Melanotan II

What it is

Melanotan II (MT-II) is a synthetic non-selective melanocortin-receptor agonist, marketed for skin tanning.S1

Marketed as

Melanotan II is marketed as a "tanning" peptide (the "Barbie drug") for a sunless tan, and sometimes falsely as sun or skin-cancer protection. These are marketing claims for an unapproved, illegally sold product — and the safety record below is the dominant fact.S2

Regulatory status (US)

MT-II is not FDA-approved and has not received regulatory approval in any jurisdiction.S1S2 On FDA's compounding framework, Melanotan II appears in the "nominated but withdrawn" portion of Category 2.S1 FDA has issued consumer warnings about unapproved tanning products of this type.S2

Around the world

Melanotan II is unapproved essentially everywhere. The UK banned its sale and supply, and health authorities warn against it.S3 Australia's TGA and EU regulators likewise treat it as an unapproved product rather than a licensed medicine.S1S2 It's the same illegal gray-market product across borders.

Safety

Safety is the dominant fact about MT-II. Published case reports associate its use with melanoma / accelerated atypical nevus change, ischemic priapism, rhabdomyolysis, renal infarction, and posterior reversible encephalopathy syndrome (PRES), along with cardiovascular effects (hypertension, tachycardia) and severe nausea/vomiting.S2

Evidence

There are no completed Phase 3 trials establishing a safe, effective dose range in humans; the therapeutic evidence base is essentially absent.S2

Anti-doping

MT-II is a melanocortin agonist, not a peptide hormone or growth factor; its WADA status is not clearly that of a named prohibited substance. This should be confirmed directly before it is stated without qualification.

What's changing

The reported PCAC review is the near-term regulatory item, but the safety record above is the through-line regardless of compounding status.S2