VA, normalization of testosterone in over 80,000 hypogonadal men was associated with a 56% lower all-cause mortality, and meaningful reductions in heart attacks and strokes. If you apply these reductions to 1 million high-risk men, you’re talking on the order of $5 billion in MI and stroke costs alone can be saved.” — Shalin Shah, CEO, Marius Pharmaceuticals

`What the Panel Experts Are Saying

“There are more than two dozen studies — including men with metastatic disease, and several published by participants at this panel here today, and myself. Not one has shown ​​increased rates of recurrence or progression (of Prostate Cancer).”

— Dr. Abraham Morgentaler, Harvard University

“If we care about the future health of American men, we cannot let clinical care be dictated by insurance companies.”

— Shalin Shah, CEO, Marius Pharmaceuticals

“Men are dying younger. Men are dying sooner. We have a men’s health crisis in this country. We need a national strategy, and today I’m calling for that.”

— ADM Brian Christine, HHS Assistant Secretary for Health

“Testosterone is one of the best markers of a man’s overall health.”

— Dr. Mohit Khera, Baylor College of Medicine

For Healthcare Providers

KYZATREX (testosterone undecanoate) capsules, CIII, is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Safety and efficacy of KYZATREX in males less than 18 years old have not been established. Safety and efficacy of KYZATREX in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.

View Prescribing Information

View Frequently Asked Questions

Please see below for Important Safety Information 

What is KYZATREX®
KYZATREX® (testosterone undecanoate) is a prescription drug that is used to treat adult men who have low or no testosterone levels due to certain medical conditions.

KYZATREX® is a controlled substance (CIII) because it contains testosterone. 

It is not known if KYZATREX® is safe or effective in males younger than 18 years old. Improper use may affect bone growth in children.

It is not known if KYZATREX® is safe or effective in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”).

KYZATREX® is not meant for use by women.

Important Safety Information for KYZATREX®
Do not take KYZATREX® if you: have breast cancer; have or might have prostate cancer; are a woman who is pregnant (KYZATREX may harm your unborn baby); or are allergic to KYZATREX® or any of its ingredients.

Before you take KYZATREX®, tell your healthcare provider about all of your medical conditions, including if you: have high blood pressure or are treated for high blood pressure; have a history of diabetes; have heart problems; have high red blood cell count (hematocrit) or high hemoglobin laboratory value; have urinary problems due to an enlarged prostate; have liver or kidney problems; or have problems breathing while you sleep (sleep apnea).

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking KYZATREX® with certain other medicines can affect each other. Especially, tell your healthcare provider if you take: insulin; medicines that decrease blood clotting (blood thinners); corticosteroids; or medicines that increase blood pressure, such as some cold medicine and pain medicines.
KYZATREX may cause other serious side effects including:
  • Increase in red blood cell count (hematocrit) or hemoglobin, which can increase the risk of blood clots, strokes, and heart attacks. You may need to stop KYZATREX® if your red blood cell count increases.
  • If you already have an enlarged prostate, your signs and symptoms may worsen while taking KYZATREX®. These may include: increased urination at night; trouble starting your urine stream; urinating many times during the day; urge to go to the bathroom right away; a urine accident; inability to pass urine or weak urine flow.
  • Increased risk of prostate cancer.
  • Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.
  • Abuse. Testosterone can be abused when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. Abuse can cause serious heart and psychological side effects.
  • In large doses, KYZATREX® may lower your sperm count.
  • Liver problems. Symptoms of liver problems may include: nausea or vomiting; yellowing of your skin or whites of your eyes; dark urine; pain on the right side of your stomach area (abdominal pain).
  • Swelling of your ankles, feet, or body (edema), with or without heart failure.
  • Enlarged or painful breasts.
  • Breathing problems while you sleep (sleep apnea).
Call your healthcare provider right away if you have any of the serious side effects listed above.
The most common side effect of KYZATREX is high blood pressure. Other side effects may include: headache, joint or back pain, diarrhea, increased red blood cell count, anxiety, constipation, swelling of the legs, and increased prostate specific antigen (PSA) levels.

These are not all the possible side effects of KYZATREX®. For more information, ask your healthcare provider or pharmacist. 
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Marius by visiting www.mariuspharma.com.
Keep KYZATREX and all medicines out of the reach of children.
See Full Prescribing Information and Medication Guide for KYZATREX.