● TIER 1 — FDA-approved / recognizedGRADE A (afamelanotide) / D (MT-II)Melanocortins
Afamelanotide (MT-I) / Melanotan II
Melanocortin agonists. Research verification: Yes (TGA pending). 2 human study record(s) in the FitClinicMD studies database.
GOALS · Skin · Sexual function
FDA status
Afamelanotide: Scenesse implant approved (EPP). MT-II: unapproved.
Compounding (503A/503B)
MT-II: nominated-but-withdrawn; FDA cites melanoma, PRES, priapism case reports
DEA
Not controlled.
WADA (sport)
Not listed on 2026 Prohibited List (no matching section found)
Mechanism
MC1R (pigment), MC3/4R.
Human evidence · 2
Afamelanotide EPP: two RCTs (n=94 US, n=74 EU). Afamelanotide for Erythropoietic Protoporphyria.
Case report: melanoma associated with MT-II. Melanoma associated with the use of melanotan-II.
Reference only. This page summarizes publicly available regulatory and research information about Afamelanotide (MT-I) / Melanotan II. 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.