Melanotan II

Overview

Synthetic peptide that stimulates melanogenesis, causing skin darkening. Also affects libido.

Reported benefits

Skin tanning without UV exposure, increased libido, potential appetite suppression

Protocols & dosing

Typical dosage: 250-500 mcg (as needed).

Detailed dosing protocols have not yet been catalogued.

FDA & legal status

Melanotan II is not currently FDA-approved for any indication. Effective April 22, 2026, the FDA removed Melanotan II from Category 2 of its Section 503A bulk drug substances list after the original nominators withdrew their nominations. This removal lifts the prior “significant safety risk” designation but does not place Melanotan II on the 503A Bulks List. Compounding pharmacies may prepare it with a valid physician prescription and pharmaceutical-grade API from an FDA-registered manufacturer. The FDA’s Pharmacy Compounding Advisory Committee (PCAC) is scheduled to review this substance at its July 23–24, 2026 public meeting. Removed from FDA Category 2 effective April 22, 2026. NOT selected for July 23-24, 2026 PCAC meeting. Deferred to second PCAC meeting before February 2027. NOT currently on 503A Bulks List — requires physician Rx. Source: FDA Advisory Committee Calendar / Lengea Law, May 2026.

Vendor information

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Side effects & safety

Reported side effects: Nausea, facial flushing, darkening of moles, potential cardiovascular effects

References

No external sources have been catalogued for this article yet.