Melanotan II: Evidence and FDA Status

Regulatory record

Melanotan II is one of five bulk drug substances scheduled for a second Pharmacy Compounding Advisory Committee meeting before the end of February 2027, with Dihexa acetate, LL-37, GHK-Cu, and PEG-MGF. The April 2026 FDA action that set the July 2026 meeting set this later meeting too. As of 1 June 2026 there was still no public docket and no primary Federal Register agenda for February. Federal Register notice 2026-07361 is the July record, and Melanotan II is not on it. That notice names BPC-157, KPV, TB-500, and MOTs-C for July 23, and Emideltide (DSIP), Semax, and Epitalon for July 24. The February names are secondary coverage of the April announcement, not text from the July notice.

Melanotan II is not PT-141. PT-141 is bremelanotide, a related molecule with its own approval history as Vyleesi, and it is not on the July 2026 or February 2027 meetings. The PT-141 reference is the page for that molecule. Treating a Melanotan II study, or a PT-141 study, as evidence for the other one is a different claim, and this page does not make it.

The docket record also does not give Melanotan II a Category 1 or Category 2 move. Category 2 is the do-not-compound list. Category 1 is the under-evaluation list, where compounding had been temporarily allowed under enforcement discretion. Dihexa acetate is the February substance the record says left Category 2. Melanotan II is only listed as scheduled. PCAC recommends. FDA decides later by rulemaking. A February slot is not an approval and not a reviewed use. The July chart of uses does not cover this compound. Both meetings are set out in the July 2026 PCAC review.

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