{
  "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/aod-9604",
  "canonicalUrl": "https://thepeptidefield.com/peptides/aod-9604",
  "record": {
    "slug": "aod-9604",
    "name": "AOD-9604",
    "aliases": [
      "AOD9604",
      "lipotropin",
      "hGH fragment 176-191"
    ],
    "className": "Modified growth-hormone fragment",
    "family": "Metabolic peptide medicines",
    "sequenceLabel": "16 amino acids · modified hGH C-terminal fragment",
    "tier": "Insufficient",
    "evidenceContext": "Investigational human outcomes",
    "statusLine": "No FDA-approved AOD-9604 drug product",
    "productContext": "A study product, an injection, and a skin product are not automatically the same. Oral clinical-study material, compounded injections, and transdermal products are not interchangeable. FDA found route-specific evidence gaps.",
    "approvedProducts": [],
    "indications": [
      "No FDA-approved indication"
    ],
    "profile": {
      "humanOutcomes": {
        "level": "Limited",
        "note": "Older obesity studies exposed hundreds of participants, but the evidence did not establish an approved weight-loss use."
      },
      "humanPharmacology": {
        "level": "Limited",
        "note": "FDA found insufficient pharmacokinetic and pharmacodynamic information for proposed uses and routes."
      },
      "safetyKnowledge": {
        "level": "Limited",
        "note": "Clinical safety reporting is incomplete, and FDA identifies immunogenicity and impurity concerns."
      },
      "productCertainty": {
        "level": "Unclear",
        "note": "Identity, route, formulation, sterility, and comparability of compounded products are uncertain."
      }
    },
    "oneLine": "A modified piece of growth hormone studied in obesity programs. It has no approved use and unresolved route, product, and safety questions.",
    "reviewedAt": "July 23, 2026",
    "reviewedAtISO": "2026-07-23",
    "reviewHistory": [
      {
        "date": "2026-07-23",
        "note": "Initial brief based on FDA's 2024 compounding review and current safety-risk page."
      }
    ],
    "whatItIs": "AOD-9604 is a modified piece of human growth hormone, related to amino acids 176-191. It is not full-length growth hormone.",
    "whatWeKnow": "FDA reviewed several obesity studies in people, including larger oral programs, and documented the available adverse-event reporting. This confirms that people received it in studies. It does not establish a benefit.",
    "whatWeDoNotKnow": "The record does not establish meaningful weight loss, long-term benefit, or safety for injectable or transdermal products. FDA found no human information for some proposed routes of use.",
    "antiDoping": "AOD-9604 is named as a prohibited growth-hormone fragment on the 2026 WADA Prohibited List.",
    "antiDopingReview": {
      "status": "Prohibited",
      "detail": "AOD-9604 is named as a prohibited growth-hormone fragment on the 2026 WADA Prohibited List.",
      "sourceUrl": "https://www.wada-ama.org/en/resources/world-anti-doping-program/prohibited-list",
      "reviewedAtISO": "2026-07-23"
    },
    "safetyBoundary": "An incomplete development program does not provide instructions for self-treatment. No sourcing, reconstitution, injection, or weight-loss regimen is provided.",
    "relatedSlugs": [
      "mots-c",
      "semaglutide",
      "retatrutide"
    ],
    "claims": [
      {
        "claim": "“AOD-9604 has been given to people in clinical studies.”",
        "verdict": "Supported with scope",
        "explanation": "FDA's review describes several human studies, primarily using oral or intravenous routes.",
        "category": "Clinical outcomes",
        "evidenceBasis": "Regulatory or product record",
        "scope": "Historical study products and routes described in FDA's review.",
        "sourceUrls": [
          "https://www.fda.gov/media/183584/download"
        ]
      },
      {
        "claim": "“Human exposure proves AOD-9604 is an effective fat-loss drug.”",
        "verdict": "Misleading",
        "explanation": "Exposure and tolerability data do not establish a clinically meaningful weight-loss outcome.",
        "category": "Body composition",
        "evidenceBasis": "No reliable human outcome evidence",
        "scope": "Weight-loss efficacy, not merely participation in a study.",
        "sourceUrls": [
          "https://www.fda.gov/media/183584/download"
        ]
      },
      {
        "claim": "“Injectable AOD-9604 has a well-characterized safety profile.”",
        "verdict": "Not established",
        "explanation": "FDA identifies limited safety data, immunogenicity concerns, and missing information for proposed injectable use.",
        "category": "Safety",
        "evidenceBasis": "Regulatory or product record",
        "scope": "Compounded injectable AOD-9604.",
        "sourceUrls": [
          "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks"
        ]
      }
    ],
    "sources": [
      {
        "label": "FDA briefing document for AOD-9604-related bulk drug substances",
        "publisher": "U.S. Food and Drug Administration",
        "url": "https://www.fda.gov/media/183584/download",
        "kind": "FDA review",
        "year": 2024,
        "accessedAt": "2026-07-23"
      },
      {
        "label": "Bulk drug substances that may present significant safety risks",
        "publisher": "U.S. Food and Drug Administration",
        "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
        "kind": "Regulatory",
        "year": 2026,
        "accessedAt": "2026-07-23"
      },
      {
        "label": "Sterile compounded AOD-9604 recall for lack of sterility assurance",
        "publisher": "U.S. Food and Drug Administration",
        "url": "https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/innoveix-pharmaceuticals-inc-issues-voluntary-recall-all-sterile-compounded-drug-products-due-lack-0",
        "kind": "Regulatory",
        "year": 2021,
        "accessedAt": "2026-07-23"
      },
      {
        "label": "2026 Prohibited List",
        "publisher": "World Anti-Doping Agency",
        "url": "https://www.wada-ama.org/en/resources/world-anti-doping-program/prohibited-list",
        "kind": "Anti-doping",
        "year": 2026,
        "accessedAt": "2026-07-23"
      }
    ],
    "productRecords": []
  }
}