{
  "schemaVersion": "peptidescanner-official-evidence-assessments/v1",
  "boundary": "Dated agency findings, not independent claims of worldwide evidence absence. No medical advice or endorsement.",
  "assessments": [
    {
      "peptideSlug": "cjc-1295",
      "version": 1,
      "publishedAt": "2026-09-15",
      "reviewedAt": "2026-09-15",
      "sourceId": "fda-cjc-1295-briefing-2024",
      "sourceUrl": "https://www.fda.gov/media/183819/download",
      "assessmentDate": "2024-11-15",
      "payloadSha256": "202fa022933ef27241c6e19f2156ca764854ccf4a7286e0fe1f1b6b56df39506",
      "documentPages": 72,
      "scope": "FDA's dated evaluation of five CJC-1295-related bulk substances. The briefing distinguishes DAC and non-DAC forms and is an advisory-stage assessment, not a final compounding rule.",
      "findings": [
        {
          "heading": "Which human evidence applies?",
          "text": "FDA describes the published studies as short studies of DAC forms in healthy adults. It identifies the 2009 proteomic report as a subset of the earlier Ionescu and Frohman study, rather than an independent participant cohort.",
          "pages": [
            40,
            42
          ]
        },
        {
          "heading": "What adverse effects were reported?",
          "text": "FDA reports injection-site reactions, headache, flushing and transient blood-pressure changes in the early studies. Limited exposure in healthy adults cannot establish longer-term safety or safety in growth hormone deficiency.",
          "pages": [
            40,
            41,
            42
          ]
        },
        {
          "heading": "Why the terminated trial matters",
          "text": "FDA cites anecdotal reports of a death during a terminated HIV-lipodystrophy trial and states that its results were unpublished. This is an agency account of those reports, not proof that CJC-1295 caused the death.",
          "pages": [
            40
          ]
        }
      ],
      "sourceTitle": "FDA evaluation of five CJC-1295-related bulk substances, November 15, 2024",
      "versionPath": "/peptides/cjc-1295/assessments/versions/1/"
    },
    {
      "peptideSlug": "ipamorelin",
      "version": 1,
      "publishedAt": "2026-09-15",
      "reviewedAt": "2026-09-15",
      "sourceId": "fda-ipamorelin-briefing-2024",
      "sourceUrl": "https://www.fda.gov/media/182088/download",
      "assessmentDate": "2024-08-19",
      "payloadSha256": "751d3a46471342fd83a14540bd4ed7fb2f802df89c71f1792c4d0abb2b7c671e",
      "documentPages": 55,
      "scope": "FDA's evaluation of ipamorelin free base and acetate for growth hormone deficiency and postoperative ileus, prepared for the October 2024 advisory meeting. It is a dated agency assessment, not a final compounding determination.",
      "findings": [
        {
          "heading": "Identity and approval scope",
          "text": "FDA distinguishes free base from acetate and states that neither was a component of an FDA-approved drug at the time of its assessment. Study reports did not always identify the form administered.",
          "pages": [
            6,
            35
          ]
        },
        {
          "heading": "What did FDA find about effectiveness?",
          "text": "FDA found insufficient evidence supporting the evaluated uses and no clinical effectiveness or safety data for the proposed subcutaneous route. Intravenous postoperative findings do not establish subcutaneous effectiveness.",
          "pages": [
            42,
            43
          ]
        },
        {
          "heading": "Serious events require explicit context",
          "text": "FDA reports two deaths among ipamorelin-treated postoperative patients, alongside higher rates of hypokalemia and hyperglycemia. The agency explicitly states that whether the deaths were related to ipamorelin is unclear.",
          "pages": [
            37,
            42
          ]
        }
      ],
      "sourceTitle": "FDA evaluation of ipamorelin-related bulk substances, August 19, 2024",
      "versionPath": "/peptides/ipamorelin/assessments/versions/1/"
    },
    {
      "peptideSlug": "kpv",
      "version": 1,
      "publishedAt": "2026-09-15",
      "reviewedAt": "2026-09-15",
      "sourceId": "fda-kpv-briefing",
      "sourceUrl": "https://www.fda.gov/media/193346/download",
      "assessmentDate": "2026-05-12",
      "documentPages": 38,
      "payloadSha256": "0253b86534700fc72a48cccab7b10c19201102da831ef7a8a28e8dab09fea254",
      "scope": "FDA's assessment of KPV free base and KPV acetate for the nominated uses of wound healing and inflammatory conditions. The assessment was prepared for the July 2026 Pharmacy Compounding Advisory Committee meeting.",
      "findings": [
        {
          "heading": "What did FDA find about human studies?",
          "text": "FDA reported that its search did not identify studies of KPV administered to humans. It concluded that evidence was insufficient to evaluate effectiveness for the nominated uses.",
          "pages": [
            20,
            21
          ]
        },
        {
          "heading": "Why human skin research is different",
          "text": "FDA identified a skin-permeation study using human cadaver skin among the nomination references. That is not a study of KPV treatment in living participants.",
          "pages": [
            20
          ]
        },
        {
          "heading": "What is known about harms?",
          "text": "FDA reported no identified human pharmacokinetic studies or clinical safety studies. Its adverse-event searches through December 3, 2025 did not identify qualifying reports; the agency states that potential safety risks in humans are unknown.",
          "pages": [
            25,
            26
          ]
        }
      ],
      "sourceTitle": "FDA briefing document for KPV",
      "versionPath": "/peptides/kpv/assessments/versions/1/"
    },
    {
      "peptideSlug": "tb-500",
      "version": 1,
      "publishedAt": "2026-09-15",
      "reviewedAt": "2026-09-15",
      "sourceId": "fda-tb-500-briefing",
      "sourceUrl": "https://www.fda.gov/media/193349/download",
      "assessmentDate": "2026-05-15",
      "documentPages": 41,
      "payloadSha256": "973cffba12fec26da77d67b3e08604500b754eaa48d15912acb9596f3090b5a4",
      "scope": "FDA's assessment of TB-500 free base and TB-500 acetate for the nominated use of wound healing. The assessment was prepared for the July 2026 Pharmacy Compounding Advisory Committee meeting.",
      "findings": [
        {
          "heading": "Which substance is being assessed?",
          "text": "FDA describes TB-500 free base as an N-terminal acetylated seven-amino-acid fragment of thymosin beta-4. It also warns that the common name has been used for different substances. Findings about full-length thymosin beta-4 cannot be assumed to apply to this fragment.",
          "pages": [
            7,
            8
          ]
        },
        {
          "heading": "What did FDA find about human studies?",
          "text": "FDA reported that it did not identify clinical studies of TB-500 administered to people and found insufficient evidence to evaluate effectiveness for wound healing. The nomination's references concerned thymosin beta-4 rather than human administration of the specified fragment.",
          "pages": [
            23,
            24
          ]
        },
        {
          "heading": "What is known about harms?",
          "text": "FDA reported no identified human pharmacokinetic or clinical safety studies. Its FAERS search through March 26, 2025 found no reports, while a separate complaint system contained two reports about blended TB-500 and BPC-157 without safety assessments. These findings do not establish safety or adverse-event rates.",
          "pages": [
            30,
            31
          ]
        }
      ],
      "sourceTitle": "FDA briefing document for TB-500",
      "versionPath": "/peptides/tb-500/assessments/versions/1/"
    }
  ]
}