Melanotan I / Afamelanotide

What Melanotan I / Afamelanotide does

Melanotan I is also called afamelanotide, the active ingredient in Scenesse. The approved implant helps adults with EPP spend longer in light without painful reactions. Trials and long-term cohorts support that use. It is also studied for vitiligo and other conditions. Online tanning powders and sprays lack the implant's evidence and quality controls.

• Scenesse, an implant, is approved to help adults with EPP spend more time in light without pain. (Drug label)
• In one study of EPP patients on the implant, typical time in light before pain rose from 10 to 180 minutes. (Studied in a trial)
• In early studies, injections darkened skin while placebo did not, and one small test saw 47% fewer sunburn cells. (Studied in a trial)
• In a small trial, implants plus light therapy helped color return to skin patches in vitiligo. (Studied in a trial)

Uses in the sources

• Scenesse is FDA-approved to increase pain-free light exposure in adults with EPP. The EU indication is prevention of phototoxicity in adult EPP. (Drug label) (source)
• Implants plus narrowband UVB were studied for vitiligo. This remains investigational; cosmetic powder injections are not equivalent. (Studied in a trial) (source)
• Community users inject or spray products labeled melanotan I for tanning. There is no FDA tanning label. (Reported by users) (source)

Melanotan I / Afamelanotide dosage

Typical reported dose: One implant under the skin every 2 months

• US implant: every 2 months: Insert a single SCENESSE implant subcutaneously above the anterior supra-iliac crest every 2 months. every 2 months, under the skin. Drug label. Studied in: Adults with EPP. (source)
• EU implant: during light exposure: One implant is administered every 2 months prior to expected and during increased sunlight exposure. every 2 months, under the skin. Drug label. Studied in: Adults with EPP. (source)
• EPP pilot: two 20 mg implants: 20 mg sustained-release SC implant, twice 60 days apart. every 60 days, under the skin. Studied in a trial. Studied in: Adults with EPP. (source)
• US trial: three 16 mg implants: 16 mg SC implant on days 0,60,120. every 60 days, under the skin. Studied in a trial. Studied in: Adults with EPP. (source)
• EU trial: five 16 mg implants: 16 mg SC implant on days 0,60,120,180,240. every 60 days, under the skin. Studied in a trial. Studied in: Adults with EPP. (source)
• CUV030: three 16 mg implants: 16 mg SC implant on days 0,60,120. every 60 days, under the skin. Studied in a trial. Studied in: Adults with EPP. (source)

These are doses reported in labels, trials or user reports, not a personal plan. Check the source behind each one.

Work out syringe units with the dosing calculator

How to store Melanotan I / Afamelanotide

Comes as: Scenesse sterile bioresorbable implant, 16 mg in an amber glass vial.

Mixed with: None. A trained clinician inserts the implant; it is not dissolved in water..

• Allow the packaged implant to warm to room temperature before insertion.
• Observe for 30 minutes after insertion for an allergic reaction.

Before mixing: Refrigerate at 2–8°C and protect from light.

After mixing: Not applicable. The implant is a finished solid product.

Melanotan I / Afamelanotide side effects and risks

Reported side effects

• Implant-site reaction: 26/125, 21%, vs 12/119, 10%, vehicle., mild (source)
• Nausea: 24/125, 19%, vs 17/119, 14%, vehicle., moderate (source)
• Fatigue: 7/125, 6%, vs 3/119, 3%, vehicle., moderate (source)
• Skin hyperpigmentation: 5/125, 4%, vs 0/119 vehicle., mild (source)
• New or darker moles: Melanocytic nevus: 5/125, 4%, vs 2/119, 2%, vehicle., moderate (source)
• Dizziness: 5/125, 4%, vs 4/119, 3%, vehicle., moderate (source)
• Sleepiness: 3/125, 2%, vs 1/119, 1%, vehicle., moderate (source)
• Severe allergy or anaphylaxis: Reported after marketing; a reliable rate cannot be calculated., serious (source)

Stop and get help if

• Trouble breathing, faintness, hives or swelling of the mouth or throat after an implant.: Get emergency care immediately; a clinician may need to remove the implant.
• A new, changing, irregular or bleeding mole.: Arrange prompt dermatology assessment and pause further exposure.
• Spreading redness, pus, fever or persistent bleeding at the implant site.: Get prompt medical assessment.

Who should avoid it

• pregnant: EMA advises against use during pregnancy; human safety data are limited.
• breastfeeding: No infant safety data; EMA advises against use while breastfeeding.
• tryingToConceive: EMA requires effective contraception during use and for three months afterward.
• under18: Adult-only approval. Pediatric cases and PK studies do not establish routine pediatric safety.
• melanomaOrAtypicalMoles: US Scenesse labeling calls for twice-yearly full-body skin examinations and monitoring of pigmented lesions. Severe hypersensitivity is the formal US contraindication. Other jurisdictions may differ.
• kidneyDisease: Renal impairment is an EMA contraindication; US label says its PK effect is unknown.
• liverDisease: Hepatic impairment and severe liver disease are EMA contraindications.
• heartCondition: Significant cardiovascular disease was not adequately evaluated; EMA advises monitoring after each implant.
• seizureDisorder: Significant neurological disease, including seizures, was not adequately studied.
• bleedingDisorder: Implant insertion may cause bleeding, especially with blood-thinning medicines.
• other: Prior serious allergy to afamelanotide or implant ingredients is a formal contraindication.
• other: EMA advises against use over age 70; if used, monitor after every implant.

Interactions

• Anticoagulants, aspirin and NSAIDs: May increase bruising or bleeding at implantation. Warfarin, aspirin and NSAIDs are specifically named by EMA.
• Other melanocortin agonists: No combination interaction studies. Overlapping pigment and systemic effects are a precaution.
• NB-UVB phototherapy: Studied with implants for vitiligo under supervision. This does not establish safety of sunbeds or unsupervised UV exposure.

Product quality risks

• Online products labeled melanotan I are unregulated tanning products; the approved implant's release and safety data do not validate them.
• No independent product-testing series specific to online MT-I powder was confirmed in this search.
• A COA showing peptide purity does not establish sterility, endotoxin safety or implant-equivalent release.

What to expect

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.

Key studies

• First randomized tanning study: Active groups darkened significantly; placebo did not. Peak change 1–3 weeks after treatment. (source)
• Solution: injection, IV and oral PK: SC exposure was complete versus IV; no detectable drug after oral dosing. (source)
• Ten injections and skin biopsies: Mean forehead +49% in three participants; forearm +98% in seven, one week after dosing. (source)
• UVB study: 0.08 mg/kg: 3/4 active participants tanned; 47% fewer sunburn cells at the neck. (source)
• UVB study: 0.16 mg/kg: More skin sites darkened than in the lower-dose study; numerical arm effects not given. (source)
• Sunlight study: four weeks: Tanning lasted at least three weeks longer than sunlight-only control; controls needed 50% more sun exposure. (source)

Melanotan I / Afamelanotide FAQ

• Is Melanotan I / Afamelanotide FDA-approved? Yes: Scenesse (increase pain-free light exposure in adults with EPP.). Approval is formulation- and indication-specific. No separate 503B bulks-list entitlement or cosmetic tanning approval was confirmed.
• How do people take it? Under the skin, every 2 months. Source: drug label.
• What's the difference between Melanotan I / Afamelanotide and GHK-Cu? Melanotan I / Afamelanotide: the molecule in an approved EPP implant; online tanning powder is a different formulation. GHK-Cu: a copper-binding skin peptide with small topical studies and untested systemic injections. Why people pair them: community appearance stacks combine pigmentation and skin-focused goals.
• Can I take it with GHK-Cu? Community appearance stacks combine pigmentation and skin-focused goals. No controlled combination evidence; benefits cannot be assigned to one component. Source: reported by users. Ask a doctor before combining anything.
• Is it banned in sport? No, it is not on the banned list (WADA 2026). Inferred from the 2026 list and human drug approval: no named prohibition found; S0 does not apply to an approved substance. Verify the exact product.
• How do I store it once opened? Not applicable. The implant is a finished solid product.