Setmelanotide — Hyped or Proven?

What Setmelanotide is

Setmelanotide is an MC4 receptor agonist used in specific rare obesity syndromes and sits outside the GLP-1 lane while still shaping obesity-drug discussions.

Setmelanotide is grouped under Fat Loss + GLP-1s / Approved / Clinical on PeptideFactCheck because it matters because it shows obesity pharmacology is not just a GLP-1 story.

The useful starting point is to separate the molecule itself from the internet story around it. It matters because it shows obesity pharmacology is not just a GLP-1 story.

Why people keep looking it up

It matters because it shows obesity pharmacology is not just a GLP-1 story.

Setmelanotide is an MC4 receptor agonist used in specific rare obesity syndromes and sits outside the GLP-1 lane while still shaping obesity-drug discussions.

Setmelanotide tends to stay in the conversation because it touches a familiar public theme: mc4 receptor, appetite regulation, and rare obesity syndromes. That makes it easy for the claim to travel faster than the evidence.

What the evidence can support right now

Approved peptide therapy with strong indication-specific evidence.

Human clinical evidence and labeling support specific approved genetic-obesity indications.

Mechanistic support aligns with melanocortin appetite-regulation biology.

Why this page carries the current tier: Approved peptide therapy with strong indication-specific evidence.

The current seed trail for Setmelanotide is pulling from 1 labels source, 1 regulatory source, and 1 literature source.

Safety, limits, and regulatory context

Its approved niche should not be blurred into broad mainstream weight-loss claims.

FDA-approved setmelanotide products exist for specific labeled uses.

Editorial boundary: PeptideFactCheck does not publish dosing, cycling, sourcing, injection, or administration instructions for Setmelanotide. The job here is to explain the public claim, the mechanism story, the evidence strength, and the current limits.

Molecular and identifier data

The current PubChem match for Setmelanotide is CID 11993702. That gives the page a source-backed chemistry record rather than a placeholder identifier block.

PubChem CID: 11993702
Formula: C49H68N18O9S2
Molecular weight: 1117.3
InChIKey: HDHDTKMUACZDAA-PHNIDTBTSA-N

Matched synonyms include Setmelanotide, 920014-72-8, RM-493, BIM-22493, Setmelanotida, N7T15V1FUY, (4R,7S,10S,13R,16S,19R,22R)-22-[[(2S)-2-acetamido-5-(diaminomethylideneamino)pentanoyl]amino]-13-benzyl-10-[3-(diaminomethylideneamino)propyl]-16-(1H-imidazol-5-ylmethyl)-7-(1H-indol-3-ylmethyl)-19-methyl-6,9,12,15,18,21-hexaoxo-1,2-dithia-5,8,11,14,17,20-hexazacyclotricosane-4-carboxamide, Setmelanotidum.

Open PubChem record

Clinical trial snapshot

The current ClinicalTrials.gov intervention query for Setmelanotide returns 26 study records. This does not prove efficacy by itself, but it does show whether the peptide is showing up in a formal trial registry rather than only in forums or vendor copy.

Long Term Extension Trial of SetmelanotideNCT03651765 | COMPLETED | PHASE2, PHASE3Rhythm Pharmaceuticals, Inc. | first posted 2018-08-29Open trial A Phase 1 Study to Evaluate the Pharmacokinetics of Setmelanotide in Subjects With Varying Degrees of Renal ImpairmentNCT04348175 | COMPLETED | PHASE1Rhythm Pharmaceuticals, Inc. | first posted 2020-04-16Open trial A Study of Setmelanotide in Patients With Prader-Willi SyndromeNCT06772597 | ACTIVE_NOT_RECRUITING | PHASE2Rhythm Pharmaceuticals, Inc. | first posted 2025-01-13Open trial Gastric Sleeve-Induced Weight Loss on Shortness of Breath in ObesityNCT05812183 | WITHDRAWN | PHASE4University of California, Los Angeles | first posted 2023-04-13Open trial Setmelanotide in a Single Patient With Partial LipodystrophyNCT03262610 | COMPLETED | PHASE2Rhythm Pharmaceuticals, Inc. | first posted 2017-08-25Open trial

Literature snapshot

The current PubMed query for Setmelanotide returns 215 results. The articles below are a quick literature surface so the page shows actual papers instead of only generic evidence labels.

Current Treatments for Patients with Genetic Obesity.Journal of clinical research in pediatric endocrinology | 2023 May 29Faccioli N, Poitou C, Clément K, Dubern B | DOI 10.4274/jcrpe.galenos.2023.2023-3-2Open citation Approach to Obesity Treatment in Primary Care: A Review.JAMA internal medicine | 2024 Jul 1Yanovski SZ, Yanovski JA | DOI 10.1001/jamainternmed.2023.8526Open citation Setmelanotide: First Approval.Drugs | 2021 FebMarkham A | DOI 10.1007/s40265-021-01470-9Open citation 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 DecHaqq AM, Chung WK, Dollfus H, Haws RM | DOI 10.1016/S2213-8587(22)00277-7Open citation 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.The lancet. Diabetes & endocrinology | 2020 DecClément K, van den Akker E, Argente J, Bahm A | DOI 10.1016/S2213-8587(20)30364-8Open citation

Label and regulatory records

For approved or clinically developed peptides, the page now pulls in official labeling and FDA-facing records where they exist. That makes the regulatory section materially more useful than a generic approved or not-approved tag.

Brand names: Imcivree
Generic names: SETMELANOTIDE
Routes: SUBCUTANEOUS
Application numbers: NDA213793

Indications and usage. 1 INDICATIONS AND USAGE IMCIVREE is indicated to reduce excess body weight and maintain weight reduction long term in adults and pediatric patients aged [ see Dosage and Administration (2.1) ]: 4 years and older with acquired hypothalamic obesity (HO) 2 years and older with syndromic or monogenic obesity due to: o Bardet-Biedl syndrome (BBS) o Pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type...

Warnings and cautions. 5 WARNINGS AND PRECAUTIONS Disturbance in Sexual Arousal: Spontaneous penile erections in males and sexual adverse reactions in females have occurred. Inform patients that these events may occur and instruct patients who have an erection lasting longer than 4 hours to seek emergency medical attention. ( 5.1 ) Depression and Suicidal Ideation: Depression and suicidal ideation have occurred. Monitor patients for new o...

Contraindications. 4 CONTRAINDICATIONS IMCIVREE is contraindicated in patients with a prior serious hypersensitivity reaction to setmelanotide or any of the excipients in IMCIVREE. Serious hypersensitivity reactions have included anaphylaxis [see Warnings and Precautions (5.3)]. Prior serious hypersensitivity to setmelanotide or any of the excipients in IMCIVREE ( 4 )

IMCIVREE (SETMELANOTIDE) SOLUTION [RHYTHM PHARMACEUTICALS, INC]Apr 02, 202670c3ccf7-4df0-4c75-ba07-fede9970c8d9Open label

NDA213793RHYTHM | submission APIMCIVREE | SOLUTION | SUBCUTANEOUSOpen FDA file

Source trail

Each linked source is shown directly so the page can be audited. The page now combines its editorial seed trail with automated official-source enrichment generated on 2026-04-24 from PubChem, ClinicalTrials.gov, PubMed, DailyMed, openFDA label, and Drugs@FDA.

DailyMed label searchLabelUsed here for official marketed labeling, indications, route, and warnings.Open source FDA Orange BookRegulatoryUsed here for approval, Orange Book, or broader regulatory-status context.Open source PubMed literature searchCitationUsed here to check published human studies, reviews, and preclinical literature.Open source

Safety noteThis content is educational only and does not replace medical advice. Peptide use may carry risks and should be discussed with a qualified medical professional.