WASHINGTON, D.C. — Federal regulators are exploring whether testosterone replacement therapy could be expanded to treat low libido in certain men, a move that could broaden access to treatment for a condition affecting quality of life.
What This Means for You
- Testosterone therapy may be expanded to treat low libido in some men
- Any new approval would require strong evidence of safety and effectiveness
- Drugmakers must submit data to the FDA to pursue expanded use
The U.S. Food and Drug Administration said it is encouraging manufacturers of approved testosterone replacement therapy products to engage with the agency if they are interested in seeking approval for a new use.
Testosterone replacement therapy, commonly referred to as TRT, is currently approved only for men with hypogonadism caused by known structural or genetic conditions. Hypogonadism is a condition where the body produces low levels of testosterone.
Potential New Use Under Review
The FDA said emerging clinical data suggest TRT may also benefit men experiencing low libido linked to idiopathic hypogonadism, a form of the condition where no specific cause is identified.
“New and emerging data suggest there may be an opportunity to help men suffering from symptoms that significantly affect quality of life,” FDA Commissioner Marty Makary said.
The agency’s preliminary review included published clinical studies and discussions from a December 2025 expert panel.
Approval Process and Requirements
Any expansion of TRT’s approved uses would require drugmakers to submit a supplemental new drug application, which is a request to modify an existing drug approval to include a new indication.
The FDA said companies must provide substantial evidence showing the treatment is both safe and effective for the new population.
“Sexual health is an important component of overall well-being and quality of life,” said Brian J. Christine, assistant secretary for health.
Next Steps
Manufacturers interested in pursuing the expanded indication are encouraged to contact the FDA by April 30 to discuss data requirements and the application process.
Officials emphasized that no changes to current approvals have been made and that any new use would undergo full regulatory review before being authorized.
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