Afamelanotide

Afamelanotide (also called Melanotan I) is a peptide best known for helping the skin tolerate more light by boosting its natural pigment, eumelanin, in people with a rare condition called erythropoietic protoporphyria (EPP). It's a synthetic version of the hormone alpha-MSH. It is FDA-approved, sold as Scenesse, as a solid implant inserted under the skin by a healthcare professional — and it's a different compound from Melanotan II, the unapproved 'tanning peptide' sold online.

Afamelanotide is best known for helping people with a rare light-sensitivity disorder called erythropoietic protoporphyria (EPP) tolerate more sunlight without pain, and it's FDA-approved for that exact use as Scenesse. Approval was based on two randomized controlled trials in EPP patients showing increased pain-free time in sunlight. That evidence is specific to this rare disease and the professionally administered implant — it does not describe the self-administered 'tanning' products sometimes sold online under the 'Melanotan I' name.

FDA-approved — Scenesse (NDA 210797, Clinuvel Pharmaceuticals), approved October 8, 2019, to increase pain-free light exposure in adults with a history of phototoxic reactions from erythropoietic protoporphyria (EPP). Administered only by a trained healthcare professional as a subcutaneous implant. Not DEA-scheduled. WADA status: confirm against current edition (melanocortin agonists are not a standard listed class but verify before competition).

Afamelanotide is FDA-approved as a prescription implant administered only by a healthcare professional for a specific rare disease. Self- administered "Melanotan I" products sold online are not the approved implant. VialWise is a research and educational reference, not medical advice — consult a licensed professional.

⚠️ For research and educational purposes only. Afamelanotide (Scenesse) is an FDA-approved prescription drug administered only by a trained healthcare professional. Information in this entry is informational, not medical advice. Always consult appropriate professional guidance before any decisions.

⚠️ This is an implant, not an injectable — no reconstitution, no self-administration. Scenesse is a solid biodegradable controlled-release implant inserted subcutaneously above the anterior supra-iliac crest by a healthcare professional. There is no vial, no bacteriostatic water, no draw, and no syringe. The Vialwise reconstitution math does not apply.

⚠️ Afamelanotide (Melanotan I) is not Melanotan II. They are different molecules with different receptor selectivity and completely different regulatory status. Afamelanotide is an FDA-approved MC1-R-selective implant for a rare disease (EPP). Melanotan II is an unapproved research peptide and a non-selective MC1-R/MC4-R agonist sold illicitly for tanning and libido effects. Conflating the two is a common and consequential error. See [melanotan-ii.md](./melanotan-ii.md).

Afamelanotide is a first-in-class, FDA-approved melanocortin-1 receptor agonist, marketed by Clinuvel as Scenesse, approved in 2019 for a rare photodermatosis. It is the regulated, clinically studied member of the melanocortin family — distinct in every important way from the illicit research peptide Melanotan II.

Mechanism. Afamelanotide is a synthetic analog of α-melanocyte-stimulating hormone (α-MSH) with two amino-acid substitutions ([Nle4-D-Phe7]) that resist enzymatic degradation and extend its half-life relative to native α-MSH. It binds predominantly to the melanocortin-1 receptor (MC1-R) on melanocytes and stimulates production of eumelanin — the photoprotective form of melanin — independently of UV exposure. The increased eumelanin provides photoprotection, which is the basis for its use in erythropoietic protoporphyria (EPP), a condition where light exposure causes severe phototoxic pain.

Clinical development. Scenesse was approved by the FDA on October 8, 2019 to increase pain-free light exposure in adults with a history of phototoxic reactions from EPP. Approval was based on two randomized controlled trials demonstrating increased pain-free time in sunlight. It had earlier been approved in the European Union (2014). The controlled-release implant format delivers afamelanotide steadily over the dosing interval.

Why it's in this library. Afamelanotide is included as the FDA-approved educational counterpart to Melanotan II. A researcher encountering "Melanotan I" or "afamelanotide" should understand it is (a) a real approved drug, (b) for a specific rare disease, (c) an implant administered by professionals, and (d) not the same as the tanning/libido research peptide Melanotan II. The contrast is itself the educational value — consistent with Vialwise's honest-framing posture.

Regulatory status. FDA-approved (NDA 210797), prescription-only, professionally administered. Not DEA-scheduled. The illicit "Melanotan I" products sold online for self-administration are not the FDA-approved Scenesse implant and carry the same unregulated-product risks discussed in the Melanotan II entry.

Commonly reported

• Implant-site reaction (~21%)
• Nausea (~19%)
• Oropharyngeal pain (~7%)
• Fatigue (~6%)
• Skin hyperpigmentation (~4%), dizziness (~4%), melanocytic nevus (~4%), respiratory tract infection (~4%)

Serious

• Serious hypersensitivity reactions, including anaphylaxis
• New or changing skin lesions — because afamelanotide darkens skin and can affect nevi, a full-body skin examination is recommended twice yearly per the label

Hypersensitivity to afamelanotide or implant components.

Skin monitoring required — twice-yearly full-body skin examination per the label, given the darkening effect and potential to obscure or alter pigmented lesions.

Professional administration only — not for self-insertion.

Pregnancy/lactation — per label; limited data, professional judgment required.

Regulatory (US): prescription-only, professionally administered; not DEA-scheduled. Illicit self-administered "Melanotan I" online products are not the approved Scenesse implant.

Peptide

A short chain of amino acids, the building blocks of proteins. Many compounds in this library are peptides.

Melanocortin receptor agonist

a compound that activates the receptors controlling pigmentation and other effects.

Implant

a solid form inserted under the skin that releases medication over time.

Half-life

Roughly how long the body takes to clear half of a dose. A long half-life is why some compounds can be taken only once a week.

1. Clinuvel Pharmaceuticals. Scenesse (afamelanotide) implant, for subcutaneous use — prescribing information. US Food and Drug Administration, NDA 210797, approved October 8, 2019.
2. Afamelanotide pharmacokinetics — apparent half-life ~15 h, controlled-release subcutaneous implant.
3. Langendonk JG, Balwani M, Anderson KE, Bonkovsky HL, Anstey AV, Bissell DM, Bloomer J, Edwards C, Neumann NJ, et al. (2015). Afamelanotide for Erythropoietic Protoporphyria. New England Journal of Medicine, 373(1):48–59.(PMID 26132941)
4. Kim ES, Garnock-Jones KP. (2016). Afamelanotide: A Review in Erythropoietic Protoporphyria. American Journal of Clinical Dermatology, 17(2):179–185.(PMID 26979527)
5. World Anti-Doping Agency. The 2026 Prohibited List, International Standard (effective 1 January 2026). Afamelanotide is not listed (and "melanocortin" / "melanotan" do not appear).

• Melanotan II — same mechanism class
• PT-141 (Bremelanotide) — same mechanism class
• AHK-Cu — shared research area
• GHK-Cu — shared research area
• GLOW — shared research area
• KLOW — shared research area