melanocortin-4 receptor agonist
Setmelanotide dose
Answer
FDA label for Imcivree: The recommended starting dosage is 0.5 mg (0.05 mL) injected subcutaneously once daily for 2 weeks. Trials with posted results tested 5 doses, most often 2 mg, 3 mg, 5 mg.
Not dosing advice.
FDA LABEL
What the approved labels state
Imcivree NDA213793 · label of 2026-04-01 Regulator
The recommended starting dosage is 0.5 mg (0.05 mL) injected subcutaneously once daily for 2 weeks.
IN TRIALS
Doses tested in 14 trials with posted results
| Dose in the arm title | Trials | People on it | Phases |
|---|---|---|---|
| 2 mg | 2 | 57 | 1/2/4 |
| 3 mg | 1 | 24 | 4 |
| 5 mg | 1 | 23 | 4 |
| 1.5 mg | 1 | 22 | 2 |
| 7 mg | 1 | 21 | 4 |
Trial register Read from the titles of arms that received Setmelanotide (n ≥ 20). An arm naming several doses counts under each; a schedule or escalation is on the trial record. All trials.
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