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Bremelanotide: FDA status and clinical evidence
Bremelanotide is approved by the FDA and is on the US market, first approved June 21, 2019, under 1 application. 10 studies are registered on ClinicalTrials.gov, reaching Phase 4. 4 unexpired patents are listed in the Orange Book.
FDA approval status
FDA review documents
Clinical evidence
By phase
Patents and generic availability
Molecular identity
6Y24O4F92SFrom the FDA Global Substance Registration System, the registry that assigns every substance the FDA tracks a unique identifier.
Frequently asked questions
Is Bremelanotide FDA-approved?
Yes. Bremelanotide holds FDA approval and is marketed in the US. Approval covers the specific uses, doses and forms on the FDA label, not every use it is sold or discussed for.
How much clinical research is there on Bremelanotide?
10 studies are registered on ClinicalTrials.gov with Bremelanotide as an intervention, 9 of them completed. The highest phase reached is Phase 4. Registration counts research activity, not proven benefit.
What brand names is Bremelanotide sold under?
FDA records list VYLEESI (AUTOINJECTOR). Brand availability changes over time, and some applications on file are marked discontinued.
Where does the information on this page come from?
Four FDA and NIH sources: Drugs@FDA for approval records, the FDA Orange Book for patents and exclusivity, the FDA Global Substance Registration System for molecular identity, and ClinicalTrials.gov for trial counts. Each is refreshed on a schedule and the date above shows the last refresh.
Sources: Drugs@FDA, FDA Orange Book, FDA Global Substance Registration System and ClinicalTrials.gov. Last refreshed 2026-10-16.