Evidence Grade C — Moderate human evidence. 19 published studies, 13 human. 0 registered clinical trials.
Medically reviewed by a licensed medical professional
Melanotan I is the research name for the same molecule that is sold as the prescription medication Scenesse (afamelanotide) for a rare light-sensitivity condition. This entry covers its widespread unregulated use for cosmetic tanning — a purpose for which it has no approval. Products from unregulated sources are fundamentally different from the controlled pharmaceutical implant and lack quality assurance.
Melanotan I is also known by these brand and alternate names:
19 published studies: 13 human, 3 animal, 2 in-vitro, 8 reviews
Melanotan I is the same molecule as afamelanotide, which is approved as Scenesse (#42) exclusively for erythropoietic protoporphyria. It is not approved for cosmetic tanning or any other indication.
Melanotan I is widely available through unregulated channels for cosmetic tanning purposes. This use is not supported by regulatory approval, and the safety of chronic self-administration for cosmetic purposes has not been established through clinical trials. Products from unregulated sources lack pharmaceutical quality assurance. The approved product (Scenesse) is administered under medical supervision as a controlled-release subcutaneous implant — a fundamentally different delivery method from unregulated injectable products.
Melanotan I activates the MC1R melanocortin receptor on melanocytes, stimulating eumelanin production (the photoprotective brown-black pigment). This is the same mechanism by which the approved formulation (Scenesse) provides photoprotection in EPP. The mechanism is well established from both preclinical research and the approved product's regulatory dossier.
Research suggests the prescription version (Scenesse) has a solid evidence base for the rare condition EPP, with clinical trials showing meaningful improvements in light tolerance. Long-term melanoma risk monitoring spanning over 10 years has shown no signal to date. However, the unregulated use for cosmetic tanning is a completely different context. No clinical trials have established the safety of chronic self-administration for cosmetic purposes. The pharmaceutical product is a controlled-release subcutaneous implant given under medical supervision — unregulated injectable products offer none of these safeguards. Products from unregulated sources lack pharmaceutical quality assurance.
PeptideTrace tracks 0 registered clinical trials for Melanotan I sourced from ClinicalTrials.gov.
No trials registered on ClinicalTrials.gov for this compound.
Melanotan I (afamelanotide) is a 13-amino acid linear peptide, a superpotent alpha-MSH analogue designated [Nle4, D-Phe7]-alpha-MSH. Sequence: Ac-Ser-Tyr-Ser-Nle-Glu-His-D-Phe-Arg-Trp-Gly-Lys-Pro-Val-NH2. Molecular weight: 1,646.85 Da. CAS: 75921-69-6. Molecular formula: C78H111N21O19. Half-life approximately 30 min (free peptide); implant releases >90% by day 5. Tmax (implant): 36 hours. Brand name: Scenesse (Clinuvel Pharmaceuticals). Approved by EMA (Dec 2014), FDA (Oct 2019), TGA (Oct 2020) for erythropoietic protoporphyria (EPP). Formulated as a 16 mg subcutaneous biodegradable implant. Listed here as research_compound for grey-market context outside the approved EPP indication.
Research suggests afamelanotide binds MC1R on melanocytes, activating adenylate cyclase, increasing cAMP, activating PKA, phosphorylating CREB, and upregulating MITF transcription, which drives expression of melanogenic enzymes (tyrosinase). This shifts melanin production toward eumelanin (photoprotective black/brown pigment) over pheomelanin. Eumelanin acts as a neutral density filter absorbing all UV wavelengths, scavenges free radicals, and research suggests promotes DNA repair. Critically, it stimulates melanogenesis independent of UV exposure. In EPP, increased eumelanin research suggests absorbs sunlight before it reaches accumulated protoporphyrin IX, reducing phototoxic reactions.
Three pivotal Phase III RCTs enrolled 244 adult EPP subjects across 22 sites. Study CUV039 (US; N=93): median pain-free sunlight hours were 69.4 vs 40.8 hours (P=0.04). Study CUV029 (EU; N=74): pain-free sunlight hours were 5.63 vs 0.75 hours (P=0.005), with half as many phototoxic reactions (P=0.044). Quality of life (EPP-QoL) scores improved significantly: US trial day 60 mean 44.0 vs 23.4 (P<0.001); EU trial day 120 78.8 vs 63.6 (P=0.005). Photoprovocation testing showed minimum symptom dose increases of 208.3 vs 56.2 J/cm2 on hand (P=0.01). A post-marketing German PASS (N=200) research suggests confirms efficacy and safety in practice. NICE noted absolute benefits were small but acknowledged large impact for EPP patients. Full-body skin examination twice yearly is recommended.
The information on this page is provided for educational and research reference purposes only. This is not medical advice. Always consult a qualified healthcare professional before making any health-related decisions.
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GHK has no pharmaceutical authorisation. Small cosmetic studies of the copper-complexed form (GHK-Cu) have reported improvements in skin appearance measures. No pharmaceutical clinical trials for injectable use have been completed. As with GHK-Cu (#85), the cosmetic evidence base for topical use should be distinguished from claims about injectable use. Gene expression profiling studies have reported broad effects, but observational genomic changes do not constitute evidence of therapeutic efficacy. This entry overlaps substantially with GHK-Cu (#85).
GHK-Cu has no pharmaceutical authorisation from any regulatory agency. It is widely available as a cosmetic ingredient in over-the-counter skincare products, where it is marketed for skin conditioning. A small study comparing GHK-Cu cream to vitamin C and retinoic acid creams reported improvements in skin appearance measures. No pharmaceutical clinical trials for injectable GHK-Cu have been completed. The compound's cosmetic use (topical, in formulated skincare products) should be clearly distinguished from its unregulated availability as an injectable research compound. These represent fundamentally different risk profiles.
Argireline has no pharmaceutical authorisation. It is widely available as a cosmetic ingredient in over-the-counter skincare products. Small industry-sponsored studies have reported wrinkle depth reductions of 17–30% with topical application. The key scientific question is whether sufficient peptide penetrates intact skin to reach neuromuscular junctions and produce a meaningful effect. The molecule's size exceeds the conventional limit for transdermal absorption. Argireline's cosmetic use in formulated skincare products represents a fundamentally different risk profile from injectable use.
This content is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional before making decisions about your health.
