U.S. regulatory status

Melanotan II

Also known as MT-II · MT-2 · Melanotan-2

In limboOff Category 2, not on the 503A list; PCAC review before Feb 2027

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 slated for review by the end of February 2027. 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. 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 Jul 7, 2026 (ET) · status held since Apr 22, 2026

Primary source: FDA All 4 sources

Where it sits in the process

  1. Nominated
  2. Under review
  3. Rulemaking
  4. Compounding-legal

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.

Next scheduled dateFDA advisory committee (PCAC) review of Melanotan II (before end of Feb 2027) - Feb 28, 2027 (in 235 days)

What changed last

  1. Moved out of Category 2 and slated for a later PCAC review - the change did not legalize compounding.

    Not legalizedView on boesensnowlaw.com

Status elsewhere

JurisdictionStatusNote
United States (FDA)In limboNot on Category 1 / the 503A list; being moved out of Category 2; PCAC review before Feb 2027. Not DEA-scheduled.
Australia (TGA)RestrictedSchedule 4 (prescription-only); no products registered on the ARTG; TGA has issued infringement notices for unlawful supply.
Sport / anti-doping (WADA)RestrictedProhibited under S2 (peptide hormones).

Sources & transparency

Sources for this entry

Last verified by a human
Jul 7, 2026 (ET) · how we verify
Who runs this
Peptlas Research Team - independent. About us.
What we sell
Nothing. No products, no affiliates, no sponsored placements.
Confidence
medium - some facts here rest on secondary reporting. Always confirm against the primary source before you rely on it.

This page reports publicly available regulatory status for information only. It isnot medical or legal advice and makes no health claim. See ourfull disclaimer.