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Setmelanotide: FDA status and clinical evidence
Setmelanotide is approved by the FDA and is on the US market, first approved November 25, 2020, under 1 application. 27 studies are registered on ClinicalTrials.gov, reaching Phase 4. 3 unexpired patents are listed in the Orange Book.
FDA approval status
FDA review documents
Clinical evidence
By phase
Patents and generic availability
Molecular identity
N7T15V1FUYFrom the FDA Global Substance Registration System, the registry that assigns every substance the FDA tracks a unique identifier.
Frequently asked questions
Is Setmelanotide FDA-approved?
Yes. Setmelanotide 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 Setmelanotide?
27 studies are registered on ClinicalTrials.gov with Setmelanotide as an intervention, 19 of them completed. The highest phase reached is Phase 4. Registration counts research activity, not proven benefit.
What brand names is Setmelanotide sold under?
FDA records list IMCIVREE. 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.