FDA asks testosterone therapy firms to seek expanded indication

The US Food and Drug Administration (FDA) is asking makers of testosterone replacement therapy (TRT) products to consider submitting applications to expand the use of their products for low libido in men with idiopathic hypogonadism. The move comes after a panel of experts called for relaxing regulatory restrictions on the products to address conditions such as heart disease and diabetes.

On 16 April, FDA said it had reached out to TRT manufacturers with the request, arguing that the products may be able to improve the health and quality of life for men with low testosterone.

“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. “We are eager to work with sponsors to further evaluate this potential new use while upholding our rigorous standards for safety and effectiveness.”

TRT products are currently only approved for men with a specific form of hypogonadism. However, in December 2025, a panel of experts discussed the implications of expanding the indication for the products and said that the data suggest it may be safe and effective for certain men with low libido related to idiopathic hypogonadism characterized as low testosterone without an identifiable cause. The panel was not an advisory committee that the FDA typically convenes in such circumstances, and unlike traditional advisory committees, it does not require the same level of scrutiny when selecting members. (RELATED: FDA panel calls for easing restrictions on testosterone replacement therapy for men, Regulatory Focus 12 December 2026)

During the December meeting, Makary said that despite the potential benefits of TRT, men with low testosterone levels often do not receive the treatment because the treatment is classified as a controlled substance because of its illegal use in sports. The expert panel also attributed its limited usage to common misconceptions that it can lead to prostate cancer, stroke, and heart disease.

On the contrary, some of the experts argued that testosterone is a biomarker and expanding the use of TRT could help treat depression, heart disease, and diabetes in men.

“Sexual health is an important component of overall well-being and quality of life,” said Brian Christine, 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,” he added.

FDA said that manufacturers with TRT new drug applications (NDA) interested in expanding their indications should contact the agency for further information, including the data the agency wants to see for approval by 30 April. The agency emphasized that approval for a new indication needs to demonstrate substantial evidence of effectiveness and that the benefits outweigh the risks for the intended population.