● TIER 1 — FDA-approved / recognizedGRADE AMelanocortins
Setmelanotide
MC4R agonist. Research verification: Yes (TGA pending). 1 human study record(s) in the FitClinicMD studies database.
GOALS · Weight loss
FDA status
Approved: Imcivree.
Compounding (503A/503B)
Approved.
DEA
Not controlled.
WADA (sport)
Not listed on 2026 Prohibited List (no matching section found)
Mechanism
MC4R agonist.
Human evidence · 1
Two phase 3 trials (POMC n=10, LEPR n=11). Efficacy and safety of setmelanotide, an MC4R agonist, in individuals with severe obesity due to LEPR or POMC deficiency: single-arm, open-label, multicentre, phase 3 trials.
Reference only. This page summarizes publicly available regulatory and research information about Setmelanotide. It is not a prescription, an endorsement, or an offer to dispense, and regulatory status can change. Clinicians should verify current status before prescribing or compounding.