Peptide LibrarySetmelanotide dosage in published studies and labels
These are the doses used for Setmelanotide in FDA labelling and published clinical studies, reported as each source states them, one row per regimen. They describe what was studied or approved for a specific population. They are not a recommendation, and none of them is a dose for any individual.
Research and educational reference only. This is not medical advice, and no figure on this page is a dosing recommendation.
Last checked against primary sources:
Studied regimens and sources
Setmelanotide has an FDA-approved human dosage. As Imcivree it is titrated to a maintenance dose of 3 mg subcutaneously once daily in patients aged 6 and over, starting at 0.5 mg or 2 mg depending on indication and age, with weight-based dosing for children aged 2 to 6. Every approved use is a rare genetic or acquired melanocortin-pathway obesity, not general weight loss.
| Human dosing established | Yes |
|---|---|
| Studied dose range | 0.5–3 mg once daily, titrated |
| Route | Subcutaneous |
| Frequency | Once daily |
| Duration studied | Continuous |
| Titration | Stepwise over 2–8 weeks by tolerance and age group, with specific protocols for managing gastrointestinal effects. Starting dose is 0.5 mg for acquired hypothalamic obesity aged 4+, or 2 mg for patients aged 12+ with Bardet-Biedl syndrome or POMC/PCSK1/LEPR deficiency. |
| Evidence level | FDA Approved |
| Last reviewed | 2026-09-05 |
Research-reported dosing
Doses as studied, one row per regimen. Different trials used different regimens; they are listed separately rather than averaged.
| Study / context | Population | Dose | Route | Frequency | Duration | Outcome studied | Source |
|---|---|---|---|---|---|---|---|
| FDA label — ImcivreeFDA-approved label · FDA prescribing information | Patients aged 4+ with acquired hypothalamic obesity; aged 2+ with Bardet-Biedl syndrome; aged 2+ with confirmed POMC, PCSK1 or LEPR variants | 3 mg maintenance for ages 6+; weight-based for ages 2–6 | Subcutaneous | Once daily | Continuous | Reduction of excess body weight | IMCIVREE (setmelanotide) injection — FDA prescribing information, DailyMed |
| Phase 3 — acquired hypothalamic obesity (2026)Clinical trial · Phase 3 randomised trial | Patients with acquired hypothalamic obesity | Per trial protocol, titrated | Subcutaneous | Once daily | Per trial protocol | Body mass index reduction | Setmelanotide for the Treatment of Acquired Hypothalamic Obesity. N Engl J Med. 2026. |
| NCT03746522 — phase 3, Bardet-Biedl syndrome, results postedClinical trial · Phase 3 trial with posted results | Patients with Bardet-Biedl syndrome (n=52) | Per trial protocol | Subcutaneous | Once daily | — | Weight and hunger scores | NCT03746522 — Setmelanotide (RM-493), MC4R Agonist, in Bardet-Biedl Syndrome |
| NCT03287960 — phase 3, LEPR deficiency, results postedClinical trial · Phase 3 trial with posted results | Patients with leptin receptor deficiency obesity (n=15) | Per trial protocol | Subcutaneous | Once daily | — | Weight reduction | NCT03287960 — Setmelanotide for the Treatment of Leptin Receptor (LEPR) Deficiency Obesity |
Where sources disagree
- The approved dose is indication- and age-specific, and the starting dose differs fourfold between indications (0.5 mg versus 2 mg). A single "setmelanotide dose" figure is not meaningful without naming the population.
- Every approved indication is a rare melanocortin-pathway disorder — Bardet-Biedl syndrome, POMC/PCSK1/LEPR deficiency, acquired hypothalamic obesity. Setmelanotide is not approved for common obesity, and the trial populations were small and genetically defined.
- Setmelanotide is a melanocortin-4 receptor agonist, mechanistically related to melanotan II and bremelanotide but with a different receptor selectivity profile. Dosing does not transfer between them.