As of September 2026, setmelanotide is an approved medicine in the US and the EU for rare genetic obesity disorders. The FDA has also approved it for obesity caused by a brain tumor or its treatment. The approval trials were small, with no comparison group. A vial that did not come from a pharmacy sits outside those trials, and you cannot tell from the outside what is in it.
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What is setmelanotide?
Setmelanotide is a lab-made peptide that activates MC4R, a brain pathway that controls hunger and energy use. Rhythm Pharmaceuticals developed it for people whose severe obesity comes from rare gene changes that disrupt that pathway. The FDA first approved it in November 2020, and the EMA later granted a similar orphan-drug authorisation.
Does setmelanotide work?
For its approved uses, the FDA and the EMA reviewed the trials and approved it. Those uses are long-term weight management in rare genetic obesity disorders and, more recently, acquired hypothalamic obesity.
What we found. 3+ completed randomized trials counted on the record. 2 study rows are listed below, so the number shows with a plus sign. A third entry on the record is an FDA approval notice, and it sits in the legal section. The record's text describes the approval trials as two single-arm Phase 3 trials, in which everyone got the medicine.
| Study | Tested in | Status | What it shows |
|---|---|---|---|
| Setmelanotide in POMC or LEPR deficiency, single-arm Phase 3 trials | People | Published. The basis for the 2020 approval | Significant weight loss and less hunger in people with POMC or LEPR deficiency |
| Quality of life outcomes in two Phase 3 trials | People | Published | Reported better quality-of-life scores alongside weight loss |
Is setmelanotide safe?
The record names three key concerns: skin darkening, reactions where the medicine is given, and nausea. The people treated are very few, so the safety data come from small trials. Uncommon or long-term harms are not yet well described, and neither is how the effect holds up beyond a few years. Every line above is about the product that patients receive through medical care.
Is setmelanotide legal?
- United States
- Approved by the FDA in 2020 as Imcivree. The approval was expanded in 2022, and it has also been extended to acquired hypothalamic obesity.
- European Union
- The EMA granted an orphan-drug marketing authorisation after the US approval.
- Sport
- Not named on WADA's list. That is not clearance.
Not medical advice. Approval and sport status as of . Medical disclaimer
What is in a vial sold as setmelanotide?
The trials above tested the maker's product, approved as Imcivree. The record says it is used only by patients with confirmed genetic testing or a qualifying hypothalamic injury. It holds no sign that setmelanotide is sold outside pharmacies. If a vial reached you another way, none of those trials tested it, and the checklist lists what to ask the seller.
What don't we know?
- What uncommon harms it has. The trials were very small.
- What long-term use does. Long-term harms are not yet well described.
- Whether the effect holds beyond a few years of treatment.
- What is in any vial that did not come from a pharmacy.
The other side
The approved product reaches only patients with confirmed genetic testing or a qualifying hypothalamic injury. The trials were small because these conditions are rare, and they found significant weight loss and less hunger. The open question is the long term: uncommon harms, and how well the effect holds.
What would change this record?
- Larger and longer registry data, gathered after approval, across the growing groups of approved patients.
Three questions to ask next
- What does 'research use only' actually mean?
- How can you tell if a peptide vendor is legitimate?
- How do you read a certificate of analysis?
Ask better questions.
More questions about setmelanotide
What is setmelanotide used for?
- Long-term weight management in rare genetic obesity disorders and, more recently, acquired hypothalamic obesity, which follows a brain tumor or its treatment. The record says it is used only by patients with confirmed genetic testing or a qualifying hypothalamic injury.
Is setmelanotide approved for general weight loss?
- No. This record shows approval for rare genetic obesity disorders and for acquired hypothalamic obesity, and for no other use.
Is setmelanotide the same as Imcivree?
- Yes. Imcivree is the brand name under which the FDA approved setmelanotide in 2020. The record also lists RM-493 as another name.
What are the side effects of setmelanotide?
- The record names skin darkening, reactions where the medicine is given, and nausea as key concerns. It adds that the safety data come from small trials.
Is setmelanotide banned in sport?
- It is not named on WADA's list. That is not clearance.
Record checked on . Each source shows the date it was checked.
In the same group
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