{
  "data": {
    "id": "ipamorelin",
    "canonicalName": "Ipamorelin",
    "aliases": [],
    "exactForm": "pending",
    "route": "pending",
    "dosageForm": "pending",
    "intendedUse": "human use (unspecified)",
    "productStatus": "Not verified",
    "compoundingStatus": "Not verified",
    "evidenceTier": "3 registered clinical studies",
    "answer": "Ipamorelin is listed in the CompoundedGuide registry with no verified FDA-approved product. FDA lists Ipamorelin among bulk drug substances for use in compounding that may present significant safety risks. Ipamorelin is not on FDA's 503B Bulks List for outsourcing facilities (list checked 2026-07-25). 3 registered ClinicalTrials.gov studies cite Ipamorelin (2 completed, 1 active not recruiting); registration is not evidence of approval, efficacy, or safety. Identity and regulatory status are pending source collection and editorial review. This is not medical advice.",
    "uncertainty": [
      "Exact form, route, and dosage form are not yet resolved.",
      "No FDA-approved product has been verified for this substance.",
      "Trial counts are read from a captured ClinicalTrials.gov response citing 3 specific study records, not from an open search.",
      "503B Bulks List membership was read from the list page captured 2026-07-25; being off that list is not itself a statement that compounding is lawful or unlawful.",
      "The FDA safety-risk listing is reported as published by FDA. CompoundedGuide has not independently assessed the risk, and the listing's exact status and route qualifiers are not yet editorially reviewed.",
      "Compounding status, shortage status, and safety profile are not yet verified.",
      "This is not a medical, legal, or professional endorsement."
    ],
    "lane": "pending",
    "commercialPolicy": "none",
    "reviewedAt": "2026-07-25",
    "sources": [
      {
        "id": "fda_significant_safety_risk",
        "title": "Bulk Drug Substances That May Present Significant Safety Risks",
        "authorityTier": "P0",
        "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
        "retrievedAt": "2026-07-25T19:17:35.663Z"
      },
      {
        "id": "fda_503b_bulks",
        "title": "503B Bulks List and Interim Categories",
        "authorityTier": "P0",
        "url": "https://www.fda.gov/drugs/human-drug-compounding/503b-bulk-drug-substances-list",
        "retrievedAt": "2026-07-25T04:39:32.002Z"
      },
      {
        "id": "clinicaltrials_gov_api",
        "title": "ClinicalTrials.gov API v2",
        "authorityTier": "P0",
        "url": "https://clinicaltrials.gov/api/v2/studies?filter.ids=NCT00672074,NCT01280344,NCT07717866&pageSize=50&countTotal=true",
        "retrievedAt": "2026-07-25T01:36:42.447Z"
      }
    ],
    "trials": [
      {
        "nctId": "NCT07717866",
        "title": "Trifecta Research Study",
        "status": "ACTIVE_NOT_RECRUITING",
        "phase": "",
        "startYear": "2022"
      },
      {
        "nctId": "NCT01280344",
        "title": "Safety and Efficacy of Ipamorelin Compared to Placebo for the Recovery of Gastrointestinal Function",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": "2011"
      },
      {
        "nctId": "NCT00672074",
        "title": "Safety and Efficacy of Ipamorelin for Management of Post-Operative Ileus",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": "2008"
      }
    ],
    "pendingResources": {
      "identity": [
        "FDA/NCATS GSRS or equivalent canonical identity source"
      ],
      "product_status": [
        "Drugs@FDA, Purple Book, Orange Book, DailyMed, or applicable primary FDA record"
      ],
      "compounding_status": [
        "FDA 503A/503B pages, Federal Register, docket, or applicable final/interim policy"
      ],
      "safety": [
        "FDA safety communication, warning, recall, FAERS signal context, or explicit absence statement"
      ],
      "evidence": [
        "ClinicalTrials.gov and PubMed/primary publication search"
      ],
      "state_or_facility": [
        "State board or FDA facility record when relevant"
      ]
    }
  }
}