Setmelanotide
Also known as: Imcivree, RM-493
At a glance
PeptiGuide dataset · reviewed Aug 2026
What it is
FDA-approved MC4R agonist peptide for defined rare obesity disorders.
Status
FDA Approved
Typical dose
2–3mg
Researched for
Genetic obesity disorders and rare metabolic conditions
Trial progress
- PrePreclinical
- IPhase I
- IIPhase II
- IIIPhase III
- IVPhase IV
- FDAFDA approved
FDA approved - FDA-approved for specific uses with established human evidence
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In plain language
- MC4R also known as Imcivree or RM-493.
- Reported by the source as FDA approved for specific rare obesity indications rather than general obesity.
- Source-described indications include BBS, POMC/PCSK1/LEPR deficiency, and acquired hypothalamic obesity.
- Reported administration is once-daily injection.
- Research focus is genetic obesity disorders and rare metabolic conditions.
How it's thought to work
Setmelanotide is reported as a melanocortin-4 receptor . The supplied mechanism evidence places MC4R downstream of leptin and POMC signaling in hypothalamic appetite regulation. For rare conditions such as POMC, PCSK1, or LEPR deficiency, the source states that upstream signaling can be impaired while MC4R remains a target; direct MC4R agonism is therefore presented as the rationale for its narrow genetic-obesity use.
What the research shows
Where the research stands
The supplied source summarizes clinical evidence as narrow but strong for rare disease populations. It reports pivotal open-label, single-arm phase 3 studies in POMC and LEPR deficiency, with at least 10% weight loss at about one year in 80% of POMC participants and 45% of LEPR participants, plus reduced hunger scores. The source also cites a randomized placebo-controlled phase 3 study for Bardet-Biedl syndrome and a 2024 VENTURE open-label study including children as young as two. Because the conditions are rare, the evidence base is described as small and indication-specific rather than broadly applicable to common obesity.
What it shows
✓ Human clinical evidence
FDA-approved for specific uses with established human evidence
△ Limitations
Use only according to approved labeling and qualified medical guidance.
Bottom line: FDA approved for specified rare obesity indications including BBS, POMC/PCSK1/LEPR deficiency, and acquired hypothalamic obesity. FDA Approved
Typical dosing
CommunityCommunity dataset2–3 mg
daily
Community-reported dosing entry for specific genetic obesity contexts; this is not dosing guidance. · Subcutaneous injection
Research dosing
Indication-specificApproved for specific uses - study doses are indication-specific
Timing & administration
Best time to take
Beginning of the day
Once daily
Food recommendation
Without regard to meals
Why this timing?
FDA prescribing information directs once-daily administration at the beginning of the day without regard to meals.
Possible side effects
Not everyone experiences these. Individual responses vary with dose, duration, and personal factors.
- Skin hyperpigmentation
- Injection-site reactions
- Nausea
- Spontaneous erections in males
- Priapism risk
- Depression risk
- Headache
Not everyone experiences side effects, and severity can vary by context, purity, route, and individual health factors.
Sources
Frequently asked questions
Sequence
Ac-Arg-Cys(1)-D-Ala-His-D-Phe-Arg-Trp-Cys(1)-NH2; Cys2-Cys8 disulfide
One open dataset
Every fact on this page - doses, side effects, references - comes from the same PeptiGuide dataset that powers the Tracker, Compare, and the Lab.
Browse the datasetEducational resource, not medical advice. Talk to your clinician before acting on anything here.
Community discussion
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