Melanotan II: Regulatory Status
Current legal and regulatory status for Melanotan II across jurisdictions. This page reflects the most recent verified information and is updated as regulatory actions occur.
Back to Melanotan II overviewUnited States
Research Only
Compounding status: Category 2 (restricted) — remains restricted per Feb 2026 HHS announcement. WADA: prohibited (S2 — peptide hormones). Banned for sale in Australia (TGA), UK (MHRA warnings), EU (multiple national agency warnings). Widely available through underground/grey market. Multiple deaths and hospitalizations reported to poison control centers worldwide.
What This Means
Reclassification is not the same as FDA approval.
Even if Melanotan II moves to Category 1, it remains an off-label therapeutic that requires physician supervision. Category 1 means it can be compounded under section 503A — it does not confer approved-drug status.