ML-SYS / 2026.07NON-CLINICAL RESEARCH MATERIALSORIGIN DECLARED BY LOT

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RM-MCS / Melanocortin signalling

Setmelanotide

Also known as: RM-493 · MC4 receptor agonist

Approved comparator exists

Grade describes the published research on the molecule. It is not a quality score, a safety score, or a release state.

What this is

Setmelanotide is a cyclic peptide analog targeting MC4R. Its evidence base is tied to specific, genetically defined pathways and should not be generalized to other melanocortin compounds.

Evidence position

An FDA-labeled comparator and phase 3 studies support Grade A within that narrow boundary.

What the record does not establish

The comparator record does not verify a third-party sample, and it does not transfer evidence to melanotan or bremelanotide.

Sources

  • 01
    Imcivree prescribing informationDailyMed / U.S. National Library of Medicine
    Shows
    Current U.S. label, molecular description and indication boundary
    Does not show
    Approval is limited to the finished product and labeled populations
  • 02
    Setmelanotide phase 3 POMC and LEPR trialsPubMed
    Shows
    Human phase 3 evidence in genetically defined cohorts
    Does not show
    Small, selected populations; not general-purpose outcome evidence

External database index

LIVE DATABASE INDEX / SEPARATE FROM CURATED EVIDENCE

Records below come directly from public scientific databases. They help find relevant material, but do not affect the evidence grade until they are matched to the molecule and added to the curated source list.

PUBMED / FOUND RECORDS

  1. Current Treatments for Patients with Genetic Obesity.Journal of clinical research in pediatric endocrinology / 2023 May 29PMID 37191347 / DOI 10.4274/jcrpe.galenos.2023.2023-3-2
  2. 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.The lancet. Diabetes & endocrinology / 2022 DecPMID 36356613 / DOI 10.1016/S2213-8587(22)00277-7
  3. Pharmacotherapy for Obesity: Recent Updates.Clinical pharmacology : advances and applications / 2025PMID 40995421 / DOI 10.2147/CPAA.S497904
  4. Evaluation of a melanocortin-4 receptor (MC4R) agonist (Setmelanotide) in MC4R deficiency.Molecular metabolism / 2017 OctPMID 29031731 / DOI 10.1016/j.molmet.2017.06.015
  5. Setmelanotide for the treatment of acquired hypothalamic obesity: a phase 2, open-label, multicentre trial.The lancet. Diabetes & endocrinology / 2024 JunPMID 38697184 / DOI 10.1016/S2213-8587(24)00087-1

CLINICALTRIALS.GOV / FOUND RECORDS

  1. EMANATE: A Study of Setmelanotide in Patients With Specific Gene Variants in the MC4R PathwayACTIVE_NOT_RECRUITING / PHASE3 / Rhythm Pharmaceuticals, Inc.NCT05093634 / DIRECT intervention MATCH: Setmelanotide
  2. Phase 1b/2a Study to Evaluate Safety and Efficacy of Setmelanotide in Obese PatientsCOMPLETED / PHASE1, PHASE2 / Rhythm Pharmaceuticals, Inc.NCT02041195 / DIRECT intervention MATCH: Setmelanotide
  3. Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RM-493 Administered to Healthy, Obese, Non-diabetic VolunteersCOMPLETED / PHASE1 / Rhythm Pharmaceuticals, Inc.NCT02431442 / DIRECT intervention MATCH: Setmelanotide
  4. A Phase 1 Study to Evaluate the Pharmacokinetics of Setmelanotide in Subjects With Varying Degrees of Renal ImpairmentCOMPLETED / PHASE1 / Rhythm Pharmaceuticals, Inc.NCT04348175 / DIRECT intervention MATCH: Setmelanotide
  5. Real-World Effects of MC4R Agonist Therapy in BBS and Severe Genetic ObesityRECRUITING / PHASE4 / Tom HühneNCT07674290 / DIRECT intervention MATCH: Setmelanotide

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