{
  "data": {
    "id": "tesamorelin",
    "canonicalName": "Tesamorelin",
    "aliases": [],
    "exactForm": "pending",
    "route": "pending",
    "dosageForm": "pending",
    "intendedUse": "human use (unspecified)",
    "productStatus": "FDA-approved: EGRIFTA (BLA022505)",
    "compoundingStatus": "Not verified",
    "evidenceTier": "FDA-approved product exists",
    "answer": "Tesamorelin has FDA-approved prescription products (EGRIFTA (BLA022505)). Tesamorelin is not on FDA's 503B Bulks List for outsourcing facilities (list checked 2026-07-25). 24 registered ClinicalTrials.gov studies cite Tesamorelin (14 completed, 4 terminated, 3 recruiting, 3 withdrawn); registration is not evidence of approval, efficacy, or safety.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 24 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(%22BLA022505%22)&limit=50",
        "retrievedAt": "2026-07-25T13:21:13.411Z"
      },
      {
        "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": "2026-07-25T04:39:37.439Z"
      },
      {
        "id": "clinicaltrials_gov_api",
        "title": "ClinicalTrials.gov API v2",
        "authorityTier": "P0",
        "url": "https://clinicaltrials.gov/api/v2/studies?filter.ids=NCT00123253,NCT00257712,NCT00608023,NCT00675506,NCT00795210,NCT00850564,NCT01263717,NCT01264497,NCT01388920,NCT01579695,NCT01591902,NCT01632592,NCT01788462,NCT02012556,NCT02196831,NCT02553603,NCT02572323,NCT02931474,NCT03150511,NCT03226821,NCT03375788,NCT03826160,NCT06554717,NCT07481734&pageSize=50&countTotal=true",
        "retrievedAt": "2026-07-25T01:36:54.741Z"
      }
    ],
    "trials": [
      {
        "nctId": "NCT07481734",
        "title": "Tesamorelin for Reduction of Liver Fat in Adults With Fatty Liver Disease (Mock Study)",
        "status": "RECRUITING",
        "phase": "PHASE2",
        "startYear": "2026"
      },
      {
        "nctId": "NCT06554717",
        "title": "Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV",
        "status": "RECRUITING",
        "phase": "PHASE2",
        "startYear": "2025"
      },
      {
        "nctId": "NCT03375788",
        "title": "Growth Hormone Releasing Hormone Analog to Improve Nonalcoholic Fatty Liver Disease and Associated Cardiovascular Risk",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": "2019"
      },
      {
        "nctId": "NCT03826160",
        "title": "Growth Hormone Dynamics and Cardiac Steatosis in HIV",
        "status": "COMPLETED",
        "phase": "",
        "startYear": "2019"
      },
      {
        "nctId": "NCT03150511",
        "title": "Tesamorelin to Improve Functional Outcomes After Peripheral Nerve Injury",
        "status": "RECRUITING",
        "phase": "PHASE2",
        "startYear": "2018"
      },
      {
        "nctId": "NCT03226821",
        "title": "Body Composition and Adipose Tissue in HIV",
        "status": "TERMINATED",
        "phase": "PHASE4",
        "startYear": "2018"
      },
      {
        "nctId": "NCT02572323",
        "title": "Phase II Trial of Tesamorelin for Cognition in Aging HIV-Infected Persons",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": "2017"
      },
      {
        "nctId": "NCT02553603",
        "title": "The Effect of Growth Hormone Releasing Hormone on Cognitive Function in Individuals With Mild Cognitive Impairment",
        "status": "COMPLETED",
        "phase": "PHASE1",
        "startYear": "2017"
      },
      {
        "nctId": "NCT02931474",
        "title": "Impact of GHRH on Sleep Promotion and Endocrine Regulation in Service Members Who Sustained a Traumatic Brain Injury and Have Current Insomnia",
        "status": "WITHDRAWN",
        "phase": "PHASE2",
        "startYear": "2016"
      },
      {
        "nctId": "NCT02196831",
        "title": "Tesamorelin Effects on Liver Fat and Histology in HIV",
        "status": "COMPLETED",
        "phase": "NA",
        "startYear": "2015"
      },
      {
        "nctId": "NCT01632592",
        "title": "Abdominal Obesity, Cardiovascular Inflammation, and Effects of Growth Hormone Releasing Hormone Analogue",
        "status": "WITHDRAWN",
        "phase": "NA",
        "startYear": "2014"
      },
      {
        "nctId": "NCT01579695",
        "title": "Long-term Observational Study in HIV Subjects Exposed to EGRIFTA®",
        "status": "TERMINATED",
        "phase": "",
        "startYear": "2013"
      },
      {
        "nctId": "NCT01591902",
        "title": "Diabetic Retinopathy in HIV Subjects Treated With EGRIFTA®",
        "status": "TERMINATED",
        "phase": "PHASE4",
        "startYear": "2012"
      },
      {
        "nctId": "NCT01788462",
        "title": "Egrifta Replacement and Sleep Disordered Breathing",
        "status": "WITHDRAWN",
        "phase": "",
        "startYear": "2012"
      },
      {
        "nctId": "NCT01388920",
        "title": "Efficacy and Safety Study of Tesamorelin in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Muscle Wasting",
        "status": "TERMINATED",
        "phase": "PHASE2",
        "startYear": "2011"
      },
      {
        "nctId": "NCT01263717",
        "title": "Effects of Growth Hormone Releasing Hormone in HIV",
        "status": "COMPLETED",
        "phase": "NA",
        "startYear": "2010"
      },
      {
        "nctId": "NCT00850564",
        "title": "Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men",
        "status": "COMPLETED",
        "phase": "NA",
        "startYear": "2009"
      },
      {
        "nctId": "NCT00795210",
        "title": "Effects of Short-term Growth Hormone in HIV-infected Patients",
        "status": "COMPLETED",
        "phase": "NA",
        "startYear": "2009"
      },
      {
        "nctId": "NCT02012556",
        "title": "Pharmacokinetic and Pharmacodynamic Study of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Positive Patients",
        "status": "COMPLETED",
        "phase": "PHASE1",
        "startYear": "2008"
      },
      {
        "nctId": "NCT00675506",
        "title": "Effectiveness of Growth Hormone Releasing Hormone in Reducing Abdominal Fat in People Who Are Obese",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": "2008"
      },
      {
        "nctId": "NCT00608023",
        "title": "TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy",
        "status": "COMPLETED",
        "phase": "PHASE3",
        "startYear": "2007"
      },
      {
        "nctId": "NCT00257712",
        "title": "SMART: Somatotrophics, Memory, and Aging Research Trial",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": "2006"
      },
      {
        "nctId": "NCT00123253",
        "title": "TH9507 in Patients With HIV-Associated Lipodystrophy",
        "status": "COMPLETED",
        "phase": "PHASE3",
        "startYear": "2005"
      },
      {
        "nctId": "NCT01264497",
        "title": "Safety Study of TH9507 in Subjects With Stable, Type 2 Diabetes",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": "2002"
      }
    ],
    "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"
      ]
    }
  }
}