{
  "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/epitalon",
  "canonicalUrl": "https://thepeptidefield.com/peptides/epitalon",
  "record": {
    "slug": "epitalon",
    "name": "Epitalon",
    "aliases": [
      "Epithalon",
      "AEDG",
      "epitalon acetate"
    ],
    "className": "Synthetic tetrapeptide",
    "family": "Longevity and cellular signaling",
    "sequenceLabel": "4 amino acids · Ala-Glu-Asp-Gly",
    "tier": "Insufficient",
    "evidenceContext": "Preclinical or formulation evidence",
    "statusLine": "No FDA-approved epitalon drug product",
    "productContext": "Similar names do not mean that products have the same evidence. Epitalon, epitalon acetate, and older pineal extracts such as epithalamin are not automatically interchangeable evidence objects.",
    "approvedProducts": [],
    "indications": [
      "No FDA-approved indication"
    ],
    "profile": {
      "humanOutcomes": {
        "level": "Unclear",
        "note": "FDA found no studies establishing insomnia outcomes for the nominated epitalon substances and route."
      },
      "humanPharmacology": {
        "level": "Limited",
        "note": "Melatonin and cell-line findings are indirect and do not establish patient benefit."
      },
      "safetyKnowledge": {
        "level": "Unclear",
        "note": "Human product, route, exposure, impurity, and long-term safety data are inadequate."
      },
      "productCertainty": {
        "level": "Unclear",
        "note": "Evidence often mixes epitalon, epitalon acetate, and non-identical pineal preparations."
      }
    },
    "oneLine": "A four-amino-acid peptide promoted for sleep and longevity. Its evidence has identity-transfer problems and no established insomnia or lifespan outcome evidence.",
    "reviewedAt": "July 23, 2026",
    "reviewedAtISO": "2026-07-23",
    "reviewHistory": [
      {
        "date": "2026-07-23",
        "note": "Initial brief reflects FDA's July 2026 insomnia-focused evidence review before final agency action."
      }
    ],
    "whatItIs": "Epitalon is a four-amino-acid peptide: Ala-Glu-Asp-Gly. It is often discussed with epithalamin, a pineal preparation, but they are not the same intervention.",
    "whatWeKnow": "Laboratory work has reported telomere-related effects in human cell lines. Telomeres are protective ends of chromosomes. FDA's current review found melatonin-related information but no clinical insomnia studies using the nominated substances by the proposed route.",
    "whatWeDoNotKnow": "Changes in cells grown in a laboratory do not establish slower aging, longer life, cancer prevention, or improved health in people. Evidence from epithalamin cannot be reassigned to epitalon.",
    "antiDoping": null,
    "safetyBoundary": "A claim about longer life needs long-term results in people, not only laboratory mechanisms. This guide provides no injectable, sleep-treatment, or anti-aging regimen.",
    "relatedSlugs": [
      "mots-c",
      "ghk-cu"
    ],
    "claims": [
      {
        "claim": "“Epitalon changes telomere biology in human cell lines.”",
        "verdict": "Supported with scope",
        "explanation": "A 2025 laboratory study reported telomere-length effects in cultured human cell lines.",
        "category": "Mechanism and biomarkers",
        "evidenceBasis": "Preclinical evidence",
        "scope": "Cultured cell lines, not health outcomes in treated people.",
        "sourceUrls": [
          "https://pubmed.ncbi.nlm.nih.gov/40908429/"
        ]
      },
      {
        "claim": "“Epitalon is proven to treat insomnia.”",
        "verdict": "Not established",
        "explanation": "FDA did not identify clinical insomnia studies of the nominated epitalon substances by the proposed route.",
        "category": "Clinical outcomes",
        "evidenceBasis": "No reliable human outcome evidence",
        "scope": "Adults with insomnia assessed using clinical sleep outcomes.",
        "sourceUrls": [
          "https://www.fda.gov/media/193345/download"
        ]
      },
      {
        "claim": "“Epitalon has been proven to extend human lifespan.”",
        "verdict": "Not established",
        "explanation": "The evidence does not provide reliable product-specific randomized lifespan outcomes for epitalon.",
        "category": "Longevity",
        "evidenceBasis": "No reliable human outcome evidence",
        "scope": "Human lifespan and healthspan outcomes attributable to epitalon.",
        "sourceUrls": [
          "https://www.fda.gov/media/193345/download"
        ]
      }
    ],
    "sources": [
      {
        "label": "FDA briefing document for epitalon-related bulk drug substances",
        "publisher": "U.S. Food and Drug Administration",
        "url": "https://www.fda.gov/media/193345/download",
        "kind": "FDA review",
        "year": 2026,
        "accessedAt": "2026-07-23"
      },
      {
        "label": "Epitalon and telomere length in human cell lines",
        "publisher": "PubMed · Biogerontology",
        "url": "https://pubmed.ncbi.nlm.nih.gov/40908429/",
        "kind": "Preclinical",
        "year": 2025,
        "accessedAt": "2026-07-23"
      },
      {
        "label": "July 2026 Pharmacy Compounding Advisory Committee meeting",
        "publisher": "U.S. Food and Drug Administration",
        "url": "https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026",
        "kind": "Regulatory",
        "year": 2026,
        "accessedAt": "2026-07-23"
      }
    ],
    "productRecords": [],
    "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"
    }
  }
}