Evidence reference only. Not medical advice, not a dosing guide, and not a recommendation to use any drug.
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Setmelanotide

MARKETED

Melanocortin-4 receptor agonist

1
graded results
0
ongoing records
1
effect domains
Evidence spread
High evidence 0Moderate evidence 1Low evidence 0Very low evidence 0

Setmelanotide has a current marketed status in the scoped regulatory record below. Results describe observations and do not provide treatment advice.

Dated status sources

MARKETED United States; Specified monogenic, syndromic and acquired hypothalamic obesity indications; Subcutaneous injection; as of 2026-07-13. US Food and Drug Administration

The grade rates how strong the evidence is, not how good or safe the drug is. A low or very-low grade means the evidence is thin, not that an effect is harmful or ruled out.

Thin or bounded evidence here means uncertainty remains visible. It is not evidence that an effect has been ruled out.
Setmelanotide MARKETED
weight-loss Decrease
Moderate evidence

In severe obesity from POMC or LEPR deficiency, ~1 year of setmelanotide produced significant weight loss and reduced hunger: >=10% weight loss in 80% (8/10) of...

Clement et al., Lancet Diabetes Endocrinol 2020 Source
Full findingIn severe obesity from POMC or LEPR deficiency, ~1 year of setmelanotide produced significant weight loss and reduced hunger: >=10% weight loss in 80% (8/10) of POMC-deficiency and 45% (5/11) of LEPR-deficiency participants. Marketed (Imcivree) for genetic MC4R-pathway obesity and Bardet-Biedl syndrome; positive in acquired hypothalamic obesity and ages 2-5 (VENTURE).
PopulationSingle-arm open-label multicentre phase 3, POMC and LEPR deficiency, participants aged >=6y; ~1-year endpoint
Fundingindustry - Rhythm Pharmaceuticals (setmelanotide; disclosed)