Melanocortin Receptor Agonist

Setmelanotide (Imcivree)

FDA-approved product existsWeight & metabolic
Not yet scored

BioHarmony verdict

Awaiting review

No BioHarmony report yet. It is queued for review; until then, rely on the status and sources below.

What is Setmelanotide (Imcivree)?

FDA-approved setmelanotide is marketed as Imcivree for chronic weight management in patients with obesity caused by specific rare genetic conditions covered by the label.

Dosing as published

Approved labelIMCIVREE prescribing information for labeled genetic and syndromic obesity indications
PopulationAdults and pediatric patients covered by the approved IMCIVREE indications
DoseStarting and titration doses depend on age, indication, weight, tolerability, and kidney function. For adults and patients 12 years and older with BBS or POMC, PCSK1, or LEPR deficiency, the label starts at 2 mg once daily for 2 weeks and lists 3 mg once daily as maintenance if tolerated.
RouteSubcutaneous injection in the abdomen, thigh, or arm
FrequencyOnce daily at the beginning of the day
DurationLong-term use within the approved indication, with label-defined response assessment
PreparationReady-to-use 10 mg/mL solution in a 1 mL multiple-dose vial; no reconstitution.
Source: Dosage and Administration sections 2.1-2.6; Dosage Forms and Strengths section 3

More reported protocols

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Members can compare additional reported doses, schedules, and preparation notes.

Trust & sourcing

US approvalFDA-approved product exists
CompoundingFDA-approved product exists; compounded copies are not FDA approved
Last checked2026-07-13
Next review2026-10-11

Primary sources

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