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 expected before end of 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 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: Moved on paper - nominated, removed from a restricted list, or recommended by an FDA committee - but not added to the 503A list. The headline implies a change; the legal status has not moved.

Verified Sep 22, 2026 (ET) · status held since Apr 22, 2026

Primary source: FDA All 8 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 dateSecond PCAC meeting on peptides, incl. Melanotan II - expected before end of Feb 2027, no date published - Feb 28, 2027 (in 140 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 expected before end of 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.
United Kingdom (MHRA)RestrictedNo UK marketing authorisation; MHRA has repeatedly removed melanotan products from sale for over 10 years, though nasal sprays without medicinal claims are not generally regulated as medicines.
European Union (EMA)RestrictedNo EU marketing authorisation - no melanotan II entry in EMA’s centrally authorised medicines database; sale as a medicine is unlawful EU-wide, with enforcement handled at member-state level.
Canada (Health Canada)RestrictedNot authorized for sale; Health Canada names Melanotan I and II among unauthorized injectable peptide drugs it has seized, warning that unauthorized drug products are illegal in Canada.
Sport / anti-doping (WADA)RestrictedProhibited at all times, but not listed by name - captured by the S0 catch-all for non-approved substances (also argued under S2).

The U.S. status is watched by automation every six hours. Statuses elsewhere change less often and are covered by a monthly wide-net sweep, then re-verified whenever a lead surfaces - this entry’s last-verified date covers every row above. How we track it

Sources & transparency

Sources for this entry

Last verified by a human
Sep 22, 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.

This page reports publicly available regulatory status for information only. It is not medical or legal advice and makes no health claim. See our full disclaimer.