{
  "schemaVersion": "2.1",
  "datasetVersion": "2026-09-11.1",
  "generatedAt": "2026-09-11",
  "reviewStatus": "Editorial source review is complete. This edition has not been independently medically reviewed.",
  "editorialBoundary": "Source-checked educational summaries. Topics require evidence and editorial review. This dataset is not a personal treatment plan.",
  "citation": "When you cite a record, include The Peptide Field, its canonicalPath, this dataset version, and every source used for the claim.",
  "reuse": "This endpoint grants no additional reuse license. Keep the verdict, scope, evidence basis, review date, and source links together. Do not present a record as medical advice or medical review.",
  "changeLogPath": "/corrections#correction-ledger",
  "contactPath": "/corrections",
  "dataset": "peptide-evidence-checker-record",
  "canonicalPath": "/peptides/afamelanotide",
  "canonicalUrl": "https://thepeptidefield.com/peptides/afamelanotide",
  "record": {
    "slug": "afamelanotide",
    "name": "Afamelanotide",
    "aliases": [
      "Scenesse",
      "Nle4-D-Phe7-alpha-MSH",
      "melanocortin-1 agonist"
    ],
    "className": "Melanocortin-1 receptor agonist",
    "family": "Melanocortin medicines",
    "sequenceLabel": "13 amino acids · alpha-MSH analogue",
    "tier": "Established",
    "evidenceContext": "Approved human outcomes",
    "statusLine": "An FDA-approved implant exists for a rare-disease indication",
    "productContext": "Scenesse is not the same as every tanning peptide or injection. Scenesse is a healthcare-professional-administered implant. It is not equivalent to tanning peptides, compounded injections, or other melanocortin analogues.",
    "approvedProducts": [
      "Scenesse"
    ],
    "productRecords": [
      {
        "name": "Scenesse",
        "formulation": "Controlled-release implant",
        "route": "Subcutaneous implant administered by a trained professional",
        "indicationScope": "Increase pain-free light exposure in adults with erythropoietic protoporphyria and a history of phototoxic reactions.",
        "labelUrl": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210797s007lbl.pdf",
        "labelRevision": "2024 label"
      }
    ],
    "indications": [
      "Increase pain-free light exposure in adults with erythropoietic protoporphyria"
    ],
    "profile": {
      "humanOutcomes": {
        "level": "Strong",
        "note": "Randomized trials support pain-free light-exposure and quality-of-life outcomes in adults with EPP."
      },
      "humanPharmacology": {
        "level": "Strong",
        "note": "The approved implant's pharmacology and melanocortin-1 activity are characterized."
      },
      "safetyKnowledge": {
        "level": "Strong",
        "note": "The label and postauthorization monitoring characterize known risks and skin-monitoring requirements."
      },
      "productCertainty": {
        "level": "Strong",
        "note": "High for authentic Scenesse; low for transfer to other melanocortin products."
      }
    },
    "oneLine": "An approved implant that increases pain-free light exposure in adults with EPP. It is not a general tanning or cosmetic peptide.",
    "reviewedAt": "July 23, 2026",
    "reviewedAtISO": "2026-07-23",
    "reviewHistory": [
      {
        "date": "2026-07-23",
        "note": "Initial brief based on the current Scenesse label, pivotal trials, and orphan-drug record."
      }
    ],
    "whatItIs": "Afamelanotide is the active ingredient in the approved Scenesse implant. It is a changed version of a pigment-related body signal and acts mainly at the melanocortin-1 receptor.",
    "whatWeKnow": "Randomized trials in erythropoietic protoporphyria, or EPP, reported more pain-free light exposure and improvements in disease-specific quality of life. FDA approved Scenesse for a corresponding adult population.",
    "whatWeDoNotKnow": "The approval does not establish general tanning, cosmetic anti-aging, athletic, or other disease benefits. It does not validate different melanocortin peptides.",
    "antiDoping": null,
    "safetyBoundary": "The implant is administered by trained healthcare professionals and the label calls for skin monitoring. This guide provides no implant or cosmetic-use instructions.",
    "relatedSlugs": [
      "bremelanotide"
    ],
    "claims": [
      {
        "claim": "“Afamelanotide increases pain-free light exposure in adults with EPP.”",
        "verdict": "Supported with scope",
        "explanation": "The label and randomized trials support this defined rare-disease outcome.",
        "category": "Clinical outcomes",
        "evidenceBasis": "Randomized human outcomes",
        "scope": "Adults with a history of phototoxic reactions from erythropoietic protoporphyria.",
        "sourceUrls": [
          "https://pubmed.ncbi.nlm.nih.gov/26132941/",
          "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210797s007lbl.pdf"
        ]
      },
      {
        "claim": "“Scenesse is an approved cosmetic tanning implant.”",
        "verdict": "Misleading",
        "explanation": "Its approval is for pain-free light exposure in adults with EPP, not cosmetic tanning.",
        "category": "Approval and status",
        "evidenceBasis": "Regulatory or product record",
        "scope": "The current FDA-approved indication.",
        "sourceUrls": [
          "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210797s007lbl.pdf"
        ]
      },
      {
        "claim": "“Afamelanotide evidence proves other tanning peptides are safe and effective.”",
        "verdict": "Misleading",
        "explanation": "Different molecules and products require their own identity, quality, safety, and outcome evidence.",
        "category": "Product equivalence",
        "evidenceBasis": "Regulatory or product record",
        "scope": "Other melanocortin analogues and unapproved products.",
        "sourceUrls": [
          "https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=263208"
        ]
      }
    ],
    "sources": [
      {
        "label": "SCENESSE (afamelanotide) prescribing information",
        "publisher": "U.S. Food and Drug Administration",
        "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210797s007lbl.pdf",
        "kind": "Drug label",
        "year": 2024,
        "accessedAt": "2026-07-23"
      },
      {
        "label": "Afamelanotide for erythropoietic protoporphyria",
        "publisher": "PubMed · New England Journal of Medicine",
        "url": "https://pubmed.ncbi.nlm.nih.gov/26132941/",
        "kind": "Randomized trial",
        "year": 2015,
        "accessedAt": "2026-07-23"
      },
      {
        "label": "Afamelanotide orphan drug designation and approval",
        "publisher": "U.S. Food and Drug Administration",
        "url": "https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=263208",
        "kind": "Regulatory",
        "year": 2019,
        "accessedAt": "2026-07-23"
      }
    ],
    "antiDopingReview": {
      "status": "Not assessed",
      "detail": "This editorial review did not determine sport eligibility. Athletes must check the current prohibited list, Global DRO, and their governing body.",
      "sourceUrl": null,
      "reviewedAtISO": "2026-07-23"
    }
  }
}