The U.S. Food and Drug Administration today is taking an initial step to advance treatment options for men’s health by encouraging sponsors of approved testosterone replacement therapy (TRT) products to contact FDA for information if they are interested in pursuing a potential new indication for low libido in men with idiopathic hypogonadism (without a known cause).
“New and emerging data suggest there may be an opportunity to help men suffering from symptoms that significantly affect quality of life,” said FDA Commissioner Marty Makary, M.D., M.P.H. “We are eager to work with sponsors to further evaluate this potential new use while upholding our rigorous standards for safety and effectiveness.”
Currently, FDA-approved TRT products are indicated only for men with specific forms of hypogonadism tied to known structural or genetic causes. Following a preliminary review of emerging evidence from published clinical literature and discussion at a December 2025 expert panel meeting, the agency identified data suggesting that TRT may be safe and effective for certain men experiencing low libido related to idiopathic hypogonadism—a condition characterized by low testosterone levels without an identifiable cause.
“Sexual health is an important component of overall well-being and quality of life,” said Brian J. Christine, M.D., Assistant Secretary for Health. “This is an exciting opportunity to build on new science and potentially expand treatment options for men with hypogonadism. We encourage continued innovation and collaboration to bring forward high-quality evidence that can expand options for men with hypogonadism.”
The agency’s preliminary assessment focused on published literature of rigorous, well-controlled clinical trials evaluating relevant outcomes. Following this review, the agency is encouraging holders of approved TRT new drug applications (NDAs) that are interested in seeking approval for the treatment of low libido in men with decreased libido associated with idiopathic hypogonadism to contact FDA for further information regarding submission of a supplemental NDA, including data needed to support an approval. Application holders are encouraged to contact the FDA by April 30.
FDA emphasizes that any approval for a new indication would require demonstration of substantial evidence of effectiveness and that the benefits outweigh the risks for the intended population.
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