FDA Encourages Sponsors to Pursue New Testosterone Therapy Indication for Low Libido

Fri, 17 Apr 2026 03:14:55 +0000
Pharmaceuticals

The FDA announced it is taking an initial step to expand treatment options for men with low libido by encouraging sponsors of approved testosterone replacement therapy (TRT) products to express interest in pursuing a potential new indication for idiopathic hypogonadism. Following a preliminary review of published clinical literature and a December 2025 expert panel discussion, FDA identified data suggesting TRT may be safe and effective for certain men with low libido related to low testosterone without an identifiable cause.