{
  "data": {
    "id": "mots-c",
    "canonicalName": "MOTS-c",
    "aliases": [],
    "exactForm": "pending",
    "route": "pending",
    "dosageForm": "pending",
    "intendedUse": "human use (unspecified)",
    "productStatus": "Not verified",
    "compoundingStatus": "Not verified",
    "evidenceTier": "9 registered clinical studies",
    "answer": "MOTS-c is listed in the CompoundedGuide registry with no verified FDA-approved product. FDA lists MOTS-c among bulk drug substances for use in compounding that may present significant safety risks. MOTS-c is not on FDA's 503B Bulks List for outsourcing facilities (list checked 2026-07-25). 9 registered ClinicalTrials.gov studies cite MOTS-c (5 recruiting, 1 active not recruiting, 1 completed, 1 not yet recruiting, 1 unknown); 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 9 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": "2026-07-25T19:17:36.478Z"
      },
      {
        "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": "2026-07-25T04:39:33.522Z"
      },
      {
        "id": "clinicaltrials_gov_api",
        "title": "ClinicalTrials.gov API v2",
        "authorityTier": "P0",
        "url": "https://clinicaltrials.gov/api/v2/studies?filter.ids=NCT03878706,NCT04013568,NCT04027712,NCT06133946,NCT06500975,NCT07438002,NCT07505745,NCT07638696,NCT07678073&pageSize=50&countTotal=true",
        "retrievedAt": "2026-07-25T01:36:46.019Z"
      }
    ],
    "trials": [
      {
        "nctId": "NCT07638696",
        "title": "Mitophagy and Mitochondrial DNA Dynamics During Ramadan Dry Fasting vs 16:8 Time-Restricted Feeding",
        "status": "NOT_YET_RECRUITING",
        "phase": "",
        "startYear": "2027"
      },
      {
        "nctId": "NCT07678073",
        "title": "Comparison of the Effects of General Anesthesia and Combined Spinal-Epidural Anesthesia on Ferroptosis, Humanin and MOTS-c Levels in Renal Transplantation",
        "status": "RECRUITING",
        "phase": "NA",
        "startYear": "2026"
      },
      {
        "nctId": "NCT07505745",
        "title": "MOTS-c for Improving Insulin Sensitivity in Adults With Prediabetes and Overweight/Obesity",
        "status": "RECRUITING",
        "phase": "PHASE2",
        "startYear": "2026"
      },
      {
        "nctId": "NCT07438002",
        "title": "Analysis of Effects of High-intensity Physical Exercise in Subjects With Dialyzed Chronic Kidney Disease and in Conservative Treatment",
        "status": "RECRUITING",
        "phase": "NA",
        "startYear": "2025"
      },
      {
        "nctId": "NCT06500975",
        "title": "Long Term Outcomes After Vestibular Implantation",
        "status": "RECRUITING",
        "phase": "NA",
        "startYear": "2024"
      },
      {
        "nctId": "NCT04013568",
        "title": "Exercise Post-Diagnosis of Breast Cancer",
        "status": "COMPLETED",
        "phase": "NA",
        "startYear": "2019"
      },
      {
        "nctId": "NCT03878706",
        "title": "The Cardiovascular Effect of GLP-1 Agonist, SGLT2 Inhibitor and Their Combination",
        "status": "RECRUITING",
        "phase": "",
        "startYear": "2017"
      },
      {
        "nctId": "NCT06133946",
        "title": "Cohort Of DEafness-gene Screening",
        "status": "ACTIVE_NOT_RECRUITING",
        "phase": "",
        "startYear": "2016"
      },
      {
        "nctId": "NCT04027712",
        "title": "Platelet Reactivity, B-amyloid, MOTS-c and Mortality of Type II Diabetics With CAD",
        "status": "UNKNOWN",
        "phase": "",
        "startYear": "2014"
      }
    ],
    "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"
      ]
    }
  }
}