Setmelanotide
Also known as Imcivree, RM-493
A real medicine for a few rare causes of obesity. It darkens the skin and moles in most people who take it, and its trials only included people with those rare conditions.
Information only. Not medical advice. Talk to a doctor before you start, stop or change anything.
What people claim
- Switches off hunger for anyone
- The next Ozempic
What the evidence shows
- It is approved only for obesity caused by specific rare genetic conditions or damage to the hypothalamus.[1]
- In phase 3 trials, 8 of 10 people with POMC deficiency and 5 of 11 with LEPR deficiency lost at least 10% of body weight at about a year.[2]
- Those trials were small, open-label and funded by the manufacturer. They enrolled only people with these conditions.[2]
Known risks
- Skin darkening happened in the majority of treated patients. It can also darken existing moles and cause new ones, so a full skin check is advised before and during treatment.[1]
- Label warnings include depression and suicidal thoughts, sexual side effects and serious allergic reactions.[1]
- Injection site reactions and nausea were common in trials.[2]
Reported side effects
Moderated user reports are not open yet, so nothing is shown here. They will be labelled as unverified personal accounts.
Legal status
A summary, not legal advice. Rules change, and sport bans are separate.
Prescription
FDA approved for specific rare genetic and hypothalamic obesity.[1]
Prescription
Licensed for specific rare genetic and hypothalamic obesity.
Not approved
We found no registered product on the ARTG when checked.
Prescription
Authorised through the European Medicines Agency for rare genetic obesity.
Sources
- 1.Imcivree US prescribing informationUS FDA, 2026
- 2.Efficacy and safety of setmelanotide in severe obesity due to LEPR or POMC deficiency: phase 3 trialsLancet Diabetes and Endocrinology, 2020
Profile last checked 7 Nov 2026.