Last updated October 21, 2026. Approval line checked October 21, 2026. Compounding sources checked October 10, 2026.
FDA status
Not approved
Not approved. This record is not an FDA-approved drug product. Approval, where it exists, is specific to a drug product, indication, and route.
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Evidence tier
Human Observational. The tier is the highest indexed study type. It is not a safety rating and it is not an FDA approval. Confidence score 2/5. 185 PubMed citations indexed.
Products sold as "research use only" are not approved for human use. FDA warning.
Cyclic analog of alpha-MSH acting as non-selective melanocortin receptor agonist (MC1R–MC5R) producing skin tanning, sexual arousal, and appetite suppression.
What the literature studies
Tanning & Sexual Function
Evidence tier
Human Observational
Compounding record
Nomination withdrawn
Nomination withdrawn. FDA substance context: Melanotan II. Previously in Category 2; FDA still identifies potential significant safety risks. Withdrawal is not FDA approval or a determination of safety or compounding eligibility. Research information is not evidence of FDA approval. Approval, where applicable, is specific to a drug product, indication and route.
Regulatory source checked October 10, 2026. This compounding label is separate from the approval line above.
serious adverse events including melanoma, posterior reversible encephalopathy syndrome, and priapism reported.
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Melanotan II is an unapproved melanocortin peptide sold illegally for tanning; FDA has warned against it for decades, lists serious adverse events including melanoma and priapism in compounding-risk documents, and a related seller was later debarred after felony convictions tied to unapproved sales.
A cyclic alpha-MSH analog (melanotan II) that stimulates melanocortin receptors; historically studied for pigmentation and sexual function, and widely diverted into unregulated tanning injectables [R1][FDA-RISK].
Not FDA-approved for any use. FDA warned Melanocorp in 2007 that marketing Melanotan II as a tanning/skin-cancer-prevention injectable violated the FDCA as an unapproved new drug [R2]. FDA later pursued debarment of the firm's owner after felony convictions related to continuing unapproved Melanotan II sales [R3]. FDA lists Melanotan II among nominated-but-withdrawn compounding substances, citing immunogenicity/impurity concerns and published case reports of melanoma, PRES, sympathomimetic toxidrome, and priapism [FDA-RISK]. Afamelanotide (Scenesse) is a different, FDA-approved MC1R agonist for erythropoietic protoporphyria - not Melanotan II.
Melanocortin pharmacology is established in animals; that does not make unapproved human tanning products safe or legal.
FDA-cited serious adverse events include melanoma, posterior reversible encephalopathy syndrome, sympathomimetic toxidrome, and priapism [FDA-RISK]. Common reported effects in literature/case series include nausea, flushing, appetite change, and pigmented lesion changes. Gray-market nasal sprays/injectables: composition unverified.
Continued enforcement against unapproved online peptide sales remains likely. Approved melanocortin drugs (e.g., Scenesse; Vyleesi/PT-141 for HSDD) are distinct products with their own labels.
Last checked 2026-10-27
Education only. Not medical advice. No dosing guidance. peptidex.ai does not sell peptides or link to sellers.