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 Setmelanotide — IMCIVREE (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
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.
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.
| Year | Publications | Trials started | Complete year |
|---|---|---|---|
| 2017 | 1 | 3 | Yes |
| 2018 | 5 | 3 | Yes |
| 2019 | 6 | 0 | Yes |
| 2020 | 14 | 1 | Yes |
| 2021 | 22 | 5 | Yes |
| 2022 | 23 | 1 | Yes |
| 2023 | 28 | 2 | Yes |
| 2024 | 33 | 1 | Yes |
| 2025 | 43 | 2 | Yes |
| 2026 | 48 | 1 | No |
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.
- Current Treatments for Patients with Genetic Obesity
- 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
- Evaluation of a melanocortin-4 receptor (MC4R) agonist (Setmelanotide) in MC4R deficiency
- Setmelanotide for the treatment of acquired hypothalamic obesity: a phase 2, open-label, multicentre trial
- 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
- Setmelanotide for the Treatment of Acquired Hypothalamic Obesity
- Setmelanotide
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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