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Cosmetic & Other
Approved drug (for a specific indication)

Melanotan I

Afamelanotide

Afamelanotide — often called Melanotan I — is a selective melanocortin-1 receptor agonist FDA-approved as Scenesse, a subdermal implant that increases pain-free light exposure in adults with erythropoietic protoporphyria.

Regulatory status: FDA-approved as SCENESSE specifically to increase pain-free light exposure in adults with erythropoietic protoporphyria who have a history of phototoxic reactions. The label specifies a 16 mg implant every two months, inserted only by a trained healthcare professional. Cosmetic tanning is not an approved use.

Default vial

10 mg

Default mix

2 mL

Reported range

0.5–1 mg

Draw (U-100)

10 u

Subcutaneous
Every day
2w on / 2w off

More selective than Melanotan II, so far fewer flushing/nausea reports and no libido effect. Loading phase then maintenance 2–3x weekly.

What it is

  • A synthetic linear analogue of alpha-MSH and a selective MC1R agonist, per the approved label.
  • Delivered as a 16 mg subcutaneous implant — not an injection or nasal spray — placed by a clinician.
  • The approved indication is narrow: phototoxicity in erythropoietic protoporphyria.
  • It is the regulated counterpart to the unapproved Melanotan II sold online.

How it is described to act

  1. 1

    Placed as a subcutaneous implant every two months under the approved protocol.

  2. 2

    Releases afamelanotide gradually into the circulation.

  3. 3

    Selectively activates MC1R on melanocytes, stimulating eumelanin production.

  4. 4

    In the trials supporting approval this was associated with increased pain-free light exposure in EPP patients.

What the research has looked at

Basis of approval

  • The approved label states the drug is indicated to increase pain-free light exposure in patients with erythropoietic protoporphyria, based on the trials supporting approval.

Post-marketing safety in the label

  • The label documents reported serious hypersensitivity reactions including anaphylaxis, requiring implant removal and discontinuation if they occur.

Strength of evidence: Approved drug (for a specific indication)

Supported by an FDA-reviewed clinical programme for one narrow orphan indication. Nothing in the label supports use for general or cosmetic tanning.

This molecule is an approved medicine for at least one indication. Where that is the case, the approved prescribing information — not community convention — governs its use.

Reported cautions and unknowns

  • The label warns of serious hypersensitivity reactions, including anaphylaxis.
  • The label notes it may darken pre-existing moles and freckles, so skin monitoring is required.
  • It is contraindicated in known hypersensitivity to afamelanotide or the implant excipients.

References

  1. 1.SCENESSE (afamelanotide) FDA-approved prescribing information, DailyMed

Handling this vial

  • Lyophilized vials are generally stored at 2–8 °C and kept out of light; once reconstituted with bacteriostatic water they are refrigerated and commonly discarded after 28 days.
  • Mix by aiming water down the vial wall and rolling gently — do not shake — and never re-freeze a reconstituted vial.
  • Pep-Tidy cannot verify what is in your vial. Ask your supplier for a current Certificate of Analysis (HPLC/MS).

Melanotan I questions people ask

How do you reconstitute Melanotan I?

A common starting point for a 10 mg vial of Melanotan I is 2 mL of bacteriostatic water, which gives 5 mg per mL. Aim the water down the inside wall of the vial, let it dissolve on its own, and roll gently instead of shaking. Pep-Tidy's reconstitution calculator will recalculate the numbers for any other vial size or water volume you use.

How many units of Melanotan I is one dose?

At 5 mg per mL, that works out to about 10 units on a U-100 insulin syringe for a 500 mcg dose. Change the vial size, water volume, or target dose in the calculator and the syringe reading updates with it. This is arithmetic, not a dosing recommendation.

What dosing schedule is reported for Melanotan I?

Published and community sources describe 0.5–1 mg, subcutaneous, every day, typically run 2 weeks on and 2 weeks off. These figures describe what has been reported, not what anyone should take — talk to a licensed clinician first.

How should Melanotan I be stored?

Lyophilized Melanotan I vials are generally kept at 2–8 °C and out of light. Once reconstituted with bacteriostatic water they are refrigerated and commonly discarded after about 28 days. Never re-freeze a reconstituted vial and never shake it.

Read this before you act on anything above

Everything on this page is a summary of what other people have published — it is not medical advice, not a recommendation, and not a dosing instruction. Reported dose ranges describe what appears in the literature or in community protocols, not what anyone should take. Talk to a licensed clinician before using any peptide.

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