Melanotan II

MT-2

Grade C: Preliminary or limited human evidence

TL;DR: Melanotan II is a synthetic cyclic melanocortin peptide sold on the gray market as an injectable tanning and libido agent. The only randomized controlled human trial is a small double-blind, placebo-controlled crossover study in 20 men (PMID 11035391) that measured penile erection and sexual desire, not tanning. The cosmetic tanning use people seek it for rests only on a 1996 phase I pharmacology study in 3 volunteers (PMID 8637402), not on any efficacy trial. It is not FDA-approved and has no legal US pharmaceutical pathway, and the published human record is dominated by harm reports rather than efficacy data.

Key Takeaways

Grade C: Preliminary or limited human evidence
Not FDA approved: Not FDA-approved; never approved for any indication. Distinct from afamelanotide (Scenesse), a different melanocortin drug the FDA approved in 2019 for erythropoietic protoporphyria.
Compounding: Not FDA-approved and never approved; it is an unapproved new drug sold through unregulated online and gray-market channels, with no legal pharmaceutical compounding pathway in the US.

Melanotan II chemical structure — Structure via PubChem CID 92432

Mechanism

Non-selective melanocortin receptor agonist (MC1R, MC3R, MC4R, MC5R). MC1R activation drives skin pigmentation; MC3R and MC4R activity produce the sexual and appetite effects.

Evidence

Melanotan II is a synthetic cyclic melanocortin peptide sold on the gray market as an injectable tanning and libido agent. The only randomized controlled human trial is a small double-blind, placebo-controlled crossover study in 20 men (PMID 11035391) that measured penile erection and sexual desire, not tanning. The cosmetic tanning use people seek it for rests only on a 1996 phase I pharmacology study in 3 volunteers (PMID 8637402), not on any efficacy trial. It is not FDA-approved and has no legal US pharmaceutical pathway, and the published human record is dominated by harm reports rather than efficacy data.

Safety and risks

Published human case reports document serious harms following Melanotan II use, including malignant melanoma and changes in existing moles (PMID 24355990), an oral mucosal melanoma after nasal-spray use (PMID 40210573), rhabdomyolysis with systemic toxicity requiring intensive care (PMID 23121206), priapism (PMID 23537392), and renal infarction (PMID 31953620). These are individual case reports, so they show the harm can occur, not how often, and the melanoma cases often involved concurrent UV or sunbed exposure. Because the product is unregulated, purity and dose cannot be verified. Nausea, facial flushing, spontaneous yawning, and darkening of moles are commonly self-reported.

Interactions

Not formally characterized in humans. Cardiovascular and sympathomimetic effects have been reported, so caution is warranted with other agents that raise blood pressure or heart rate.

Federal compounding status

Nomination withdrawn (was Category 2) as of 2026-06-02.

This substance was nominated for the FDA 503A or 503B bulk-substances list and previously sat in the Category 2 (significant safety risk) group; the nomination was later withdrawn, so it is not on an active FDA bulks list and is not eligible for routine pharmacy compounding. FDA source

Federal status only, from public FDA records. State pharmacy-board rules vary and are not covered here. This is regulatory reporting, not legal advice. All compounds.

Compounding legality

Not FDA-approved and never approved; it is an unapproved new drug sold through unregulated online and gray-market channels, with no legal pharmaceutical compounding pathway in the US.

Sources

Melanotan II is Not FDA approved. PeptideGrids presents evidence and regulatory status for informational purposes only. We do not sell, supply, source, or help anyone obtain this compound, and we provide no dosing or administration guidance. This is not medical advice; consult a licensed clinician. Full disclaimer.

Last reviewed June 2, 2026 by PeptideGrids editorial team (independently audited).