The US Food and Drug Administration announced that it is encouraging sponsors of approved testosterone replacement therapy products to consider pursuing a potential new indication for low libido in men with idiopathic hypogonadism, an initial step to advance treatment options.

Currently, testosterone replacement therapy (TRT) products are approved only for men with hypogonadism attributable to established structural or genetic causes. Following a preliminary review of published clinical literature and discussion at a December 2025 expert panel meeting, the US Food and Drug Administration (FDA) identified data suggesting that TRT may be safe and effective for some men with decreased libido associated with idiopathic hypogonadism, defined by low testosterone levels without an identifiable etiology.

The agency’s review focused on findings from well-controlled clinical trials assessing relevant clinical outcomes. Based on this assessment, the FDA is encouraging holders of approved TRT new drug applications to contact the agency regarding submission of a supplemental application if they intend to seek approval for this potential indication. Sponsors were advised to initiate contact by April 30 to obtain further information regarding submission requirements.

“New and emerging data suggest there may be an opportunity to help men suffering from symptoms that significantly affect quality of life[…] We are eager to work with sponsors to further evaluate this potential new use while upholding our rigorous standards for safety and effectiveness,” said FDA Commissioner Marty Makary, MD, MPH. Assistant Secretary for Health Brian J. Christine, MD, added, “Sexual health is an important component of overall well-being and quality of life.”

The FDA highlighted that any approval for a new indication would require substantial evidence demonstrating effectiveness and that the benefits outweigh the risks for the intended patient population.

Source: FDA