Melanotan II

Dorr RT et al., 1996, Life Sci, "Evaluation of melanotan-II, a superpotent cyclic melanotropic peptide in a pilot phase-I clinical study," 58(20): 1777-1784. PMID: 8637402; https://pubmed.ncbi.nlm.nih.gov/8637402/

Population: 3 healthy male volunteers

Dose protocol: SC 0.01 mg/kg starting, escalations to 0.025–0.03 mg/kg over 2 weeks

Key findings: Pigmentation increase documented. Mild nausea and dose-related somnolence/fatigue at higher doses.

Notes: Very small sample. Mechanistic proof-of-concept quality.

Wessells H et al., 1998, J Urol, "Synthetic melanotropic peptide initiates erections in men with psychogenic erectile dysfunction: double-blind, placebo controlled crossover study," 160(2): 389-393. PMID: 9679884; https://pubmed.ncbi.nlm.nih.gov/9679884/

Population: 10 men with psychogenic erectile dysfunction

Dose protocol: 0.025 mg/kg SC

Key findings: Strong short-window erectogenic signal versus placebo with manageable acute side effects in protocol context.

Notes: Not a broad wellness or tanning efficacy endpoint.

Nelson ME et al., 2012, Clin Toxicol (Phila), "Melanotan II injection resulting in systemic toxicity and rhabdomyolysis," 50(10): 1169-1173. PMID: 23121206; https://pubmed.ncbi.nlm.nih.gov/23121206/

Population: Adult self-administering injected melanotan II bought online

Dose protocol: 6 mg subcutaneous single administration

Key findings: Severe sympathomimetic toxicity with CPK/creatinine elevation and rhabdomyolysis.

Notes: Single high-dose off-label context. Highlights risk from misuse and quality uncertainty.

Mallory CW et al., 2021, Sexual Medicine, "Melanotan Tanning Injection: A Rare Cause of Priapism," 9(1): 100298. PMID: 33460908; https://pubmed.ncbi.nlm.nih.gov/33460908/

Population: Adult male with ischemic priapism after injection

Dose protocol: Post-injection case context

Key findings: Priapism can occur after melanotan II tanning injections and may require emergent urologic intervention.

Notes: Rare-event signal. Not suitable for incidence estimation.

Breindahl T et al., 2015, Drug Test Anal, "Identification and characterization by LC-UV-MS/MS of melanotan II skin-tanning products sold illegally on the Internet," 7(2): 164-172. PMID: 24771717; https://pubmed.ncbi.nlm.nih.gov/24771717/

Population: Illicitly distributed Melanotan II product samples

Dose protocol: N/A

Key findings: Impurity and dose-content discrepancies identified, including product labeling and measured-content mismatch.

Notes: Directly informs contamination/dose unpredictability risk in non-authorized supply chains.

Habbema LH et al., 2017, International Journal of Dermatology, "Risks of unregulated use of alpha-melanocyte-stimulating hormone analogues: a review," 56(10): 975-980. PMID: 28266027; https://pubmed.ncbi.nlm.nih.gov/28266027/

Population: Users of melanotan-like compounds

Dose protocol: N/A

Key findings: Unregulated use associated with melanocytic changes and melanoma case reports. Afamelanotide is a distinct approved analogue with a limited indication.

Notes: Causality for melanoma remains uncertain. Evidence quality for long-term safety is limited.

TGA public safety warning on melanotan products; unapproved status and health risks. https: //www.tga.gov.au/news/blog/dont-risk-using-tanning-products-containing-melanotan

Population: General public in regulated market

Dose protocol: N/A

Key findings: Melanotan products are illegal and can produce serious side effects including pigment and serious-cancer concerns. No lawful tanning approvals.

Notes: Policy source for access/safety classification.

HPRA warning: Melanotan 2 self-tan products not authorized medicine and associated with health risk messaging. https://www.hpra.ie/news-events/news/article/hpra-highlights-serious-health-risk-of--melanotan-2--self-tan-products

Population: Public consumers and regulators

Dose protocol: N/A

Key findings: Supports unauthorized-status context and absence of approved safety evidence for tanning use.

Notes: Secondary confirmation of regulatory pattern from independent agencies.

Health Canada public advisory: unauthorized injectable peptide drugs, including melanotan compounds, identified as unauthorized and potentially unsafe. https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious

Population: Consumers of unauthorized injectable peptides

Dose protocol: N/A

Key findings: Melanotan II included in unauthorized peptide list. Unauthorized products may have unknown contamination and safety profiles.

Notes: Regulatory supply-chain source, not an efficacy trial.

FDA UNII entry for MELANOTAN II (UPF5CJ93X7).

Population: Chemical-substance registry context

Dose protocol: N/A

Key findings: UNII presence confirms identity metadata. It does not imply regulatory approval.

Notes: Good for identity validation, not clinical endorsement.