U.S. Food and Drug Administration (FDA)
Is Melanotan II legal in United States?
Not approvedNo FDA approval; FDA cites reports of melanoma and other serious events, and its advisers will consider it before the end of February 2027
Not approved as a medicine here.
Melanotan II is not approved for any use. FDA's Category 2 page lists it among withdrawn nominations and cites published case reports of serious adverse events including melanoma, posterior reversible encephalopathy syndrome, sympathomimetic toxidrome and priapism. According to a law-firm report, FDA has said the Pharmacy Compounding Advisory Committee will consider Melanotan II before the end of February 2027; until FDA acts it is not on the 503A bulks list.
Last verified 2026-09-29 · how we verify
Melanotan II elsewhere
Sources (3)
- 01Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (Category 2 and withdrawn nominations)U.S. Food and Drug Administration · 2026-04-22 · accessed 2026-09-29
- 02Bulk list bound? PCAC backs majority of peptides in two-day public meetingMcDermott Will & Schulte · 2026-07-27 · accessed 2026-09-29
- 03Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C ActU.S. Food and Drug Administration · 2026-05-14 · accessed 2026-09-29