Upcoming FDA Expert Panel on Testosterone Replacement Therapy for Men

@Nelson Vergel

We need you here!

FDA Expert Panel on Testosterone Replacement Therapy for Men

FDA Expert Panel on Testosterone Replacement Therapy for Men

www.fda.gov

Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31, Great Room, Silver Spring, MD 20993-0002. There will be limited seating for the public.

Registration: Registration is only required for in-person listen-in attendance. Space is limited. Please plan to arrive at least 30 minutes prior to the start time to be checked in.

How to Virtually Attend: This FDA Expert Panel will be live streamed over the FDA’s YouTube channelExternal Link Disclaimer.

FDA plans to provide a free of charge live webcast of the Expert Panel. If there are instances where the webcast transmission is not successful, staff will work to re-establish the transmission as soon as possible.

 

Shalin Shah

Fast Track Testosterone: Umbrella and Comorbidity Approvals

Built for Access: Closing the Diagnosis & Treatment Gap

Testosterone Therapy: Untapped Billion-Dollar Savings Lever

Thread 'The Testosterone Project'

Nov 23, 2024

About - The Testosterone Project

At the Testosterone Project, we believe that testosterone is essential for a healthy, balanced life for men and women. Learn more about how we advocate for you.

testosteroneproject.com

The Testosterone Project Launches on National Testosterone Awareness Day, November 17

New Nonprofit Founded by Leading Testosterone Experts Seeks to Provide Equal Access to Care for Both Men and Women...

www.globenewswire.com

RALEIGH, N.C., Nov. 15, 2024 (GLOBE NEWSWIRE) -- The Testosterone Project, a new nonprofit founded by leading experts in the fields of testosterone treatment and general metabolic health, launches in conjunction with National Testosterone Awareness Day on November 17. The national nonprofit organization will focus on addressing the stigma and...

• madman
• hypogonadism; testosterone; tth; men's health
• Replies: 16
• Forum: Testosterone and Men's Health Articles

Thread 'Marius Pharmaceuticals Unveils New Corporate Website'

Feb 22, 2025

Marius Pharma is paving the way here for oral T-Therapy!

Marius Pharmaceuticals Unveils New Corporate Website and Announces Longevity & Endocrinology Advisory Boards

RALEIGH, N.C., Feb. 21, 2025 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals, a biopharmaceutical company dedicated to redefining the treatment of...

www.globenewswire.com

RALEIGH, N.C., Feb. 21, 2025 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals, a biopharmaceutical company dedicated to redefining the treatment of testosterone deficiency, is excited to announce the launch of its new corporate website, designed to provide comprehensive education on the importance of testosterone in overall health. In...

• madman
• hypogonadism; oral t ;kyzatrex; men's health
• Replies: 8
• Forum: Testosterone and Men's Health Articles

Thread 'Dr. Khera- Why I'm Excited About The Testosterone Project'

Mar 15, 2025

The Testosterone Project on Instagram: "Exciting news! Dr. Mohit Khera (@drmohitkhera) is joining The Testosterone Project board. Together, we’re on a mission to redefine hormonal health and educate the public on the vital role testosterone plays in

1,189 likes, 37 comments - the_testosterone_project on November 7, 2024: "Exciting news! Dr. Mohit Khera (@drmohitkhera) is joining The Testosterone Project board. Together, we’re on a mission to redefine hormonal health and educate the public on the vital role testosterone plays in both men’s...

www.instagram.com

Exciting news! Dr. Mohit Khera (@drmohitkhera) is joining The Testosterone Project board. Together, we’re on a mission to redefine hormonal health and educate the public on the vital role testosterone plays in both men’s and women’s wellness. From energy and mood to cognitive function and beyond, testosterone is a key factor in quality of life.

At The Testosterone Project, we’re focused on raising awareness, advocating for better access, and advancing research. Let’s bring hormone health to...

• madman
• testosterone project; t-therapy; health
• Replies: 3
• Forum: Testosterone and Men's Health Articles

• 

Thread 'Marius Pharmaceuticals Helps Drive FDA’s Landmark Testosterone Label Update, Removing Black Box Warning'

Mar 4, 2025

Marius Pharmaceuticals Helps Drive FDA’s Landmark Testosterone Label Update, Removing Black Box Warning

RALEIGH, N.C., March 03, 2025 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals, is pleased to announce that the U.S. Food and Drug Administration (FDA) has...

www.globenewswire.com

RALEIGH, N.C., March 03, 2025 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals, is pleased to announce that the U.S. Food and Drug Administration (FDA) has implemented significant labeling changes for KYZATREX® (testosterone undecanoate) CIII capsules. This decision follows the conclusion of the TRAVERSE trial and comprehensive blood pressure monitoring studies, marking a pivotal advancement in...​

• madman
• hypogonadism; t-therapy; fda; cvd
• Replies: 5
• Forum: Testosterone and Men's Health Articles

 

Thread 'Reevaluating the threshold for low total testosterone'

May 12, 2025

Reevaluating the threshold for low total testosterone

In this podcast, Adith Arun from the Yale New Haven Hospital Center for Outcomes Research and Evaluation, and a third year medical student at the Yale School of Medicine, discusses a letter to the editor, “Reevaluating the threshold for low total testosterone,” published in the May 2025 issue of...

myadlm.org

Bob Barrett:

Well, finally, looking ahead, what kind of research do you think is needed to ensure that guidelines and clinical practices align with the latest evidence on testosterone measurement?




Adith Arun:

Yeah, that’s a great question, Bob. And I think there are a few different cutoffs out there by different bodies, which you highlighted earlier in our conversation. And I think the first step is to try to...

• madman
• hypogonadism; t assays; standardized/harmonized
• Replies: 2
• Forum: Testosterone and Men's Health Articles

• 

 

Thread 'Dr. Shalender Bhasin: Optimizing the Diagnosis and Treatment of Hypogonadism 2025'

Oct 7, 2025

Nelson's house u heard it here first!

Dr. Shalender Bhasin!

* over the past 4 decades he has become a global leader in the biology of androgens, sarcopenia and aging related functional decline, his research has shaped clinical guidelines, its informed public health policy particularly around testosterone therapy, anabolic interventions and then the development of function promoting therapies




Pay attention to 25:40-34:36 of the presentation where he explains the importance of measuring free testosterone using a standardized Equilibrium Dialysis method!

Explains the...

• madman
• hypogonadism; diagnosis/treatment; trt
• Replies: 31
• Forum: Testosterone and Men's Health Articles

 

Thread 'Re-evaluating the role of Free Testosterone and SHBG'

Sep 2, 2025

We do it big here at Nelson's stomping ground!

Dr. Leen Antonio (UZ Leuven)!

She has collaborated with the heavyweights in the field Dr. Bhasin and Dr. Jasuja (Brigham and Women's Hospital)), Dr. Fiers and team (UZ Ghent) on research related to free testosterone.

• madman
• hypogonadism; free testosterone; shbg
• Replies: 25
• Forum: Blood Test Discussion

• 

Thread 'Importance of free testosterone measurement in assesssing androgen disorders'

Jun 15, 2025

As usual Nelson's house is where it's at!

Importance of free testosterone measurement in assessing androgen disorders

Thursday, March 27, 2025 at 1:00 PM Eastern Daylight Time.

event.on24.com

Testosterone imbalances affect men, women, and children differently. In males, testosterone deficiency (hypogonadism) can lead to low libido, fatigue, and muscle loss, while excess may contribute to aggression and cardiovascular risks. In females, testosterone excess (hyperandrogenism), often associated with polycystic ovary syndrome (PCOS) or adrenal disorders, can cause excess hair growth, weight gain, and menstrual irregularities. In children...

• madman
• hypogonadism; free t; accuracy assays/diagnosis
• Replies: 24
• Forum: Testosterone and Men's Health Articles

 

Thread 'Fix Testosterone’s Outdated Label?'

Jan 15, 2026

The FDA Listened on Estrogen. Is Testosterone Next?

Dr Rachel Rubin and experts Dr Mohit Khera and Dr Abraham Morgentaler discuss a landmark FDA meeting and why it’s time to modernize testosterone therapy labeling and scheduling.

www.medscape.com

Rachel Rubin, MD

Hello, everyone. I’m Dr Rachel Rubin, and we’re here for another episode of Sex Matters. I am thrilled to introduce two of my major mentors. I can’t say enough wonderful things about these two human beings. What I know about advocacy and education has really come from these two men, as well as a few other people.


They did something significant recently and are joining me to talk...

• madman
• hypogonadism; testosterone therapy; fda
• Replies: 2
• Forum: Testosterone and Men's Health Articles

 

Thread 'Testosterone’s Schedule III Status The Evolving U.S. Regulatory Landscape'

Feb 8, 2026

All those so called gurus polluting social media and the half-wits pushing that more T is better mentality bull*** stinkin up those so called men's health/HRT forums!


* At the same time, the non-medical environment has evolved, with online marketplaces, informal supply chains, and social-media– driven “optimization” narratives accelerating diffusion and complicating traditional diversion-control approaches7–9

* The evidence summarized in this review consistently differentiates supervised therapeutic use from non-medical use patterns. The...

• madman
• hypogonadism; testosterone; fda; mens health
• Replies: 8
• Forum: Testosterone and Men's Health Articles

 

Much more to the story here!


* Longer-term studies are still needed to determine whether testosterone therapy is safe with respect to cardiovascular, thromboembolic, and prostatic diseases. However, recent placebo-controlled trials (of 1-4 years) of TRT offer reassurance about the risk of cardiovascular and prostate disease (prostate cancer and lower urinary tract symptoms of benign prostatic hyperplasia, although less so for pulmonary emboli and thrombotic risk. Because the recent placebo-controlled trials of TRT excluded men at high risk of thromboembolic and prostatic disease, shorter studies (1-5 years) of typical mid- and high-normal range testosterone dosages used clinically must be performed in men with low serum testosterone and at high risk for these diseases. Placebo-controlled-studies with typical mid-range and high-range testosterone dosages for men with low serum testosterone with follow-up for up to 10, 15 and 20 years must be done to determine long-term risks of testosterone therapy for cardiovascular and prostatic disease.

Thread 'Endocrine Society Submits Comments to FDA Expert Panel on Testosterone Replacement Therapy for Men'

Feb 13, 2026

Much more to the story here!


* Longer-term studies are still needed to determine whether testosterone therapy is safe with respect to cardiovascular, thromboembolic, and prostatic diseases. However, recent placebo-controlled trials (of 1-4 years) of TRT offer reassurance about the risk of cardiovascular and prostate disease (prostate cancer and lower urinary tract symptoms of benign prostatic hyperplasia, although less so for pulmonary emboli and thrombotic risk. Because the recent placebo-controlled trials of TRT excluded men at high risk of thromboembolic and...

• madman
• hypogonadism; fda; endocrine society; health
• Replies: 4
• Forum: Testosterone and Men's Health Articles