U.S. Food and Drug Administration (FDA)
Is Bremelanotide (PT-141) legal in United States?
Approved, restrictedFDA-approved as Vyleesi (2019) only for low sexual desire in premenopausal women with a specific diagnosis
Approved, but with limits on who can get it or how.
Bremelanotide (also called PT-141) is FDA-approved as Vyleesi, first approved 21 June 2019, for premenopausal women with acquired, generalized hypoactive sexual desire disorder that is not explained by another medical or psychiatric condition, relationship problems or a medicine. The label says it is not indicated for postmenopausal women. Bremelanotide products sold as 'PT-141' with research-use-only labels have no approval and FDA cited such a seller in an August 2026 warning letter.
Last verified 2026-09-29 · how we verify
Bremelanotide (PT-141) elsewhere
Sources (2)
- 01VYLEESI (bremelanotide) injection prescribing informationU.S. Food and Drug Administration · 2020-10 · accessed 2026-09-29
- 02FDA warning letter 735127 to an online seller of retatrutide, semaglutide, SS-31, PT-141 and tesamorelin labelled 'research use only'U.S. Food and Drug Administration · 2026-08-24 · accessed 2026-09-29