Melanotan II

No approved product in any jurisdiction reviewed. No approved product is identified in the United States.

Prohibited. Melanotan II is not named on the Prohibited List. It falls within class S0, non-approved substances, prohibited at all times, because it holds no approval from any governmental regulatory health authority for human therapeutic use. The S0 wording is as reproduced from the List rather than rendered from WADA's own PDF, and no anti-doping authority page located names melanotan explicitly. This status is not personal clearance to compete.

Two small human studies exist. A three-person 1996 phase 1 pilot reported increased pigmentation of the face, upper body and buttocks in two of three subjects, along with nausea, somnolence and spontaneous erections lasting one to five hours. A twenty-man randomised crossover study in 2000 reported erections without sexual stimulation in seventeen of twenty men and increased sexual desire after 68 per cent of melanotan II doses versus 19 per cent of placebo doses, with severe nausea in 12.9 per cent of subjects at the higher dose level. The published harm record includes rhabdomyolysis with a creatine kinase of 17,773 IU/L and three days of intensive care after a single 6 mg self-injection of mass-spectrometry-confirmed melanotan II, renal infarction affecting roughly half of one kidney after 27 mg subcutaneously over six months, acute ischaemic priapism after subcutaneous use that failed phenylephrine and irrigation and required penoscrotal decompression, melanoma reported alongside melanotan II use, oral mucosal melanoma after nasal-spray use, and a dermatology review documenting melanocytic change in existing moles, new dysplastic naevi, and four case reports of melanoma emerging from existing moles during or shortly after melanotan use.

There is no phase 2 or phase 3 trial for any use, no long-term safety data, no established human dose or interval, no human pharmacokinetic profile, no data at all on nasal-spray absorption despite that being a common consumer route, and no comparison against afamelanotide. Whether melanotan II causes melanoma is unresolved: the reports are individual cases, several confounded by sunbed or ultraviolet exposure, with no cohort or registry study. Because no market authorisation exists, no post-marketing surveillance system exists either, so the frequency of any serious harm is unknown rather than known to be low.

Supported with scope. A three-person 1996 phase 1 pilot measured increased pigmentation in two of three subjects using a defined subcutaneous dose of characterised drug. That is a real pharmacological signal and nothing more: it does not establish magnitude, durability, reproducibility at consumer doses, nasal-spray dosing, or safety. Scope: Pigmentation as a measured effect in a three-person 1996 pilot study using characterised drug; not consumer products, nasal sprays, or any claim about how much tan, for how long, or at what risk.

Misleading. No trial of any kind has tested sunburn, ultraviolet damage, or skin cancer as an endpoint. The published record runs the other way: melanoma and dysplastic naevus case reports, a review counting four melanomas emerging from existing moles during or shortly after melanotan use, and an approved melanocortin-1 agonist whose label calls for twice-yearly full-body skin examination because it can darken pre-existing naevi. Scope: All protective or preventive framing, including the comparison with sunbeds.

Misleading. Scenesse is a clinician-placed controlled-release implant of afamelanotide, a different molecule that binds predominantly to the melanocortin-1 receptor, approved for photosensitivity in erythropoietic protoporphyria. Vyleesi is bremelanotide, approved for a defined sexual-desire disorder in certain premenopausal women. Melanotan II is neither molecule and has no approval, no label, no established dose, and no verified vial content. Scope: Both versions of the confusion: melanotan marketed as equivalent to the approved Scenesse implant, and melanotan II marketed as a cheaper route to the approved bremelanotide effect.

Misleading. Research-use-only wording is a marketing label, not a legal status for human use. Selling and supplying melanotan injections is illegal in the UK. Australia's regulator treats melanotan II as a prescription-only medicine that is unapproved, and issued one supplier 27 infringement notices totalling AU$101,412. That same research-chemical channel is the one whose products were found to contain roughly 43 to 88 per cent of the labelled amount plus unidentified impurities. Scope: The legality of sale and supply, which is where enforcement in these jurisdictions is directed; it says nothing about what happens to an individual purchaser.

Not established. Nausea is the dominant effect in the trial record, severe in 12.9 per cent of subjects at the higher dose in the 2000 study. But the published case literature also contains rhabdomyolysis and renal impairment requiring intensive care, renal infarction affecting roughly half a kidney, and acute ischaemic priapism that failed drug and irrigation treatment and required surgical decompression, a time-critical emergency carrying permanent erectile-dysfunction risk. These are case reports: they prove occurrence, not frequency. The honest statement is that the frequency of serious harm is unknown because no surveillance system exists, not that serious harm is rare. Scope: The completeness of the adverse-effect picture. Case reports establish that these events happened after use with temporal association; they cannot establish incidence or causation.