Hormonal & Sexual Health

Setmelanotide

Last updated 12 August 2026

Evidence on fileFDA-approved · 2 randomised human trials

Strongest sourceEfficacy and safety of setmelanotide, an MC4R agonist, in individuals with severe obesity due to LEPR or POMC… (randomised human trial)

Regulatory status

Approved by the FDA. Marketed as IMCIVREE. Earliest approval 2020-11-25. Application NDA213793.

An approval grades as rung 1 on this site, because 21 CFR 314.126 requires adequate and well-controlled human investigations and one cannot be granted without them. It covers specific indications and doses, though, and does not transfer to other uses of the same molecule.

Dosing on file unverified

Start: 0.5 mg QD × 2 weeks; Target: 3 mg QD (adults/peds ≥6 yrs); Titrate 1.5-3.0 mg by age/weight

Carried from a source that labels it unverified, and reproduced with that label attached. A record of what is reported, not a recommendation. No citation on this page establishes it.

Literature on file 3

human RCT
Efficacy and safety of setmelanotide, an MC4R agonist, in individuals with severe obesity due to LEPR or POMC deficiency (The Lancet Diabetes & Endocrinology 2020, cited 442x) graded on: a phase 2b/3 trial — the indexed publication type — “Trial, Phase III”
human RCT
Efficacy and safety of setmelanotide, a melanocortin-4 receptor agonist, in patients with Bardet-Biedl syndrome and Alstrom syndrome (The Lancet Diabetes & Endocrinology 2022, cited 183x) graded on: names a randomised controlled trial — the indexed publication type — “Randomized Controlled”
human RCT
FDA approval NDA213793 graded on: an FDA approval (NDA213793), which requires adequate and well-controlled human investigations — “NDA213793”

Identity

Space-filling 3D model of Setmelanotide, carbon grey, nitrogen blue, oxygen red — Built from the SMILES on this record — the atoms, bonds and stereochemistry are exact. The shape is **one computed low-energy pose**, not a measured structure: a flexible peptide in solution has no single conformation. The skeletal formula below claims connectivity and nothing more, which is what we actually know.

2D chemical structure of Setmelanotide — Built from the SMILES on this record — the atoms, bonds and stereochemistry are exact. The shape is **one computed low-energy pose**, not a measured structure: a flexible peptide in solution has no single conformation. The skeletal formula below claims connectivity and nothing more, which is what we actually know.

Molecular weight: 1117.3
Molecular formula: C49H68N18O9S2
CAS number: 920014-72-8
PubChem CID: 11993702
InChI key: HDHDTKMUACZDAA-PHNIDTBTSA-N
Sequence: RCAHFRWC
SMILES: C[C@@H]1C(=O)N[C@H](C(=O)N[C@@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@@H](CSSC[C@@H](C(=O)N1)NC(=O)[C@H](CCCN=C(N)N)NC(=O)C)C(=O)N)CC2=CNC3=CC=CC=C32)CCCN=C(N)N)CC4=CC=CC=C4)CC5=CN=CN5
InChI: InChI=1S/C49H68N18O9S2/c1-26-41(70)63-37(20-30-22-55-25-59-30)46(75)64-35(18-28-10-4-3-5-11-28)44(73)62-34(15-9-17-57-49(53)54)43(72)65-36(19-29-21-58-32-13-7-6-12-31(29)32)45(74)66-38(40(50)69)23-77-78-24-39(47(76)60-26)67-42(71)33(61-27(2)68)14-8-16-56-48(51)52/h3-7,10-13,21-22,25-26,33-39,58H,8-9,14-20,23-24H2,1-2H3,(H2,50,69)(H,55,59)(H,60,76)(H,61,68)(H,62,73)(H,63,70)(H,64,75)(H,65,72)(H,66,74)(H,67,71)(H4,51,52,56)(H4,53,54,57)/t26-,33+,34+,35-,36+,37+,38+,39+/m1/s1

Notes unverified prose

FDA-approved (Imcivree); TRANSCEND trial; DailyMed

Not on file 0

All 8 tracked fields hold a value on this record: molecular weight and formula, CAS number, PubChem CID, amino-acid sequence, SMILES, InChI and InChI key.

Counted from the record itself, not from what a source said it was missing. 136 of 185 records still have at least one empty.