{
  "data": {
    "id": "sermorelin",
    "canonicalName": "Sermorelin",
    "aliases": [],
    "exactForm": "pending",
    "route": "pending",
    "dosageForm": "pending",
    "intendedUse": "human use (unspecified)",
    "productStatus": "Not verified",
    "compoundingStatus": "Not verified",
    "evidenceTier": "42 registered clinical studies",
    "answer": "Sermorelin is listed in the CompoundedGuide registry with no verified FDA-approved product. Sermorelin is not on FDA's 503B Bulks List for outsourcing facilities (list checked 2026-07-25). 42 registered ClinicalTrials.gov studies cite Sermorelin (28 completed, 6 terminated, 4 withdrawn, 3 recruiting, 1 unknown); registration is not evidence of approval, efficacy, or safety.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 42 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": "pending",
    "commercialPolicy": "none",
    "reviewedAt": "2026-07-25",
    "sources": [
      {
        "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": "2026-07-25T04:39:36.635Z"
      },
      {
        "id": "clinicaltrials_gov_api",
        "title": "ClinicalTrials.gov API v2",
        "authorityTier": "P0",
        "url": "https://clinicaltrials.gov/api/v2/studies?filter.ids=NCT00000380,NCT00004332,NCT00006073,NCT00123253,NCT00257712,NCT00324064,NCT00448747,NCT00507104,NCT00608023,NCT00638287,NCT00675506,NCT00720902,NCT00791843,NCT00795210,NCT00807365,NCT00850564,NCT01060488,NCT01088412,NCT01237041,NCT01263717,NCT01264497,NCT01359488,NCT01410799,NCT01632592,NCT01701973,NCT01788462,NCT01897844,NCT02012556,NCT02092779,NCT02196831,NCT02271282,NCT02507245,NCT02553603,NCT02736591,NCT02931474,NCT03018886,NCT03031535,NCT03226821,NCT03375788,NCT06554717,NCT06701071,NCT07481734&pageSize=50&countTotal=true",
        "retrievedAt": "2026-07-25T01:36:52.995Z"
      }
    ],
    "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": "NCT06701071",
        "title": "Evaluation of a Long Versus Short Clomid Protocol for Controlled Ovarian Stimulation",
        "status": "RECRUITING",
        "phase": "PHASE4",
        "startYear": "2025"
      },
      {
        "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": "NCT03226821",
        "title": "Body Composition and Adipose Tissue in HIV",
        "status": "TERMINATED",
        "phase": "PHASE4",
        "startYear": "2018"
      },
      {
        "nctId": "NCT03031535",
        "title": "Study of Intranasal Octreotide (DP1038) in Healthy Adult Volunteers",
        "status": "COMPLETED",
        "phase": "PHASE1",
        "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": "NCT02736591",
        "title": "Dehydroepiandrosterone Versus Growth Hormone in Women Undergoing ICSI With Expected Poor Ovarian Response",
        "status": "UNKNOWN",
        "phase": "PHASE3",
        "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": "NCT02507245",
        "title": "Observational Longitudinal Study in Children Affected by Idiopathic Growth Hormone Deficiency (GHD)",
        "status": "COMPLETED",
        "phase": "",
        "startYear": "2014"
      },
      {
        "nctId": "NCT02271282",
        "title": "Estradiol-Receptor Blockade in Older Men and Women",
        "status": "COMPLETED",
        "phase": "PHASE1",
        "startYear": "2014"
      },
      {
        "nctId": "NCT01897844",
        "title": "A Two Part Phase 1, Repeated Doses and Continuous Infusion Study With ITF2984 in Healthy Volunteers",
        "status": "COMPLETED",
        "phase": "PHASE1",
        "startYear": "2013"
      },
      {
        "nctId": "NCT01701973",
        "title": "Effect of DPP4 Inhibition on Growth Hormone Secretion",
        "status": "COMPLETED",
        "phase": "PHASE4",
        "startYear": "2013"
      },
      {
        "nctId": "NCT01788462",
        "title": "Egrifta Replacement and Sleep Disordered Breathing",
        "status": "WITHDRAWN",
        "phase": "",
        "startYear": "2012"
      },
      {
        "nctId": "NCT01410799",
        "title": "Three Month Treatment of Growth Hormone Releasing Hormone (GHRH) in the Elderly",
        "status": "TERMINATED",
        "phase": "PHASE2",
        "startYear": "2011"
      },
      {
        "nctId": "NCT01237041",
        "title": "Free Fatty Acids, Body Weight, and Growth Hormones Secretion in Children",
        "status": "TERMINATED",
        "phase": "PHASE1/PHASE2",
        "startYear": "2011"
      },
      {
        "nctId": "NCT01359488",
        "title": "VRS-317 in Adult Subjects With Growth Hormone Deficiency",
        "status": "COMPLETED",
        "phase": "PHASE1",
        "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": "NCT00720902",
        "title": "Adult Growth Hormone Deficiency and Cardiovascular Risk",
        "status": "TERMINATED",
        "phase": "PHASE4",
        "startYear": "2007"
      },
      {
        "nctId": "NCT00448747",
        "title": "Investigation of a New, Oral Growth Hormone Secretagogue, AEZS-130 as a Growth Hormone Stimulation Test.",
        "status": "COMPLETED",
        "phase": "PHASE3",
        "startYear": "2007"
      },
      {
        "nctId": "NCT00608023",
        "title": "TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy",
        "status": "COMPLETED",
        "phase": "PHASE3",
        "startYear": "2007"
      },
      {
        "nctId": "NCT00638287",
        "title": "Inter-Assay Growth Hormone and IGF-I Variability",
        "status": "WITHDRAWN",
        "phase": "",
        "startYear": "2007"
      },
      {
        "nctId": "NCT02092779",
        "title": "Growth Hormone Deficiency and Empty Sella Cardio-Metabolic Risk Factors in Obesity: a Cross-Sectional Study",
        "status": "COMPLETED",
        "phase": "",
        "startYear": "2007"
      },
      {
        "nctId": "NCT00324064",
        "title": "Sexually Dimorphic Effects of GHRH in Adult Growth Hormone Testing",
        "status": "COMPLETED",
        "phase": "NA",
        "startYear": "2007"
      },
      {
        "nctId": "NCT00807365",
        "title": "Six Month Treatment of Growth Hormone Releasing Hormone (GHRH) in the Elderly",
        "status": "TERMINATED",
        "phase": "PHASE2",
        "startYear": "2007"
      },
      {
        "nctId": "NCT00257712",
        "title": "SMART: Somatotrophics, Memory, and Aging Research Trial",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": "2006"
      },
      {
        "nctId": "NCT00507104",
        "title": "Pituitary Functions After Traumatic Brain Injury (TBI) and/or Subarachnoid Hemorrhage (SAH)",
        "status": "COMPLETED",
        "phase": "",
        "startYear": "2006"
      },
      {
        "nctId": "NCT00123253",
        "title": "TH9507 in Patients With HIV-Associated Lipodystrophy",
        "status": "COMPLETED",
        "phase": "PHASE3",
        "startYear": "2005"
      },
      {
        "nctId": "NCT00791843",
        "title": "The Effect of GHRH Therapy on Myocardial Structure and Function in Congestive Heart Failure",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": "2004"
      },
      {
        "nctId": "NCT01060488",
        "title": "Comparative Validation of the Growth Hormone Releasing Hormone and Arginine Test for the Diagnosis of Adult Growth Hormone Deficiency",
        "status": "COMPLETED",
        "phase": "PHASE3",
        "startYear": "2004"
      },
      {
        "nctId": "NCT01264497",
        "title": "Safety Study of TH9507 in Subjects With Stable, Type 2 Diabetes",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": "2002"
      },
      {
        "nctId": "NCT03018886",
        "title": "Diagnosing Adult Growth Hormone Deficiency",
        "status": "COMPLETED",
        "phase": "NA",
        "startYear": "2001"
      },
      {
        "nctId": "NCT00006073",
        "title": "Endocrine Studies in Health and Disease",
        "status": "TERMINATED",
        "phase": "",
        "startYear": "2000"
      },
      {
        "nctId": "NCT01088412",
        "title": "Observational Study of Somatropin Treatment in Children",
        "status": "COMPLETED",
        "phase": "",
        "startYear": "1999"
      },
      {
        "nctId": "NCT00000380",
        "title": "Growth Hormone Releasing Hormone (GHRH) Treatment for Age-Related Sleep Disturbances",
        "status": "COMPLETED",
        "phase": "NA",
        "startYear": "1996"
      },
      {
        "nctId": "NCT00004332",
        "title": "Study of the Effect of Growth Hormone-Releasing Hormone Antagonist on Growth Hormone Release in Acromegaly",
        "status": "COMPLETED",
        "phase": "",
        "startYear": "1993"
      }
    ],
    "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"
      ]
    }
  }
}