Melanotan II: what the studies show

A distinct molecule

Melanotan II is a cyclic melanocortin peptide, also called MT-II. It is distinct from afamelanotide, the drug in Scenesse, and from bremelanotide, the drug in Vyleesi. Those approvals do not extend to melanotan II. FDA has no approved melanotan II product.

The small human trials

A 1996 placebo-controlled pilot gave subcutaneous melanotan II to three healthy men during a two-week experiment. Two developed increased pigmentation. Nausea, fatigue, and spontaneous erections also occurred. A later crossover trial in ten men with organic erectile-dysfunction risk factors measured erections during monitored sessions. Erectile responses increased compared with placebo, but some injections caused severe nausea.

These experiments tested small groups of men and specific injected research material. They do not validate nasal sprays, online tanning products, or a repeat-use schedule.

Long-term tanning safety

Pigmentation is not evidence that a product prevents ultraviolet injury or skin cancer. Long-term benefit and safety for routine tanning remain unestablished. FDA's current compounding page places melanotan II among withdrawn nominations and retains safety concerns. Withdrawing a nomination does not establish approval or a validated protocol.