Is Setmelanotide legal in the US?
Yes, FDA approved for weight control in obesity from certain gene faults, Bardet-Biedl syndrome, and brain-injury obesity.
Setmelanotide is FDA-approved as Imcivree for chronic weight management in patients aged 2 and older with obesity due to POMC, PCSK1 or LEPR deficiency (first approved November 2020), Bardet-Biedl syndrome (2022), and, since March 19, 2026, acquired hypothalamic obesity in patients aged 4 and older. It is not approved for common obesity. 23
Patients aged 2 and older with obesity caused by genetically confirmed POMC, PCSK1 or LEPR deficiency, or by Bardet-Biedl syndrome. Also patients aged 4 and older with obesity caused by hypothalamic damage. Variants classed as benign or likely benign do not qualify. Variants of uncertain significance do. It is not approved for obesity without one of these causes. 2
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More on Setmelanotide
Citations
- Clément 2020, Lancet Diabetes Endocrinol: setmelanotide in POMC and LEPR deficiency obesity, two open-label phase 3 trials doi.org
- Imcivree (setmelanotide) prescribing information, FDA, 2026 accessdata.fda.gov
- Contemporary Pediatrics, March 2026: FDA approves setmelanotide for acquired hypothalamic obesity (TRANSCEND results) contemporarypediatrics.com
Reference information only, not medical advice. Drawn from the Setmelanotide article, fact-checked against the cited sources. No dosing anywhere on this site.