Melanotan I / Afamelanotide: research

The molecule in an approved EPP implant; online tanning powder is a different formulation.

Also called: Melanotan-1, MT-I, MT1, NDP-α-MSH, NDP-MSH, Afamelanotide, CUV1647, Scenesse.

Melanocortin agonists · Predominantly MC1 melanocortin receptor agonist · Evidence: Approved drug.

60 human study records are listed, including 23 registrations, early dose studies and cohorts. Reports and participants overlap; this is not a unique-trial count.

Studies

• First randomized tanning study. rct, n=28, Healthy White men with skin types I–IV. Active groups darkened significantly; placebo did not. Peak change 1–3 weeks after treatment. (source)
• Solution: injection, IV and oral PK. crossover-rct, n=3, Three healthy male volunteers. SC exposure was complete versus IV; no detectable drug after oral dosing. (source)
• Ten injections and skin biopsies. single-arm, n=7, Six men and one woman, skin types III–IV. Mean forehead +49% in three participants; forearm +98% in seven, one week after dosing. (source)
• UVB study: 0.08 mg/kg. rct, n=8, Healthy adult volunteers. 3/4 active participants tanned; 47% fewer sunburn cells at the neck. (source)
• UVB study: 0.16 mg/kg. open-label, n=12, Healthy adult volunteers. More skin sites darkened than in the lower-dose study; numerical arm effects not given. (source)
• Sunlight study: four weeks. rct, n=8, Healthy adult volunteers. Tanning lasted at least three weeks longer than sunlight-only control; controls needed 50% more sun exposure. (source)
• Three 10-day injection cycles. rct, n=65, Fair-skinned White volunteers who completed the trial. Low-MED participants +41%; high-MED participants +12% with active drug; both P<0.0001 vs placebo. (source)
• MC1R genotype analysis. cohort, n=77, White volunteers from a randomized phase 2 pigmentation program. Active treatment increased melanin density versus placebo, P<0.001; variant MC1R carriers also responded. (source)
• EPP pilot: 20 mg implant. open-label, n=5, Adults with EPP. Photoprovocation tolerance improved, P=0.007; natural-sunlight tolerance was up to 24 times baseline. (source)
• CUV039: US pivotal trial. rct, n=93, Adults with EPP. The implant increased pain-free light exposure in adult EPP. (source)
• CUV029: EU pivotal trial. rct, n=74, Adults with EPP. The implant increased pain-free light exposure in adult EPP. (source)
• Acute stroke pilot. open-label, n=6, Adults with acute ischemic stroke unable to receive revascularization. One fatal recurrent stroke occurred, assessed as unrelated to study drug. (source)
• Vitiligo: modified trial. open-label, n=21, Adults with nonsegmental vitiligo. Results are posted; applicability is limited to the studied condition. (source)
• Vitiligo plus NB-UVB. rct, n=55, Adults with nonsegmental vitiligo. Combination improved repigmentation in a small randomized trial. (source)
• UV DNA-repair study. single-arm, n=10, Healthy adults with skin types I–III. COMPLETED; no results posted by 2026-10-18. (source)
• XP-C DNA-repair registration. single-arm, n=6, Adults with xeroderma pigmentosum C. UNKNOWN; no results posted by 2026-10-18. (source)
• Polymorphic light eruption trial. rct, n=31, People with polymorphic light eruption. Results are posted; applicability is limited to the studied condition. (source)
• Variegate porphyria pilot. single-arm, n=6, Adults with variegate porphyria. Results are posted; applicability is limited to the studied condition. (source)
• CUV017: EPP crossover. crossover-rct, n=100, Adults with EPP. Results are posted; applicability is limited to the studied condition. (source)
• Vitiligo monotherapy registration. single-arm, n=6, Adults with vitiligo of face and body. UNKNOWN; no results posted by 2026-10-18. (source)
• XP-C/V DNA-repair registration. single-arm, n=6, Adults with xeroderma pigmentosum C or V. UNKNOWN; no results posted by 2026-10-18. (source)
• Adolescent/adult EPP PK: phase 1/2. pk-study, n=28, Adolescent and adult EPP patients. Results are posted; applicability is limited to the studied condition. (source)
• CUV030: EPP confirmatory study. rct, n=77, Adults with EPP. Results are posted; applicability is limited to the studied condition. (source)
• EPP safety extension. open-label, n=16, Adult EPP study completers. Results are posted; applicability is limited to the studied condition. (source)
• Photodynamic therapy adjunct. rct, n=16, Patients receiving porfimer photodynamic therapy. Results are posted; applicability is limited to the studied condition. (source)
• Solar urticaria pilot. open-label, n=5, Patients with solar urticaria. COMPLETED; no results posted by 2026-10-18. (source)
• Earlier PLE trial. prospective observational, n=18, People with polymorphic light eruption. COMPLETED; no results posted by 2026-10-18. (source)
• Acne pilot. open-label, n=3, Adults with mild-to-moderate facial acne. Results are posted; applicability is limited to the studied condition. (source)
• Vitiligo: six monthly implants. rct, n=15, Adults with nonsegmental vitiligo. COMPLETED; no results posted by 2026-10-18. (source)
• Transplant actinic-keratosis study. rct, n=200, Organ transplant recipients. UNKNOWN; no results posted by 2026-10-18. (source)
• Vitiligo phase 3 registration. rct, n=200, Adults with nonsegmental vitiligo. ACTIVE NOT RECRUITING; no results posted by 2026-10-18. (source)
• Manufacturing comparison PK. pk-study, n=24, Healthy volunteers. COMPLETED; no results posted by 2026-10-18. (source)
• Hailey-Hailey pilot. open-label, n=2, Two patients with chronic Hailey-Hailey skin lesions. Both patients had 100% lesion clearance by day 60; no control group. (source)
• Early vitiligo case series. case-series, n=4, Four people with generalized vitiligo. All four had repigmentation within 2 days to 4 weeks after the first implant. (source)
• Vitiligo in Asian patients. open-label, Asian patients with nonsegmental vitiligo. A human report exists; the accessible PubMed record has no abstract. (source)
• CUV006: implant dose finding. pk-study, n=12, Healthy volunteers. 16 and 20 mg had comparable pigment effects in dose selection. (source)
• CUV007: implant dose finding. pk-study, n=6, Healthy volunteers. 10 mg showed a smaller pigment effect than 16 and 20 mg in cross-study comparisons. (source)
• CUV009: implant dose finding. pk-study, n=10, Healthy volunteers. Repeated 16 mg exposure supported implant dose selection. (source)
• CUV038: implant dose finding. pk-study, n=12, Healthy volunteers. Mean Cmax 3.65 ng/mL; AUC0-inf 138.9 hour·ng/mL; most last measurable levels at 96 hours. (source)
• Long-term EPP: 115 patients. cohort, n=115, Patients with EPP and, in some US studies, X-linked protoporphyria. 1,023 implants; quality-of-life score rose from 31±24% before use to 74% during use. (source)
• Swiss EPP: three years. cohort, n=39, Patients with EPP and, in some US studies, X-linked protoporphyria. Median light tolerance rose from 10 to 180 minutes; worst pain median fell from 10 to 6. (source)
• Dutch EPP: routine care. cohort, n=117, Patients with EPP and, in some US studies, X-linked protoporphyria. Mean extra outdoor time +6.1 hours/week, 95% CI 3.62–8.67; 115/117 continued. (source)
• German postauthorization cohort. cohort, n=200, Patients with EPP and, in some US studies, X-linked protoporphyria. 91.0% continued therapy; quality of life improved, P<0.0001. No untreated controls. (source)
• Austrian EPP cohort, 2026. cohort, n=20, Patients with EPP and, in some US studies, X-linked protoporphyria. Median light tolerance increased from 15 to 250 minutes; median EPP-QoL from 11.11 to 79.17. (source)
• Antibody safety study. cohort, n=26, Patients with EPP and, in some US studies, X-linked protoporphyria. No new drug-induced antibodies detected; three patients had pre-existing reactivity that did not increase. (source)
• Warning symptoms before pain. cohort, n=89, Patients with EPP and, in some US studies, X-linked protoporphyria. 31 US and 58 Dutch patients; time to warning symptoms improved in all US and 81% of Dutch participants. (source)
• Objective light-exposure study. cohort, n=49, Patients with EPP and, in some US studies, X-linked protoporphyria. 26 EPP patients and 23 controls; spring light exposure was 71.6% higher on afamelanotide than off it. (source)
• US quality-of-life cohort. cohort, Patients with EPP and, in some US studies, X-linked protoporphyria. A retrospective human cohort is indexed; quantitative results were not available from the PubMed abstract. (source)
• Five-patient quality-of-life study. cohort, n=5, Patients with EPP and, in some US studies, X-linked protoporphyria. Quality of life during therapy approximated the age-matched norm; treatment interruption worsened scores. (source)
• Liver lab dose-response analysis. cohort, n=70, Patients with EPP and, in some US studies, X-linked protoporphyria. 2,933 liver tests and 1,659 implants analyzed; ALT and bilirubin decreased with more doses in the prior year. (source)
• Swiss liver-lab cohort. cohort, n=38, Patients with EPP and, in some US studies, X-linked protoporphyria. Mean protoporphyrin 21.39→16.83 µmol/L; AST 26.67→22.9 IU/L. Association, not proof of liver protection. (source)
• US light-tolerance cohort. cohort, n=29, Patients with EPP and, in some US studies, X-linked protoporphyria. In the ≥2-implant subgroup, median light tolerance rose from 12.5 to 120 minutes. Liver tests did not improve. (source)
• Vitamin D cohort. cohort, n=230, Patients with EPP and, in some US studies, X-linked protoporphyria. 71.8% remained below 50 nmol/L on afamelanotide. Afamelanotide alone did not significantly raise vitamin D. (source)
• Bone-health cohort. cohort, n=139, Patients with EPP and, in some US studies, X-linked protoporphyria. Low bone density was common; afamelanotide did not improve bone mineral density. (source)
• Fern extract adjunct study. open-label, n=8, Patients with EPP and, in some US studies, X-linked protoporphyria. Six completed; quality of life improved at day 60, P=0.014, but not day 120, P=0.152. No adverse events. (source)
• Nine-year-old EPP case. case-report, n=1, A nine-year-old child with EPP. A pediatric case is reported; adult approval does not establish pediatric dosing. (source)
• Congenital porphyria case, 2026. case-report, n=1, 32-year-old woman described as having congenital erythropoietic porphyria. The patient reported improved light sensitivity and burning pain. (source)
• One implant and UV response, 2026. single-arm, n=9, Five men and four women, aged 27–43, skin types II–III. Mean erythema area-under-curve 3.5 before vs 2.7 after; P=0.018. (source)
• Early implant work in guinea pigs. animal, Guinea pigs and a frog-skin bioassay. Animal implant development does not establish a home-injection schedule. (source)
• Pale patches after injections. case-report, n=1, One patient with atopic dermatitis. The case describes uneven visible pigmentation; no accessible abstract supplies a dose. (source)
• Survey of melanotan users. cohort, Volunteers in an online forum survey of MT-I/MT-II use. A self-selected survey describes use; it cannot measure population risk. (source)

Gaps: The human record count includes study reports and registrations, not unique participants. Long-term cohorts overlap. The long-term melanoma risk of repeated cosmetic powder injections is unknown; implant cohorts do not settle that question. A standardized nasal or daily powder regimen, sterile shelf life and validated home-mixing instructions were not found. The early 1991 dose grid was not available from the abstract; it was not reconstructed from later reviews. Some older registry records omit implant strength, route or frequency. Missing details are kept unknown. No verified controlled evidence supports combining cosmetic MT-I with other unapproved appearance peptides.

Related to Melanotan I / Afamelanotide

• Bremelanotide: An as-needed injection for low libido before menopause; nausea is common.
• Melanotan II: An unapproved tanning peptide with small human trials and reports of serious harm.
• Setmelanotide: A daily injection approved for specific genetic obesity and acquired hypothalamic obesity.
• Retatrutide: An experimental weekly injection with phase 3 weight-loss results.
• GHK-Cu: A copper-binding skin peptide with small topical studies and untested systemic injections.

Melanotan I / Afamelanotide: the short version

Sources

• 503B Bulk Drug Substances List, FDA · FDA · 2026
• Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act, FDA · FDA · 2026
• Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, FDA · FDA · 2026
• Compounding and the FDA: Questions and Answers, FDA · FDA · 2026
• DailyMed - SCENESSE- afamelanotide implant, 2026
• Product information, 2026
• Scenesse, 2026
• SCENESSE afamelanotide (as acetate) 16 mg implant vial (327947), 2026
• Scenesse, INN-afamelanotide, 2026
• The 2026 Prohibited List, World Anti-Doping Agency · WADA · 2026
• Therapeutic Goods (Poisons Standard—October 2026) Instrument 2026, Australian Government · Australian Government · 2026
• Don’t risk using tanning products containing melanotan, 2025
• 4 Consideration of the evidence | Afamelanotide for treating erythropoietic protoporphyria | Guidance | NICE, 2024
• NDA/BLA Multi-disciplinary Review and Evaluation: NDA 210797 Scenesse (afamelanotide), 2019
• Acute impact of afamelanotide on UVR erythemal and melanogenic responses in healthy humans in vivo: an exploratory study., Griffin LL et al. · Photochemical & photobiological sciences : Official journal of the European Photochemistry Association and the European Society for Photobiology · 2026

Sources checked: 2026-10-18.

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