Peptide · Fact sheet
Setmelanotide
Also known as Imcivree · RM-493
Imcivree has FDA-approved weight-reduction indications for acquired hypothalamic obesity from age 4 and specified genetic obesity conditions from age 2. It is not approved for general obesity.
What is Setmelanotide?
Setmelanotide is a synthetic cyclic peptide that activates the melanocortin-4 receptor, a key part of the brain pathway regulating hunger and body weight.
The approved populations have specific genetic or acquired hypothalamic disorders; results cannot be transferred to common polygenic obesity.
Benefits people look for
It shows why the cause of obesity matters: the approved uses involve specific genetic conditions or acquired hypothalamic injury, rather than general weight management.
Research continues in additional rare syndromic forms of obesity, but each requires its own evidence and regulatory review.
What the evidence supports
- Pivotal studies observed clinically important weight reduction in some people with rare MC4-pathway disorders.
- The treatment can also reduce hunger in responsive patients, but response varies by genetic condition and person.
All research areas
- POMC, PCSK1, and LEPR deficiency obesity
- Bardet-Biedl syndrome
- Other rare hypothalamic or syndromic obesity conditions
- Hunger and hyperphagia outcomes
- Additional genetically or anatomically defined obesity syndromes
Anecdotal reports & lived experiences
Reports describe what someone noticed. They cannot establish cause, typical results, or how often a side effect happens.
No attributable personal reports are summarized here yet. The benefits above describe research interests; the side effects below come from the cited medical sources.
We do not fill this gap with unsourced testimonials or estimated success rates.
Side effects & risks
- The label warns about depression and suicidal thinking, sexual-arousal effects, serious hypersensitivity, and skin darkening or changes in existing moles.
- Common adverse reactions include skin hyperpigmentation, injection-site reactions, nausea, headache, gastrointestinal symptoms, depression, and spontaneous erections.
- The label adds warnings about acute adrenal insufficiency in acquired hypothalamic obesity and sodium imbalance when central diabetes insipidus is also present.
This is a summary of the cited evidence, not a complete product label. A lack of human safety data does not establish safety.
Clinical research: how strong is it?
Strong human evidence for approved usesHuman trials support weight and hunger outcomes in small rare-disease populations. The evidence is meaningful for those exact pathway disorders and does not establish benefit for common obesity.
Selected research to read
Pivotal human trials in severe obesity caused by POMC or LEPR deficiency.
Randomized trial supporting the Bardet-Biedl syndrome indication.
What do the human studies show?
Selected research questions, not a complete inventory of indications or trials. Source checking is not independent clinical review. How we read the evidence.
For this question, the FDA decision below is the main source. It explains the evidence behind the approval and its limits.
What these results can and cannot tell us
Does Imcivree include acquired hypothalamic obesity?
The label distinguishes acquired hypothalamic obesity from age 4 and specified genetic conditions from age 2.
Limit: Approval does not extend to general obesity or every genetic variant.
Check the sources: FDA Imcivree prescribing information (checked 2026-09-18)
What is approved, and for whom?
United States records selected for the questions above; not a complete label or a worldwide approval inventory.
Imcivree: Acquired hypothalamic obesity
Subcutaneous injection · Adults and children aged at least 4 with acquired hypothalamic obesity
approved — Not an indication for general obesity. Acquired hypothalamic obesity has specific warnings.
Exact linked source and stated indication only; not an exhaustive regulatory search.
Read the original source · Source checked: 2026-09-18
Imcivree: Specified genetic obesity
Subcutaneous injection · Age 2+ with BBS or specified genetically confirmed POMC, PCSK1 or LEPR deficiency
approved — Genetic eligibility and limitations are defined in the label; not all variants qualify.
Exact linked source and stated indication only; not an exhaustive regulatory search.
Read the original source · Source checked: 2026-09-18
Compare research questions · Submit a source-based correction
FDA approval & research status
The Imcivree label covers acquired hypothalamic obesity from age 4, and specified POMC, PCSK1 or LEPR deficiency or Bardet-Biedl syndrome from age 2. These are distinct populations; general obesity remains outside the indication.
Approved uses covered here
- Long-term reduction of excess body weight in eligible people age 2 and older with specified POMC, PCSK1, or LEPR deficiency or Bardet-Biedl syndrome
- Weight reduction and maintenance in acquired hypothalamic obesity from age 4
FDA approved for rare genetic obesity indications
Imcivree has distinct age and diagnosis criteria: acquired hypothalamic obesity from age 4, and specified genetic obesity conditions from age 2. General obesity is not included.
This summarizes the cited product or research record. Trial phases do not establish successful completion of earlier stages, and a stopped program is not ongoing development. Approval applies only to the labeled product, use and population.
What we still don’t know
- Long-term outcomes beginning in very young children
- Which additional rare obesity disorders will respond
- How benefits and risks compare across the small, genetically distinct approved groups
- Effects in common obesity, where the drug is not indicated
The takeaway
Setmelanotide targets a particular hunger-signaling pathway. Its approved use depends on the exact diagnosis and labeled population, including specified genetic conditions and acquired hypothalamic obesity.
Sources & further reading
Medical evidence and regulatory sources are listed here. Personal reports are linked separately in the experiences section.
- 1fdaFDA prescribing information: Imcivree
Distinct acquired hypothalamic and genetic obesity indications, age limits and warnings.
- 2fdaFDA orphan-drug approvals: setmelanotide
Official approval history for the rare genetic obesity indications.
- 3pubmedPhase 3 POMC and LEPR deficiency trials
Pivotal human trials in severe obesity caused by POMC or LEPR deficiency.
- 4pubmedPhase 3 Bardet-Biedl syndrome trial
Randomized trial supporting the Bardet-Biedl syndrome indication.