Home | Regulatory Tracker | Melanotan II
Melanotan II
Nomination withdrawn
as of October 2026
By Stephen Kimball, 26+ years researching the health, wellness, supplement, and peptide industries
As of October 2026, Melanotan II isn’t approved for any use and isn’t on any list that would let pharmacies compound it. It left FDA’s safety-risk list in April 2026 because its nominators withdrew, but FDA still lists published case reports of serious problems, including melanoma, a brain-swelling syndrome called PRES, and priapism. A law firm tracking the issue reports it will go before FDA’s advisory panel before the end of February 2027; FDA hasn’t confirmed that for Melanotan II. It’s sold mainly as “research use only” tanning injections and nasal sprays. Note that bremelanotide (PT-141), which is approved as Vyleesi, is a different compound.
Sources
Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (withdrawn table)
U.S. Food & Drug Administration
dated Apr 2026
Bulk Drug Substances Nominated for Use in Compounding Under Section 503A (categories list — Melanotan II absent from Category 1)
U.S. Food & Drug Administration
dated May 2026
Change log
2023
FDA places Melanotan II in Category 2.
April 2026
Moves to the “nominated but withdrawn” table; FDA’s safety note stays listed.
July 27, 2026
McDermott reports Melanotan II will be considered at a PCAC meeting before end of February 2027.