US Health Dept. Seeks Testosterone Therapy Label Revisions

The U.S. Department of Health and Human Services has requested significant updates to the prescribing labels for testosterone replacement therapies, a move that could expand access to the treatment for men with age-related low testosterone. The agency announced the request on June 18, 2026, following a review of new clinical data.

The proposed changes would remove a key limitation added to labels in 2015, which stated that the safety and effectiveness of testosterone therapy had not been established for men with age-related hypogonadism. Health and Human Services Secretary Robert F. Kennedy Jr. said updating the labels to reflect current evidence supports informed medical decisions and improves care. The request also calls for revising warnings related to prostate cancer risk and symptoms of an enlarged prostate.

Officials said the decision is based on newer scientific evidence, including the large TRAVERSE clinical trial involving more than 5,200 men. That study found no meaningful increase in the risk of major cardiovascular events, such as heart attack or stroke, among men receiving testosterone therapy. Cardiovascular risk had been a primary reason for the 2015 label restriction.