Editorial review · United States
Melanotan II
Source review:
Approval and product status
No approved product in any jurisdiction reviewed
A label on a vial or nasal spray does not show that its contents match the name. The reviewed records identify no approved melanotan II product or product label. Laboratory analysis of products sold as melanotan II found less material than the label claimed and found unidentified impurities.
This is the status described in the dated review. It is not a live FDA database check.
What was measured in people?
- Health outcomes · Limited
- No trial has tested whether using melanotan II makes anyone better off on any patient-centred endpoint.
- Body effects · Limited
- Two small human studies from 1996 and 2000 measured pigmentation and erectile response; no human pharmacokinetic or intranasal data was located.
A change in a hormone or body signal does not by itself prove a health benefit.
Limits that matter
Not independently medically reviewed. This tool does not recommend treatment.
Ischaemic priapism is a time-critical emergency: an erection persisting beyond about four hours needs immediate emergency care, because delay carries a risk of permanent erectile dysfunction. Anyone with a changing, darkening or new mole should be assessed by a clinician. This guide gives no dose, route, source or administration guidance, and none of the case-report harms below can be translated into a personal risk estimate.
Still unknown: The evidence does not show how often serious harms occur or what one person's risk is. The review found no phase 2 or phase 3 trial, no long-term safety study, no human study of nasal-spray absorption, and no comparison with afamelanotide. The case reports do not establish whether Melanotan II causes melanoma. Some reports also involved sunbeds or other ultraviolet exposure. No cohort or registry study was found. The frequency of serious harm is unknown; it is not known to be low.
This record cannot check a package, seller, batch, or personal treatment. It does not provide sport clearance.
Approval claims, with their sources
“Melanotan II is legal because it is sold as a research chemical.”
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.
Applies to: 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.
- Cancer Research UK: Fake tan and melanotan injections
- Therapeutic Goods Administration: Individual issued 27 infringement notices for allegedly supplying melanotan II
- PubMed · Drug Testing and Analysis: Identification and characterization by LC-UV-MS/MS of melanotan II skin-tanning products sold illegally on the internet
Exact product records in this review
These are selected records, not every product or form. A route means how a product enters the body.
No product label record is included here. That is not a separate approval decision. Read the status and sources above.
What the research shows
Two small studies in people found changes in pigment and sexual response, but they do not establish safe or effective use. The published harm record includes case reports of severe muscle breakdown, kidney injury, a prolonged painful erection that needed emergency treatment, and melanoma reported after melanotan use. These reports show that serious events were reported. They cannot show how often an event occurs or prove that Melanotan II caused each event.
Read all Melanotan II claims and their limitsSources used in the full review
A source is not support for every claim. Use the claim links above or the full review to check what each source supports.
- Evaluation of melanotan-II, a superpotent cyclic melanotropic peptide, in a pilot phase-I clinical study
PubMed · Life Sciences · Human pilot · 1996
Source accessed
- Melanocortin receptor agonists, penile erection, and sexual motivation: human studies with melanotan II
PubMed · International Journal of Impotence Research · Human pharmacology · 2000
Source accessed
- Melanotan II injection resulting in systemic toxicity and rhabdomyolysis
PubMed · Clinical Toxicology · Reference · 2012
Source accessed
- Melanotan II: a possible cause of renal infarction — review of the literature and case report
PubMed Central · CEN Case Reports · Reference · 2020
Source accessed
- Melanotan tanning injection: a rare cause of priapism
PubMed · Sexual Medicine · Reference · 2021
Source accessed
- Melanoma associated with the use of melanotan-II
PubMed · Dermatology · Reference · 2014
Source accessed
- Melanotan II nasal spray: a possible risk factor for oral mucosal malignant melanoma?
PubMed · International Journal of Oral and Maxillofacial Surgery · Reference · 2025
Source accessed
- Risks of unregulated use of alpha-melanocyte-stimulating hormone analogues: a review
PubMed · International Journal of Dermatology · Science review · 2017
Source accessed
- Identification and characterization by LC-UV-MS/MS of melanotan II skin-tanning products sold illegally on the internet
PubMed · Drug Testing and Analysis · Reference · 2015
Source accessed
- SCENESSE (afamelanotide) prescribing information
DailyMed · U.S. National Library of Medicine · Drug label · 2026
Source accessed
- VYLEESI (bremelanotide) prescribing information
DailyMed · U.S. National Library of Medicine · Drug label · 2026
Source accessed
- Scenesse European public assessment report
European Medicines Agency · Regulatory · 2014
Source accessed
- Fake tan and melanotan injections
Cancer Research UK · Reference · 2026
Source accessed
- Individual issued 27 infringement notices for allegedly supplying melanotan II
Therapeutic Goods Administration · Regulatory · 2024
Source accessed
- WADA Prohibited List
World Anti-Doping Agency · Anti-doping · 2026
Source accessed
- 2026 WADA Prohibited List summary
U.S. Anti-Doping Agency · Anti-doping · 2026
Source accessed