Melanotan II regulatory status
Current status of Melanotan II in the United States: Removed from Category 2 (Apr 2026). In sport: WADA prohibited. Details, sources, and the dated timeline follow.
By the PeptideAgent Editorial Team. Draft, pending editorial review. Last verified
What is the current status of Melanotan II?
- FDA and compounding
- Melanotan II was placed on the FDA 503A Category 2 list (substances that may present significant safety risks) with FDA citing immunogenicity risk, peptide impurities, and published case reports of melanoma, posterior reversible encephalopathy syndrome, sympathomimetic toxidrome, and priapism. As of the FDA page current to April 22, 2026, its nomination has been withdrawn, so it no longer sits in Category 2, but it is not on the 503A bulks list, was not among the peptides the Pharmacy Compounding Advisory Committee took up in July 2026, and is not a component of any approved drug. A 503A pharmacy therefore has no basis to compound it. It is not approved as a drug in any country.
- WADA
- WADA prohibited
- Access path
- Not legally available for human use in the United States.
- Not an FDA approved drug and not compoundable under 503A or 503B.
- Products sold online as tanning injections or nasal sprays are not lawful for human use and are not verified for purity.
Full Melanotan II page: evidence, dosing in the literature, and sources
Is Melanotan II FDA approved or legal? Questions and answers
Is Melanotan II FDA approved?
No. Melanotan II is not approved as a drug in the United States or any other country. The related peptide afamelanotide is FDA approved only as the Scenesse implant for erythropoietic protoporphyria, which is a different molecule and not a tanning product. [1] [2]
What is the FDA status of Melanotan II in 2026?
Removed from Category 2, with no path forward. FDA placed Melanotan II on the 503A Category 2 list, citing immunogenicity, impurities, and case reports of melanoma, posterior reversible encephalopathy syndrome, and priapism. Its nomination has since been withdrawn, but it is not on the 503A bulks list and was not taken to the July 2026 advisory committee, so a 503A pharmacy has no basis to compound it. [1] [3]
Is Melanotan II legal?
There is no lawful route to obtain Melanotan II for human use in the United States. It is not an approved drug and cannot be compounded under 503A or 503B. Products sold online as tanning injections or nasal sprays are not lawful for human use and are not verified for purity. [1] [3]
Is Melanotan II banned by WADA?
Yes. Melanotan II has no approval from any government health authority, which places it in section S0 (non-approved substances) of the WADA Prohibited List. It is prohibited at all times. [4]
How has the status of Melanotan II changed over time?
- FDA
FDA lists BPC-157 and 16 other peptides as withdrawn from 503A Category 2
FDA's Category 2 page, revised in April 2026 and current as of April 22, 2026, moved BPC-157, AOD-9604, CJC-1295, dihexa, DSIP, epitalon, injectable GHK-Cu, ipamorelin, KPV, LL-37, melanotan II, MOTS-c, PEG-MGF, selank, semax, thymosin alpha-1, and thymosin beta-4 fragment (TB-500) to a list of bulk drug substances nominated but withdrawn by their nominators. A withdrawn substance is no longer in 503A Category 2, but withdrawal is not an approval and does not place a substance on the 503A bulks list; a 503A pharmacy still needs a listing before it may compound it. Ipamorelin acetate remains in 503B Category 2. Seven of the withdrawn peptides (BPC-157, KPV, TB-500, MOTS-c, semax, epitalon, and DSIP) were taken to the Pharmacy Compounding Advisory Committee in July 2026.
- FDA
FDA places a batch of nominated peptides in 503A Category 2
In September 2023 FDA updated its 503A bulk drug substances category lists to place a group of nominated peptides in Category 2, which means FDA identified significant safety risks and the substances may not be used in 503A compounding while the evaluation continues. Kisspeptin-10 and ibutamoren (MK-677) were added on September 29, 2023 and remain in Category 2 on the FDA page current as of April 22, 2026. BPC-157, CJC-1295, ipamorelin, AOD-9604, dihexa, DSIP, epitalon, KPV, MOTS-c, selank, semax, melanotan II, LL-37, thymosin alpha-1, and thymosin beta-4 fragment (TB-500) were also placed in Category 2 under the 503A interim policy; that same page now lists them as nominated but withdrawn (see the April 2026 event). Hexarelin, PNC-27, and 5-amino-1MQ have never appeared on the FDA category lists.
Sources
Numbered citations in the answers above point here, followed by the regulatory sources on record for Melanotan II and the source of each dated event.
- [1]FDA: Certain bulk drug substances for use in compounding that may present significant safety risks (Category 2 list and withdrawn nominations, current as of April 22, 2026)FDA, 2026
- [2]FDA prescribing information for Scenesse (afamelanotide) implant, via DailyMedFDA, 2025
- [3]FDA: Compounding and the FDA, questions and answersFDA, 2026
- [4]WADA Prohibited List, section S0 non-approved substancesWADA, 2026
From the blog
- Melanotan 2 before and after: what trials and case reports show
Melanotan 2 before and after photos show a tan. Early trials measured it in a few men; case reports since document new moles, melanoma, priapism and FDA safety concerns.