Research Reference
Setmelanotide
FDA-approved MC4 receptor agonist for rare genetic obesity
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Setmelanotide (Imcivree) is an FDA-approved MC4 receptor agonist for rare genetic forms of obesity caused by specific melanocortin pathway deficiencies.
Dosing Reference
Reconstitution
Add 5 mL bacteriostatic water to the 10 mg vial. Resulting concentration: 2 mg/mL.
| Dose | Syringe Units | mL Volume | Schedule |
|---|---|---|---|
| 0.5 mg | 25 units | 0.25 mL | SubQ, once dailyAdult starting dose (FDA) |
| 1 mg | 50 units | 0.5 mL | SubQ, once dailyAdult maintenance (FDA) |
| 3 mg | 150 units | 1.5 mL | SubQ, once dailyAdult max (FDA) |
| 0.2 mg | 10 units | 0.1 mL | SubQ, once dailyPediatric starting (FDA) |
Math assumes U-100 insulin syringes (1 mL = 100 units). Verify your syringe matches before use. Round half-units to the nearest visible mark.
Reconstitution
Setmelanotide (Imcivree) is FDA-approved for specific rare genetic obesity syndromes (POMC/LEPR/PCSK1 deficiency, Bardet-Biedl/Alström). It is supplied as a pre-filled syringe or vial at a fixed concentration. Compounded research-peptide forms are not FDA-approved.
For a compounded 10 mg vial reconstituted with 5 mL, the concentration is 2 mg/mL; a 1 mg dose draws to 50 units (0.5 mL) on a U-100 syringe. Store per manufacturer directions; compounded forms are not FDA-approved.
Cycling Protocol
FDA-approved setmelanotide is titrated from 0.5 mg daily to 1 mg daily (max 3 mg) as tolerated, used as chronic daily therapy for the indicated genetic obesity syndromes. No fixed cycle end; used long-term.
Routes of Administration
Subcutaneous injection (only established route): Once daily into the abdomen, thigh, or upper arm, independent of meals.
No oral, intranasal, or intravenous route is established. Compounded forms are not FDA-approved.
Stacking Protocols
| Stack | Components | Purpose | | --- | --- | --- | | MC4R + Lifestyle | Setmelanotide + diet/exercise | FDA-approved genetic-obesity protocol |
Setmelanotide is FDA-approved only for specific rare genetic obesity syndromes. Compounded forms are not FDA-approved.
Side Effects & Safety
- Skin hyperpigmentation — hallmark effect (MC1R agonism); reversible
- Injection-site reactions — common
- Nausea, vomiting, diarrhea — common
- Spontaneous penile erection — reported; may require dose reduction
- Transient darkening of nevi/freckles — common
Setmelanotide (Imcivree) is FDA-approved for specific rare genetic obesity syndromes. Compounded research-peptide forms are not FDA-approved.
Research Basis
Setmelanotide is a melanocortin-4 receptor (MC4R) agonist, FDA-approved (Imcivree).
Mechanism: Agonizes the MC4 receptor in the hypothalamic leptin-melanocortin pathway, restoring satiety signaling disrupted in specific genetic obesity syndromes (POMC, LEPR, PCSK1 deficiency; Bardet-Biedl/Alström syndromes).
Clinical evidence: FDA-approved for rare genetic obesity characterized by MC4 pathway deficiency. Demonstrated significant weight loss in these specific populations; not indicated for general obesity.
FDA-approved for specific rare genetic obesity syndromes only. Compounded research-peptide forms are not FDA-approved.