SETM

Setmelanotide

A cyclic eight-amino-acid peptide analogue of alpha-melanocyte-stimulating hormone, closed through a disulfide bridge. It is an agonist at the melanocortin-4 receptor, and is described in the literature as selective for that receptor rather than acting across the melanocortin family the way the melanotan analogues do.

Setmelanotide has 25 registered human studies on ClinicalTrials.gov, reaching phase 4, covering 1,828 planned or enrolled participants across the 24 studies that published a figure. An FDA-approved product contains SetmelanotideIMCIVREE (NDA213793). 203 papers naming it were published in the last ten years.

Collected 2026-08-02 from ClinicalTrials.gov and Drugs@FDA. Counts include only trials whose registered intervention names Setmelanotide; the registry search is fuzzy, so every match is re-checked. None of this says whether Setmelanotide works or is safe.

FDA status

Approved

Human studies

25

Furthest phase

Phase 4

Papers, 10 yr

203

Readership

972

monthly average, Feb–Jul 2026

Tracking since 2026-08-02 · About this data

What has actually been tested in humans

A

An approved product exists

25

Registered human studies

Phase 4

Furthest phase reached

1,828

Planned or enrolled participants, across 24 studies that published a figure

Approved

FDA-approved product — IMCIVREE

27 loose registry matches were checked and 25 confirmed — 2 named something else and were discarded. We count a study only when Setmelanotide is named as an intervention in it.

Registered means registered — not that the study finished, and not that it found anything. The grade is mechanical: it is computed from the registry and the FDA record alone, and it grades how much is known, never whether a compound is good or safe. Collected 2026-08-02 from ClinicalTrials.gov and Drugs@FDA. Check the query.

What Setmelanotide is, and what it has been studied for

Setmelanotide is classified by ChEMBL as a protein, and appears in trial registrations under BIM-22493 and RM-493. Its FDA substance identifier is N7T15V1FUY.

Across 25 registered trials, it has been studied in Obesity, Genetic Obesity, Hypothalamic Obesity and Overweight. A condition here is what a sponsor registered the trial under — it records what was investigated, not what was shown.

The trials were run by Rhythm Pharmaceuticals, Inc. and Tom Hühne among others. A named commercial sponsor means a compound is in formal development; its absence does not mean the opposite, only that no company has registered a trial under its own name.

How far it got

Setmelanotide reached Phase 4 across 25 registered trials.Phase 1First given to peoplePhase 2Looking for an effectPhase 3Tested at scalePhase 4Studied after approval

Setmelanotide reached Phase 4 across 25 registered trials.

An FDA-approved product contains Setmelanotide. Approval covers a specific product for a specific use — it is not a verdict on the molecule.

Is anyone studying Setmelanotide?

Papers published each year that name Setmelanotide in the title or abstract, with the clinical trials that started in the same year marked beneath. Ten calendar years.

01325385017181920212223242526trials
Vertical axis: papers published that year. Bar for 2026 is hatched because that year is still running.
Publications and trials naming Setmelanotide, by year
YearPublicationsTrials startedComplete year
201713Yes
201853Yes
201960Yes
2020141Yes
2021225Yes
2022231Yes
2023282Yes
2024331Yes
2025432Yes
2026481No

203 papers and 19 registered trials between 2017 and 2026. A paper counts when “Setmelanotide” appears in its title or abstract — phrase-matched, so a paper mentioning the words separately is not counted. The total is a single query over the whole window, which is why it does not equal the bars added together: PubMed files a paper under both its electronic and its print publication date, so one paper can appear in two years. Publication volume measures scientific attention, not whether a compound works: a well-studied compound can be well-studied and ineffective. Sources: PubMed and ClinicalTrials.gov · collected 2026-08-02.

Published research on Setmelanotide

203 indexed papers name Setmelanotide in their title or abstract. These are the 8 PubMed ranks most relevant. Listing a paper is not a judgement about it, and none of these is summarised here — follow the link and read what it says.

  1. Current Treatments for Patients with Genetic Obesity

    Faccioli N, Poitou C, Clément K, et al.Journal of clinical research in pediatric endocrinology2023

    PMID 3719134710.4274/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

    Haqq AM, Chung WK, Dollfus H, et al.The lancet. Diabetes & endocrinology2022

    PMID 3635661310.1016/S2213-8587(22)00277-7

  3. Evaluation of a melanocortin-4 receptor (MC4R) agonist (Setmelanotide) in MC4R deficiency

    Collet TH, Dubern B, Mokrosinski J, et al.Molecular metabolism2017

    PMID 2903173110.1016/j.molmet.2017.06.015

  4. Setmelanotide for the treatment of acquired hypothalamic obesity: a phase 2, open-label, multicentre trial

    Roth CL, Scimia C, Shoemaker AH, et al.The lancet. Diabetes & endocrinology2024

    PMID 3869718410.1016/S2213-8587(24)00087-1

  5. Setmelanotide

    2012

    PMID 39083631

  6. 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

    Clément K, van den Akker E, Argente J, et al.The lancet. Diabetes & endocrinology2020

    PMID 3313729310.1016/S2213-8587(20)30364-8

  7. Setmelanotide for the Treatment of Acquired Hypothalamic Obesity

    Miller JL, van Santen HM, Phillips SA, et al.The New England journal of medicine2026

    PMID 4241877410.1056/NEJMoa2512275

  8. Setmelanotide

    Hussain A, Farzam K2026

    PMID 36943959

Collected 2026-08-02from PubMed, phrase-matched on “Setmelanotide” in title and abstract. Run the same search.

About Setmelanotide

A cyclic eight-amino-acid peptide analogue of alpha-melanocyte-stimulating hormone, closed through a disulfide bridge. It is an agonist at the melanocortin-4 receptor, and is described in the literature as selective for that receptor rather than acting across the melanocortin family the way the melanotan analogues do.

Also known as
RM-493 · BIM-22493

Structure and mechanism only. Nothing above describes what this compound is for, and no dose appears anywhere on this page.

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