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FDA-approvedVendors pendingFacts verified · 2026-05-25

Afamelanotide

Also known as Melanotan-1, afamelanotide, ndp-α-msh, scenesse · Wikipedia

Melanotan-1 (afamelanotide, Scenesse) is a synthetic 13-amino-acid analog of alpha-melanocyte-stimulating hormone (alpha-MSH) with Nle4 and D-Phe7 substitutions that confer protease resistance and prolonged action. It is FDA-approved (October 2019) and EMA-approved (December 2014) as a 16 mg bioresorbable subcutaneous implant for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP). It acts as a melanocortin-receptor agonist with strongest activity at MC1R on melanocytes, increasing eumelanin density and skin photoprotection. Gray-market injectable lyophilized peptide is sold by peptide vendors for off-label cosmetic tanning, a use that lacks regulatory approval or controlled safety data.

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Mechanism of action

Afamelanotide is the synthetic linear tridecapeptide Ac-Ser-Tyr-Ser-Nle-Glu-His-D-Phe-Arg-Trp-Gly-Lys-Pro-Val-NH2. The Nle4/D-Phe7 modifications stabilize the molecule against proteolysis and increase melanocortin-receptor binding affinity relative to native alpha-MSH.

Afamelanotide is the synthetic linear tridecapeptide Ac-Ser-Tyr-Ser-Nle-Glu-His-D-Phe-Arg-Trp-Gly-Lys-Pro-Val-NH2. The Nle4/D-Phe7 modifications stabilize the molecule against proteolysis and increase melanocortin-receptor binding affinity relative to native alpha-MSH. It is a non-selective melanocortin-receptor agonist with highest potency at MC1R on cutaneous melanocytes; MC1R activation raises cAMP, induces MITF, and drives eumelanin synthesis - the photoprotective dark pigment that absorbs visible-light wavelengths implicated in EPP phototoxicity (Scenesse FDA label, 2019; Minder et al., PMID 26979527). Lower affinity at MC3R, MC4R, and MC5R produces fewer central effects than the more promiscuous MT-II. The 16 mg bioresorbable implant releases drug over ~2 months above the iliac crest, producing sustained pigmentation that reduces sun-induced pain in EPP (LiverTox NBK602608).

Pharmacokinetic properties

Half-life

Implant releases drug over ~2 months; circulating afamelanotide plasma half-life ~30 minutes; clinical pigmentation effect persists 50-60 days per implant

Routes

subcutaneous-implant · subcutaneous

Bioavailability

Scenesse is administered as a 16 mg controlled-release bioresorbable implant placed subcutaneously above the iliac crest, repeated every ~2 months. Gray-market vendors sell injectable lyophilized peptide for daily SC injection — not the approved formulation.

Amino-acid sequence

Ac-Ser-Tyr-Ser-Nle-Glu-His-D-Phe-Arg-Trp-Gly-Lys-Pro-Val-NH2

Use & research dosing

Skin TanningTanning

Research framing only. The FDA- and EMA-approved Scenesse regimen is a single 16 mg controlled-release bioresorbable subcutaneous implant placed above the iliac crest by a trained provider, repeated approximately every two months as needed during the spring-summer high-light season for adults with EPP. Gray-market injectable lyophilized melanotan-1 circulated for cosmetic tanning is typically reconstituted in bacteriostatic water and dosed 0.5-1.0 mg SC daily during a 'loading' phase, then less frequently; these protocols have no regulatory backing, no controlled human-safety data outside EPP, and uncertain product purity.

Research-use framing only. SavePeptides sells nothing for human consumption. Doses above reflect reported research / self-experimentation ranges, not clinical recommendations.

Editorial perspective

Afamelanotide has a clean regulatory history: orphan designation in the EU (2008), EMA marketing authorization under exceptional circumstances (December 2014), and FDA approval (October 2019) for EPP only. The injectable lyophilized 'Melanotan-1' sold by gray-market peptide vendors uses the same active molecule but a route, dose, and indication that have never been clinically validated for cosmetic tanning. Reports of new or atypical nevi and post-marketing melanoma cases have prompted ongoing pharmacovigilance even in the approved EPP setting.

— SavePeptides editorial desk · last updated 2026-05-25

Cautions & contraindications

Before researching this compound, note:

  • Approved Scenesse use restricted to EPP patients under specialist supervision
  • Off-label cosmetic tanning is not approved; safety outside EPP is uncharacterized
  • Skin darkening including new or atypical melanocytic nevi - full-body skin examinations advised every 6 months in EPP patients on Scenesse
  • Theoretical melanoma risk - melanoma cases have been reported post-marketing; causal relationship unclear
  • Gastrointestinal effects (nausea), headache, fatigue, dizziness, somnolence common
  • Injection-site reactions with both implant and gray-market injectable forms
  • Hypersensitivity reactions reported with unregulated injectable products
  • Hepatic impairment - data limited; Scenesse not studied in moderate/severe hepatic dysfunction
  • Pregnancy and breastfeeding - insufficient data; avoid
  • Unknown long-term consequences of chronic melanocortin-receptor activation in non-EPP users
  • Gray-market products are unregulated; purity, dose, and sterility are not independently verified

Research foundation

The papers behind the page.

  1. [01]https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210797s000lbl.pdf
  2. [02]https://www.ncbi.nlm.nih.gov/books/NBK602608/
  3. [03]https://www.ema.europa.eu/en/medicines/human/EPAR/scenesse
  4. [04]https://pubmed.ncbi.nlm.nih.gov/26979527/

Facts verified

2026-05-25

Confidence

high

What this means

  • fda-approved-2019
  • ema-approved-2014
  • gray-market-tanning-use-off-label

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