U.S. regulatory status
Melanotan II
Also known as MT-II · MT-2 · Melanotan-2
Is Melanotan II legal right now?
Melanotan II is not FDA-approved for any indication and is not on the 503A Category 1 list of substances pharmacies may compound. It had been in Category 2 (significant safety risks); in April 2026 the FDA began moving a group of peptides out of Category 2 and scheduling advisory committee (PCAC) reviews, with Melanotan II among them. Removal from Category 2 does not by itself legalize compounding or place a substance on the 503A list, so it sits in a transitional status where compounding still carries regulatory risk. Melanotan II was not on the July 23-24, 2026 PCAC agenda; it is one of five substances - alongside LL-37, GHK-Cu, Dihexa acetate and PEG-MGF - expected at a second PCAC meeting the FDA has signalled for before the end of February 2027, though no date has been published. It is not a DEA-scheduled controlled substance, and the FDA-approved MC1R agonist afamelanotide is a separate compound.
In limbo: Nominated or removed from a restricted list but NOT approved - the headline implies a change, but the legal reality did not move.
Verified Aug 11, 2026 (ET) · status held since Apr 22, 2026
Where it sits in the process
- Nominated (passed)
- Under review (stalled here - not advancing)
- Rulemaking (not reached)
- Compounding-legal (not reached)
Not on a path to the 503A list right now. The process stalled or reversed at this stage - read the status above. Sitting at an earlier step is not a sign it will advance.
What changed last
Moved out of Category 2 and slated for a later PCAC review - the change did not legalize compounding.
Status elsewhere
| Jurisdiction | Status | Note |
|---|---|---|
| United States (FDA) | In limbo | Not on Category 1 / the 503A list; being moved out of Category 2; PCAC review expected before end of Feb 2027. Not DEA-scheduled. |
| Australia (TGA) | Restricted | Schedule 4 (prescription-only); no products registered on the ARTG; TGA has issued infringement notices for unlawful supply. |
| Sport / anti-doping (WADA) | Restricted | Prohibited at all times, but not listed by name - captured by the S0 catch-all for non-approved substances (also argued under S2). |
Sources & transparency
Sources for this entry
- FDA - 503A bulk drug substances: Category 1 & Category 2 lists FDA · primaryMelanotan II is not on the 503A Category 1 list; being moved out of Category 2 does not authorize compounding.
- FDA Law Blog - FDA's Pep(tide) Rally (Hyman, Phelps & McNamara) analysisMelanotan II among peptides slated for a PCAC review before end of February 2027.
- Orrick - FDA peptide compounding vote: what to watch at the July PCAC meeting analysisNames the five substances expected at the second PCAC meeting: LL-37, GHK-Cu, Dihexa acetate, Melanotan II, PEG-MGF.
- Boesen & Snow Law - FDA advances peptide compounding review analysisRemoval from Category 2 does not place a substance on the 503A list; cites Docket FDA-2025-N-6895.
- The Conversation - Melanotan and Australian scheduling (secondary) analysisSecondary source noting Melanotan is Schedule 4 with no ARTG-registered products in Australia; confirm against the TGA Poisons Standard.
- Last verified by a human
- Aug 11, 2026 (ET) · how we verify
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