Setmelanotide
FDA ApprovedAlso known as: Imcivree, RM-493
MetabolicLast reviewed: April 28, 2026
An MC4R (melanocortin 4 receptor) agonist FDA-approved for rare genetic obesity disorders including POMC, PCSK1, and LEPR deficiency. Represents a precision medicine approach to obesity treatment.
Mechanism of Action
Activates the MC4R pathway in the hypothalamus, restoring satiety signaling that is disrupted in specific genetic obesity conditions. Unlike GLP-1 agonists, it targets the melanocortin pathway directly.
Common Uses
- Rare genetic obesity (POMC deficiency)
- PCSK1 deficiency obesity
- LEPR deficiency obesity
Known Risks
- Skin hyperpigmentation (common)
- Injection site reactions
- Depression and suicidal ideation (boxed warning)
- Spontaneous penile erections
- Very narrow approved indication
Regulatory Status
FDA-approved as Imcivree (2020) for chronic weight management in patients 6+ years with obesity due to POMC, PCSK1, or LEPR deficiency confirmed by genetic testing. Not approved for general obesity.
Common Protocols
Protocol information is for educational reference only. Dosing varies significantly by individual, condition, and physician guidance. Always work with a licensed healthcare provider.
Subcutaneous injection
Typical Dose
1–3 mg (titrated)
Frequency
Once daily
Cycle Length
Ongoing
Only for genetically confirmed rare obesity. Requires REMS program enrollment. Not available through compounding.
Related Compounds
Research References
This information is for educational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional before starting any peptide therapy. Data is compiled from published research and regulatory sources and may not reflect the most recent developments.