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Explore  /  Afamelanotide (Scenesse / Melanotan-1)

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Afamelanotide (Scenesse / Melanotan-1)

A

lead outcome

EPP — phototoxicity prevention / pain-free…

grades vary by outcome ↓

Peptide

also called — Afamelanotide · trade name Scenesse (Clinuvel) · Melanotan-1 / Melanotan I / MT-1 (the research-peptide name) · [Nle⁴, D-Phe⁷]-α-MSH (NDP-MSH) · CUV-1647

(approved:) photoprotection / EPP phototoxicity-preventionMC1R-driven eumelanin synthesis(gray-market, as "Melanotan-1":) cosmetic tanning

The approved melanocortin — and the anchor that closes the register's melanocortin trio. Three points make this entry land: (1) it is a genuinely FDA- and EMA-approved drug (Scenesse) — a first-in-class rare-disease therapy — for erythropoietic protoporphyria; (2) it is chemically identical to the gray-market "Melanotan-1" (same molecule, NDP-MSH) — the clean "approved formulation vs unregulated research peptide" split; (3) its MC1R-selectivity is exactly what distinguishes it from Melanotan II (#32, non-selective) and PT-141 (#46, MC4R-selective) — three peptides, one hormone family, three different receptor targets and three different fates.

In brief

Afamelanotide is a synthetic α-MSH analog and selective MC1R agonist — and a genuinely approved, first-in-class drug (Scenesse, EMA 2015 / FDA 2019) for the rare disease erythropoietic protoporphyria (EPP), where a ferrochelatase defect causes protoporphyrin IX to build up and makes sunlight excruciatingly painful. By activating MC1R, it drives eumelanin (brown-black pigment) production independent of UV exposure, plus antioxidant and DNA-repair effects — letting EPP patients tolerate far more light: in Phase 3, patients on afamelanotide spent ~64 hours in direct sunlight pain-free over 180 days vs ~41 on placebo. The twist that matters for this register: afamelanotide is chemically identical to the gray-market "Melanotan-1," and its MC1R-selectivity is exactly what separates it from its two famous cousins — Melanotan II (#32), a non-selective analog that also hits MC3R/MC4R/MC5R (hence tanning plus appetite/libido/side-effects), and PT-141/bremelanotide (#46), an MC4R-selective analog approved for sexual desire. One α-MSH family, three receptor-selectivity profiles, three completely different destinies — approved-for-skin, unapproved-and-broad, approved-for-sex.

Legal standing, by region

International

approved in Australia (TGA)

approved in Australia (TGA); available for EPP in various markets.

Evidence, by outcome

How we grade →

An honest grade per outcome — drawn from the evidence, not any catalogue. Hype and undemonstrated marketing claims grade low.

OutcomeEvidence base · effectGrade

EPP — phototoxicity prevention / pain-free light exposure (the approved use)

Approved, first-in-class for a genuine unmet need — but for an ultra-rare disease; effect is meaningful-but-modest (extra tolerated-light hours), not a cure; EU approval under exceptional circumstances

3 randomized vehicle-controlled Phase 3 trials (CUV029/030/039, 244 adults) → EMA 2015 + FDA 2019; ~64 vs ~41 pain-free sunlight hours/180 days

A

UV-independent skin pigmentation (eumelanin)

The core mechanism is real and reproducible; it is what the drug does

Robust, well-characterised pharmacology (MC1R → eumelanogenesis)

B

Cosmetic tanning (the gray-market "Melanotan-1" use)

The pathway works, but it's unapproved for cosmetics, uses an injectable systemic drug for vanity, and gray-market product quality is unverified; approved-disease data don't transfer to cosmetic safety

Mechanistically works (same eumelanin pathway); no approval for this indication

D

Other explored uses (vitiligo, PLE, solar urticaria, acne)

Mostly unpublished or not pursued; vitiligo saw some further work; not established

Early Clinuvel trials 2007-2011

D

Photoprotection in the general (non-EPP) population

The EPP approval is disease-specific; it is not a general "safe tanning / sun-protection" drug

Not an approved or established use

F

Safety

Implant-site reactions, nausea, oropharyngeal pain, cough, fatigue, skin hyperpigmentation, dizziness, melanocytic nevi (new/changing moles). A theoretical melanoma risk → full-body skin exam twice yearly is recommended; MC1R-selectivity gives it a cleaner systemic profile than Melanotan II

Approval-grade dataset (244 patients + post-marketing)

—

Disclosure

Vallydia sells its own cosmetic serums, and some ingredients graded here belong to the same categories as those products. Grades are drawn from the published evidence by the method we publish, and applied to our own ingredients on the same terms — our copper-peptide serum is graded no more kindly than the peptides it competes with. We disclose the interest so you can weigh it.

Trade names shown here (for example Matrixyl, Argireline, Syn-Ake) are the property of their respective owners and are used only to identify the ingredient under discussion. Their appearance implies no affiliation with, or endorsement by, the proprietor.

Evidence changes

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Identity

a synthetic linear 13-amino-acid peptide (tridecapeptide) analog of α-melanocyte-stimulating hormone (α-MSH), engineered as a potent, selective agonist of the melanocortin-1 receptor (MC1R) — the receptor on skin melanocytes that controls pigment. Developed by Clinuvel Pharmaceuticals. Critically, afamelanotide is the same molecule sold on the gray market as "Melanotan-1" — but here as a pharmaceutical-grade, controlled-release implant.

Mechanism (as proposed)

afamelanotide is a potent, MC1R-selective α-MSH analog (MC1R affinity ~0.3 nM, roughly 1,000× lower at MC3R/MC4R). MC1R sits on melanocytes; activating it shifts pigment synthesis toward eumelanin (brown-black, photoprotective) over pheomelanin, and does so without UV (bypassing the DNA-damage step that normal tanning requires). MC1R signalling also induces antioxidant activity, enhances DNA repair, and modulates inflammation — which is why, in EPP, more eumelanin plus these ancillary effects absorb/scatter light and blunt the protoporphyrin-IX phototoxic reaction. The Nle⁴/D-Phe⁷ substitutions are what give it the potency and metabolic stability the native hormone lacks.

Chemical identifiers

Cross-reference identifiers for the authoritative external databases — not a recipe, and nothing about how to use it.

PubChem CID16197727

InChIKeyUAHFGYDRQSXQEB-LEBBXHLNSA-N

SMILESCCCC[C@@H](C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CC1=CN=CN1)C(=O)N[C@H](CC2=CC=CC=C2)C(=O)N[C@@H](CCCNC(=N)N)C(=O)N[C@@H](CC3=CNC4=CC=CC=C43)C(=O)NCC(=O)N[C@@H](CCCCN)C(=O)N5CCC[C@H]5C(=O)N[C@@H](C(C)C)C(=O)N)NC(=O)[C@H](CO)NC(=O)[C@H](CC6=CC=C(C=C6)O)NC(=O)[C@H](CO)NC(=O)C

DrugBankDB04931

via PubChem exact-name match (Afamelanotide) · high confidence

Sources — 5 cited

01SCENESSE (afamelanotide) FDA label + FDA approval (Oct 2019, first-in-class); EMA authorisation (2015, exceptional circumstances).

02Sawyer TK, et al. [Nle⁴,D-Phe⁷]-α-MSH: a highly potent α-melanotropin with ultralong biological activity. PNAS. 1980 (the molecule's origin).

03Phase 3 EPP trials (CUV029, CUV030, CUV039); Medscape/NEJM-reported outcomes (~64 vs ~41 pain-free sunlight hours).

04Wensink D, et al. Afamelanotide for prevention of phototoxicity in erythropoietic protoporphyria. Expert Rev Clin Pharmacol. 2021 (review).

05Comparative melanocortin pharmacology (MC1R vs MC4R selectivity) — afamelanotide vs Melanotan II vs bremelanotide.

Updated 2026-07-13 (approval status stable; note ongoing post-marketing safety surveillance and any label/indication changes)

Grades reflect the published evidence, not our interest. No dosing, reconstitution, or administration is published for research compounds — that restraint is deliberate.

Related compounds

PT-141 (Bremelanotide)B

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