Is PT-141 / Bremelanotide FDA approved?
Current U.S. status for PT-141 / Bremelanotide: Bremelanotide is FDA approved as Vyleesi only for premenopausal women with acquired, generalized hypoactive sexual desire disorder; it is not indicated for men, postmenopausal women, or sexual performance enhancement.
DIRECT ANSWER
PT-141 / Bremelanotide FDA status.
Current U.S. status for PT-141 / Bremelanotide: Bremelanotide is FDA approved as Vyleesi only for premenopausal women with acquired, generalized hypoactive sexual desire disorder; it is not indicated for men, postmenopausal women, or sexual performance enhancement.
Reviewed August 8, 2026. Each statement links to its evidence record, followed by the primary and official sources used for this answer.
Bremelanotide is FDA approved as Vyleesi only for premenopausal women with acquired, generalized hypoactive sexual desire disorder; it is not indicated for men, postmenopausal women, or sexual performance enhancement.
Open evidence recordPT-141 is commonly marketed more broadly than the evidence allows. The decision-grade record concerns FDA-reviewed bremelanotide, its subcutaneous formulation, and one narrow population and indication.
Open evidence recordApproval, evidence maturity, commercial access, and sport status answer different questions. The full record keeps them separate.
Open evidence recordPRIMARY & OFFICIAL SOURCES
Sources for this answer.
3 source records, with duplicates removed.