Experts react to FDA’s potential pathway for TRT label expansion

Following the FDA’s announcement on a potential pathway to expand testosterone replacement therapy (TRT) labeling,¹ leading experts in men’s health shared their perspectives on what this development could mean for patients and clinical practice. In the following video, Helen L. Bernie, DO; Jesse N. Mills, MD; Landon Trost, MD; and Mohit Khera, MD, MBA, MPH, discuss the significance of the FDA’s announcement and how broader treatment access could affect patient care if label changes are approved.

In their announcement, the FDA specifically encouraged sponsors of currently approved TRT products to engage in discussions regarding supplemental new drug applications for low libido in men with idiopathic hypogonadism—a population that has historically fallen outside existing labeled indications. While any potential expansion would still require strong evidence supporting safety and efficacy, the move signals growing regulatory interest in addressing an unmet need that can significantly impact quality of life.

Related: Landon Trost, MD, reacts to FDA’s “positive move”

As the experts explain, this move could have potential implications for patient counseling, insurance coverage, and overall access to TRT. The agency requested that sponsors contact them by April 30, 2026 regarding potential new indications.

REFERENCE

1. FDA Takes Step Forward on Testosterone Therapy for Men. News release. US Food & Drug Administration. April 16, 2026. Accessed April 16, 2026. https://www.fda.gov/news-events/press-announcements/fda-takes-step-forward-testosterone-therapy-men