Compounds / Melanotan 1

Melanotan 1

Also known as: Afamelanotide; Melanotan I; MT-1; [Nle4-D-Phe7]-alpha-MSH; NDP-MSH; CAS 75921-69-6

FDA APPROVED Tier 1 – Approved Skin and Aesthetics

Primary research focus: Prevention of phototoxicity in erythropoietic protoporphyria (EPP)

Last updated July 2026 · Reviewed against FDA labeling and published research.

What is Melanotan 1?

Melanotan 1 (afamelanotide) is a synthetic 13-amino-acid analog of alpha-melanocyte-stimulating hormone (alpha-MSH) that selectively targets the melanocortin-1 receptor (MC1R), increasing eumelanin production in the skin without sun exposure. Unlike most compounds sold under this name, it is a genuinely FDA-approved prescription drug, marketed as Scenesse, a 16 mg subcutaneous implant approved in October 2019 for erythropoietic protoporphyria. There is no approved cosmetic tanning indication.

How it works

Afamelanotide is a melanocortin receptor agonist that binds predominantly to MC1R on melanocytes. Receptor activation increases synthesis of eumelanin, the darker, photoprotective form of melanin, independently of ultraviolet exposure. In erythropoietic protoporphyria, where accumulated protoporphyrin IX causes severe pain on light exposure, the resulting pigmentation increases pain-free light tolerance. It also has reported antioxidant and anti-inflammatory effects. Two substitutions in the alpha-MSH sequence (norleucine at position 4 and D-phenylalanine at position 7) confer potency and resistance to degradation.

How it’s supplied

Brand / trade names: Scenesse

Supplied as the FDA-approved product Scenesse: a 16 mg bioresorbable subcutaneous implant inserted above the anterior supra-iliac crest by a trained healthcare professional, typically every two months during periods of increased light exposure. It is not an injectable solution, tablet, or nasal spray. Products sold online as Melanotan-1 lyophilized powder are compounded or research-grade formulations, not the FDA-approved product, and have not been evaluated by the FDA for identity, purity, or potency.

Dosage Chart

RouteSubcutaneous
For reference only, compiled from FDA labeling, clinical trials, and established protocols. Not medical advice or a dosing recommendation. Confirm against current prescribing information and consult a qualified healthcare professional.
Vial size
BAC water

Units shown are for a U-100 insulin syringe (100 units = 1 mL), calculated from the vial size and BAC water you select. Always confirm against your prescription and your syringe markings.

PhaseDoseFrequencyNotes
Week 1 250mcg 1x Daily —
Week 2 500mcg 1x Daily —
Week 3 750mcg 1x Daily —
Weeks 4-8 1mg 1x Daily —
Week 9+ 1mg 1x Weekly —
Special considerations
  • Rotate injection sites to reduce irritation and lipohypertrophy
  • Not for use during pregnancy or breastfeeding
  • Do not exceed the recommended dose to try to speed results

Potential Benefits and Side Effects

Effects reported in published research. Not a promise of results, and not medical advice.

Reported benefits
  • Established, FDA-approved therapeutic effect for its indication.
  • Increases pain-free light exposure in adults with erythropoietic protoporphyria.
  • Induces photoprotective eumelanin pigmentation independently of UV exposure.
  • Reported antioxidant and anti-inflammatory effects.
  • Provides sustained effect from a single implant over approximately two months.
Reported side effects
  • Per the approved labeling, the most common adverse effects include implant-site reaction, nausea, oropharyngeal pain, cough, fatigue, and skin hyperpigmentation.
  • Dizziness, melanocytic nevus, respiratory tract infection, somnolence, non-acute porphyria, and skin irritation have also been reported.
  • Skin darkening is expected and requires periodic full-body skin examination.

Warnings and contraindications

Important safety information. This is not exhaustive — read the full prescribing information and consult your prescriber or pharmacist.

Warnings
  • Based on the FDA-approved labeling for Scenesse.
  • Skin darkening occurs and is expected; a full-body skin examination is recommended twice a year to monitor for melanocytic changes.
  • Patients should maintain sun-protection measures during treatment; the implant does not remove the need for photoprotection in EPP.
  • Hypersensitivity reactions can occur.
  • It must be administered by a healthcare professional trained in the subcutaneous implantation procedure.
  • There is no approved cosmetic tanning indication; unapproved Melanotan-1 products sold online are not the FDA-approved drug and are not quality-assured.
Contraindications
  • Per the approved labeling: known hypersensitivity to afamelanotide or any component of the implant. Clinician judgment is required in patients with hepatic or renal impairment and in those with a history of melanoma or significant melanocytic lesions.

Reconstitution Steps

How to prepare the lyophilized vial. Confirm specifics with your pharmacist or prescriber.

  1. The FDA-approved product (Scenesse) is a solid bioresorbable implant and is NOT reconstituted; it is inserted subcutaneously by a trained healthcare professional. The steps below describe handling only.
  2. Confirm the product is the 16 mg afamelanotide implant and check the expiration date.
  3. The implant is administered only by a healthcare professional proficient in the subcutaneous implantation procedure.
  4. Allow the implant to reach room temperature before the procedure, per the labeling.
  5. Prepare the insertion site (above the anterior supra-iliac crest) under sterile conditions.
  6. Insert the implant subcutaneously using the supplied applicator, per the approved technique.
  7. No dilution or concentration calculation applies to the approved implant; the reconstitution calculator on this page does not apply to Scenesse.
  8. Note: research-grade Melanotan-1 lyophilized powder is not the FDA-approved product and is not quality-assured.

US regulatory status

Classifications are public record but can change. For reference only, not legal advice.

DEA scheduleNot a controlled substance
Development stageFDA approved
503A compoundingNot eligible
503B compoundingNot eligible

Development: Afamelanotide was developed by Clinuvel Pharmaceuticals. It received EMA approval in December 2014 and FDA approval on October 8, 2019, following priority review and orphan drug designation. Approval was based on two parallel-group randomized trials in EPP patients: in the first, 93 patients (48 on afamelanotide) followed for 180 days showed a median 64 hours of pain-free direct sunlight versus 41 hours on placebo; a second trial over 270 days showed 6 hours versus 0.75 hours on the primary measure. It launched commercially in the US in April 2020 through a controlled distribution program. Afamelanotide has also been studied in other photodermatoses and in vitiligo, but EPP is its only approved indication.

Notes: Melanotan 1 (afamelanotide) is FDA-approved as Scenesse for increasing pain-free light exposure in adults with a history of phototoxic reactions from erythropoietic protoporphyria; it is also EMA-approved. It is available only by prescription through trained specialist implanters for that indication, and there is no approved cosmetic tanning indication. As an approved implant product it is not compounded; Melanotan-1 powders sold online are unapproved products outside FDA oversight. It is not a controlled substance.

International status

UKApproved for EPP (MHRA / post-EMA route)
EUApproved (EMA, December 2014) for EPP
AustraliaApproved (TGA) for EPP
CanadaNot broadly marketed (Health Canada); availability varies

Pharmacokinetics

Molecular weightApproximately 1,646.8 g/mol. A linear synthetic tridecapeptide (13 amino acids). CAS 75921-69-6.
Half-lifeApproximately 15 hours when administered subcutaneously via the controlled-release implant.
Time to peakMedian Tmax is approximately 36 hours after implant placement (mean Cmax approximately 3.7 ng/mL); the last measurable concentration is typically at 96 hours post-dose, while the pigmentary effect persists far longer (visible within days, peaking around days 10 to 14).
ClearanceAfamelanotide may undergo hydrolysis; its metabolic profile has not been fully characterized per the approved labeling.
SequenceAc-Ser-Tyr-Ser-Nle-Glu-His-D-Phe-Arg-Trp-Gly-Lys-Pro-Val-NH2, a linear 13-amino-acid analog of alpha-MSH with norleucine substituted at position 4 and D-phenylalanine at position 7 (also known as [Nle4-D-Phe7]-alpha-MSH or NDP-MSH).

Storage and handling

TemperatureStore the Scenesse implant per the product labeling (refrigerated, 2 to 8 degrees C). It is handled and implanted by a trained healthcare professional.
Light sensitiveProtect from light; keep in the original packaging until administration.
Shelf lifePer the manufacturer expiration date on the implant packaging.
Reconstituted storageNot applicable to the FDA-approved product: Scenesse is a solid bioresorbable implant, not a reconstituted solution. Research-grade Melanotan-1 powder is not the approved product and has no FDA-established in-use dating.

Important Notes

Practical considerations for consistency and safety.

  • Melanotan 1 (afamelanotide) is a genuinely FDA-approved drug (Scenesse) for erythropoietic protoporphyria; it is NOT approved for cosmetic tanning.
  • The approved product is a 16 mg subcutaneous implant placed by a trained clinician, not an injectable powder.
  • Melanotan-1 vials sold online are not Scenesse and have not been FDA-evaluated for identity, purity, or potency.
  • It is distinct from Melanotan 2, which is MC1R-nonselective, unapproved anywhere, and carries substantially more safety concern.
  • Skin monitoring twice yearly is recommended during treatment.

Lifestyle Factors

  • Administered by a clinician every two months during periods of increased light exposure.
  • Sun-protection measures should be maintained during treatment; it does not replace photoprotection.

Related compounds

Important disclaimer

This page is an educational reference, not medical advice, a diagnosis, or a treatment recommendation, and not a substitute for your prescriber or pharmacist. Approval and regulatory status varies by compound and can change. Always confirm against current prescribing information and consult a qualified healthcare professional before making any decision about a medication.