{
  "data": {
    "id": "elamipretide",
    "canonicalName": "Elamipretide",
    "aliases": [
      "SS-31",
      "MTP-131"
    ],
    "exactForm": "pending",
    "route": "pending",
    "dosageForm": "pending",
    "intendedUse": "human use (unspecified)",
    "productStatus": "FDA-approved: FORZINITY (NDA215244)",
    "compoundingStatus": "Not verified",
    "evidenceTier": "FDA-approved product exists",
    "answer": "Elamipretide has FDA-approved prescription products (FORZINITY (NDA215244)). Elamipretide is not on FDA's 503B Bulks List for outsourcing facilities (list checked 2026-07-25). 21 registered ClinicalTrials.gov studies cite Elamipretide (14 completed, 3 terminated, 2 recruiting, 1 active not recruiting, 1 available); registration is not evidence of approval, efficacy, or safety. CompoundedGuide is verifying compounding status, safety signals, and current evidence. This is not medical advice.",
    "uncertainty": [
      "FDA approval status read from a captured openFDA Drugs@FDA response covering 1 application number.",
      "Approval data is not editorially reviewed; it reports what the FDA record says.",
      "Trial counts are read from a captured ClinicalTrials.gov response citing 21 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.",
      "Compounding status, shortage status, and safety profile are not yet verified.",
      "This is not a medical, legal, or professional endorsement."
    ],
    "lane": "approved",
    "commercialPolicy": "none",
    "reviewedAt": "2026-07-25",
    "sources": [
      {
        "id": "fda_openfda_drugsfda",
        "title": "openFDA Drugs@FDA",
        "authorityTier": "P0",
        "url": "https://api.fda.gov/drug/drugsfda.json?search=application_number%3A(%22NDA215244%22)&limit=50",
        "retrievedAt": "2026-07-25T13:21:04.128Z"
      },
      {
        "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": "2026-07-25T04:39:30.954Z"
      },
      {
        "id": "clinicaltrials_gov_api",
        "title": "ClinicalTrials.gov API v2",
        "authorityTier": "P0",
        "url": "https://clinicaltrials.gov/api/v2/studies?filter.ids=NCT01572909,NCT01755858,NCT02245620,NCT02367014,NCT02653391,NCT02693119,NCT02788747,NCT02805790,NCT02814097,NCT02848313,NCT02914665,NCT02976038,NCT03098797,NCT03323749,NCT03891875,NCT04689360,NCT05162768,NCT05168774,NCT06373731,NCT07275424,NCT07531251&pageSize=50&countTotal=true",
        "retrievedAt": "2026-07-25T01:36:40.429Z"
      }
    ],
    "trials": [
      {
        "nctId": "NCT07531251",
        "title": "Clinical Trial in Patients With Barth Syndrome- 4TAZPower",
        "status": "RECRUITING",
        "phase": "PHASE4",
        "startYear": "2026"
      },
      {
        "nctId": "NCT07275424",
        "title": "Study of Healthy Aging and Physical Function With Elamipretide",
        "status": "RECRUITING",
        "phase": "PHASE2",
        "startYear": "2025"
      },
      {
        "nctId": "NCT06373731",
        "title": "ReNEW:Phase 3 Study of Efficacy, Safety & Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects With Dry Age-Related Macular Degeneration (Dry AMD)",
        "status": "ACTIVE_NOT_RECRUITING",
        "phase": "PHASE3",
        "startYear": "2024"
      },
      {
        "nctId": "NCT05168774",
        "title": "FRDA Investigator Initiated Study (IIS) With Elamipretide",
        "status": "COMPLETED",
        "phase": "PHASE1/PHASE2",
        "startYear": "2022"
      },
      {
        "nctId": "NCT05162768",
        "title": "Study to Evaluate Efficacy and Safety of Elamipretide in Subjects With Primary Mitochondrial Disease From Nuclear DNA Mutations (nPMD)",
        "status": "COMPLETED",
        "phase": "PHASE3",
        "startYear": "2022"
      },
      {
        "nctId": "NCT03891875",
        "title": "ReCLAIM-2 Study to Evaluate Safety,Efficacy & Pharmacokinetics of Elamipretide in Subjects With AMD With Non-central GA",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": "2019"
      },
      {
        "nctId": "NCT03323749",
        "title": "A Trial to Evaluate Safety and Efficacy of Elamipretide Primary Mitochondrial Myopathy Followed by Open-Label Extension",
        "status": "TERMINATED",
        "phase": "PHASE3",
        "startYear": "2017"
      },
      {
        "nctId": "NCT03098797",
        "title": "A Trial to Evaluate Safety, Tolerability and Efficacy of Elamipretide in Subjects With Barth Syndrome",
        "status": "COMPLETED",
        "phase": "PHASE2/PHASE3",
        "startYear": "2017"
      },
      {
        "nctId": "NCT02848313",
        "title": "An Open-Label, Phase 1 Clinical Study to Evaluate the Safety and Tolerability of Subcutaneous Elamipretide in Subjects With Intermediate Age-Related Macular Degeneration",
        "status": "COMPLETED",
        "phase": "PHASE1",
        "startYear": "2016"
      },
      {
        "nctId": "NCT02653391",
        "title": "A Study Investigating the Safety, Tolerability, and Efficacy of Elamipretide Topical Ophthalmic Solution for the Treatment of Fuchs' Corneal Endothelial Dystrophy (FCED)",
        "status": "COMPLETED",
        "phase": "PHASE1/PHASE2",
        "startYear": "2016"
      },
      {
        "nctId": "NCT02693119",
        "title": "A Study Investigating the Safety, Tolerability, and Efficacy of Elamipretide Topical Ophthalmic Solution for Treatment of Leber's Hereditary Optic Neuropathy",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": "2016"
      },
      {
        "nctId": "NCT02914665",
        "title": "A Phase 2 Study to Evaluate the Cardiac and Renal Effects of Short Term Treatment With Elamipretide in Patients Hospitalized With Congestion Due to Heart Failure",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": "2016"
      },
      {
        "nctId": "NCT02805790",
        "title": "Safety, Tolerability, Efficacy of MTP-131 for Treatment of Mitochondrial Disease in Subjects From the MMPOWER Study",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": "2016"
      },
      {
        "nctId": "NCT02976038",
        "title": "Open-Label Extension Trial to Characterize the Long-term Safety and Tolerability of Elamipretide in Subjects With Genetically Confirmed Primary Mitochondrial Myopathy (PMM)",
        "status": "TERMINATED",
        "phase": "PHASE2",
        "startYear": "2016"
      },
      {
        "nctId": "NCT02814097",
        "title": "A Study to Evaluate the Effects of 4 Weeks Treatment With Subcutaneous Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Preserved Ejection Fraction",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": "2016"
      },
      {
        "nctId": "NCT02788747",
        "title": "Effect of Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Reduced Ejection Fraction",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": "2016"
      },
      {
        "nctId": "NCT02245620",
        "title": "A Phase 2 Study to Evaluate the Impact of MTP-131 (Bendavia™) on Skeletal Muscle Function in Elderly",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": "2015"
      },
      {
        "nctId": "NCT02367014",
        "title": "Safety, Tolerability, and Efficacy of MTP-131 for the Treatment of Mitochondrial Myopathy",
        "status": "COMPLETED",
        "phase": "PHASE1/PHASE2",
        "startYear": "2015"
      },
      {
        "nctId": "NCT01572909",
        "title": "Evaluation of Myocardial Effects of MTP-131 for Reducing Reperfusion Injury in Patients With Acute Coronary Events",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": "2012"
      },
      {
        "nctId": "NCT01755858",
        "title": "Effects of Intravenous Bendavia™ on Reperfusion Injury in Patients Undergoing Angioplasty of the Renal Artery",
        "status": "TERMINATED",
        "phase": "PHASE1/PHASE2",
        "startYear": "2012"
      },
      {
        "nctId": "NCT04689360",
        "title": "An Intermediate Size Expanded Access Protocol of Elamipretide",
        "status": "AVAILABLE",
        "phase": "",
        "startYear": ""
      }
    ],
    "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"
      ]
    }
  }
}