Weight Loss FDA Approved

Setmelanotide

An FDA-approved MC4R agonist marketed as Imcivree for specific rare genetic forms of obesity.

MC4RFDA ApprovedRare DiseaseObesityImcivree

Also referenced as: Imcivree, RM-493

Also appears in: Hormone

Status
FDA Approved

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

Category
Weight Loss

Primary lane: Weight Loss. Also surfaces under Hormone for browsing and discovery.

Aliases
2

Imcivree, RM-493

Signal depth
High

FDA label signal · 30 trials · 205 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 205 PubMed-indexed publications and holds an FDA drug label. 14 trials have posted results.

FAERS (approved drug): 58
Human data
Approved drug
Trial quality
Randomized
Outcomes
Clinical outcomes
Replication
Multiple trials
Literature
Top-tier journals
PHASE4 · Randomized Study of Setmelanotide Effects on QTc (Corrected QT) Interval in Healthy Participants PHASE3 · Randomized EMANATE: A Study of Setmelanotide in Patients With Specific Gene Variants in the MC4R Pathway PHASE2/PHASE3 Long Term Extension Trial of Setmelanotide The Lancet Diabetes & Endocrinology · 467 citations Efficacy 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 · 302 citations Evaluation of a melanocortin-4 receptor (MC4R) agonist (Setmelanotide) in MC4R deficiency The Lancet Diabetes & Endocrinology · 185 citations Efficacy 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 2026-07-13 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.