Home | Regulatory Tracker | PT-141 (bremelanotide)
PT-141 (bremelanotide)
FDA-approved (NDA)
as of October 2026
By Stephen Kimball, 26+ years researching the health, wellness, supplement, and peptide industries
As of October 2026, bremelanotide is FDA-approved as Vyleesi for one use: premenopausal women with acquired, generalized hypoactive sexual desire disorder (persistent low desire that causes distress and isn’t explained by another condition). It isn’t approved for men or postmenopausal women. Because it’s part of an approved drug, a pharmacy can compound it with a prescription, within FDA’s limits on copying approved products, but a compounded version isn’t FDA-approved. Vials sold as “PT-141” on research sites come with no prescription and no guarantee of what’s inside.
Sources
Vyleesi — Drugs@FDA application record
U.S. Food & Drug Administration
dated Jun 2019
FDA approves new treatment for hypoactive sexual desire disorder in premenopausal women
U.S. Food & Drug Administration
dated Jun 2019
Change log
June 2019
FDA approves Vyleesi for acquired, generalized HSDD in premenopausal women.
May 2009
FDA publishes withdrawal of Geref Diagnostic approval (NDA 19-863) at the maker’s request after discontinuation.
March 2013
FDA determines Geref was not withdrawn for safety or effectiveness reasons.