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IndexedBuilt automatically from public databases on 2026-09-30. Not yet hand-reviewed by PLOBT.How this works →

Setmelanotide

FDA approved · Rx

MC4R agonist peptide

Also known as: Imcivree, RM-493, BIM-22493, Setmelanotida, Setmelanotidum, Setmelanotide (RM-493), orb1708548, GLXC-21144

Evidence score
91/ 100
Strong evidence

Strong, human-grade evidence

  • Regulatory standing. FDA-approved prescription medicine
  • Human trials. Backed by controlled human studies
  • Registered human trials. 27 registered studies on ClinicalTrials.gov, most advanced Phase 4
  • 2 cited sources. Includes primary / regulatory sources

Computed with the same four public criteria as every profile. The human-evidence grade on an indexed profile is set automatically and may change when it is hand-reviewed. It is not a safety score, not a purity rating, and not medical advice, and not a claim that this compound treats, cures, or prevents any condition.

What it is

Setmelanotide, sold as Imcivree, is a synthetic cyclic peptide that activates the melanocortin-4 receptor (MC4R) in the brain. This receptor is part of a pathway that helps regulate hunger and energy use, and setmelanotide is thought to restore signaling when genetic defects upstream in that pathway disrupt it.

What the evidence shows

Automatic summaryHuman trials

Setmelanotide is FDA approved for chronic weight management in people with obesity due to certain rare genetic conditions, including POMC, PCSK1, or LEPR deficiency and Bardet-Biedl syndrome. It is not established for common obesity without these specific genetic causes, and it has been studied in 27 registered human trials.

Key facts

Molecular formula
C49H68N18O9S2
Molecular weight
1117.3 g/mol
FDA approval
Confirmed on openFDA

Registered human trials

Live from ClinicalTrials.gov, refreshed daily.

27registered studies
Phase 4most advanced phase
19completed (sample)
2recruiting (sample)

Open-Label Study of Setmelanotide in Hypothalamic Obesity

Phase 2CompletedNCT04725240

Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RM-493 Administered to Healthy, Obese, Non-diabetic Volunteers

Phase 1CompletedNCT02431442

Phase 3 Crossover Trial of Two Formulations of Setmelanotide in Participants With Specific Gene Defects in the MC4R Pathway

Phase 3CompletedNCT05194124

A Phase 1 Study to Evaluate the Pharmacokinetics of Setmelanotide in Subjects With Varying Degrees of Renal Impairment

Phase 1CompletedNCT04348175

Published literature

Live from Europe PMC. This is how much has been published, not how much is proven in humans.

227papers referencing Setmelanotide

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.

Lancet Diabetes Endocrinol2020

Proopiomelanocortin Deficiency Treated with a Melanocortin-4 Receptor Agonist.

N Engl J Med2016

Pharmacotherapy of obesity: an update on the available medications and drugs under investigation.

EClinicalMedicine2023

MC4R agonism promotes durable weight loss in patients with leptin receptor deficiency.

Nat Med2018

Sources

Risks, side effects and study doses are only published on hand-reviewed profiles. Want this one reviewed, or spotted something wrong? Tell us.