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No FDA-approved product

Melanotan II

Also called MT-II, MT-2, Melanotan 2.

Melanotan II has no FDA-approved product. This page cites 2 sources, and the strongest evidence comes from human trials.

Status
No FDA-approved product
Form
Injection
Half-life
Not modeled
Strongest evidence
Human trials
Cited claims
2
Last updated
November 6, 2026

What the evidence says

Each claim names the kind of study behind it, what it can't tell you, and where it comes from.

  1. Human trials

    A placebo-controlled phase 1 pilot in three healthy men found increased pigmentation in two participants after subcutaneous melanotan II; nausea, fatigue, and spontaneous erections were also reported.

    Limits: This very small, short experiment assessed pigmentation and acute effects. It could not establish long-term safety, reliable protection from ultraviolet injury, skin-cancer prevention, or a validated routine tanning schedule.

  2. Human trials

    A double-blind crossover study in ten men with organic erectile-dysfunction risk factors found more erectile responses and greater reported desire after subcutaneous melanotan II than after placebo.

    Limits: The study measured short-term responses during monitored sessions. Its small sample and frequent nausea, including severe episodes, leave long-term effectiveness and tolerability unresolved. The results do not establish FDA approval.

Regulatory status

United States

Melanotan II has no FDA-approved product. FDA has identified it as an unapproved new drug. Its small human experiments do not establish an approved tanning or erectile-dysfunction treatment. Afamelanotide and bremelanotide are separate molecules whose product approvals do not extend to melanotan II.