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Public product evidence1 certificate record mentioning this compound or product name1 provider-linked · 1 exact product matches

Status

FDA Approved

This peptide maps to at least one regulated medical product or label context in the United States.

Research area

Metabolic / incretin research

Primary research area: Metabolic. Also surfaces under Hormone for browsing and discovery.

Aliases

Imcivree, RM-493

Signal depth

High

FDA label signal · 30 trials · 217 PubMed results

Established

Research evidence

Setmelanotide is an FDA-approved medicine with substantial published trial evidence. Note that research-market products sold under this name are not the approved medicine and are not held to the same manufacturing or labeling standards.

Setmelanotide has 25 name-matched clinical trials (highest phase: Phase 4) and 218 PubMed-indexed publications and holds an FDA drug label. 14 trials have posted results.

FAERS (approved drug): 59

Human data

Approved drug

Trial quality

Randomized

Outcomes

Clinical outcomes

Replication

Meta-analysis

Literature

Top-tier journals

PHASE4 · RandomizedStudy of Setmelanotide Effects on QTc (Corrected QT) Interval in Healthy Participants PHASE3 · RandomizedEMANATE: A Study of Setmelanotide in Patients With Specific Gene Variants in the MC4R Pathway PHASE2/PHASE3Long Term Extension Trial of Setmelanotide The Lancet Diabetes & Endocrinology · 475 citationsEfficacy and safety of setmelanotide, an MC4R agonist, in individuals with severe obesity due to LEPR or POMC deficiency: single-arm, open-label, multicentre, phase 3 trials Molecular Metabolism · 308 citationsEvaluation of a melanocortin-4 receptor (MC4R) agonist (Setmelanotide) in MC4R deficiency The Lancet Diabetes & Endocrinology · 197 citationsEfficacy and safety of setmelanotide, a melanocortin-4 receptor agonist, in patients with Bardet-Biedl syndrome and Alström syndrome: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial with an open-label period

Evidence history

Re-checked nightly against the registries — tracked since 2026-07-09. No band changes yet.

Grades evidence strength, not efficacy or safety. Research-use context; not medical advice. Graded 2026-09-08 from PubMed, ClinicalTrials.gov, ISRCTN, openFDA, Health Canada, and OpenAlex — computed deterministically and refreshed nightly, with a retraction check. How we grade →

What setmelanotide is

Setmelanotide is an MC4R agonist sold as Imcivree, and it is already an FDA-approved treatment for specific rare genetic and syndromic forms of obesity.

Why it matters

It gives the library a much-needed example of an obesity peptide that is both approved and highly specialized. Unlike semaglutide or tirzepatide, setmelanotide is not meant for general obesity.

Regulatory context

Setmelanotide is FDA approved in the United States for specific labeled indications tied to rare genetic obesity syndromes.

Practical reading note

Setmelanotide is a good reminder that “obesity peptide” does not always mean broad consumer use. Some of the most important drugs in the category are highly indication-specific.