{
  "data": {
    "id": "mecasermin",
    "canonicalName": "Mecasermin",
    "aliases": [
      "Recombinant human IGF-1"
    ],
    "exactForm": "pending",
    "route": "pending",
    "dosageForm": "pending",
    "intendedUse": "human use (unspecified)",
    "productStatus": "FDA-approved: INCRELEX (BLA021839)",
    "compoundingStatus": "Not verified",
    "evidenceTier": "FDA-approved product exists",
    "answer": "Mecasermin has FDA-approved prescription products (INCRELEX (BLA021839)). Mecasermin is not on FDA's 503B Bulks List for outsourcing facilities (list checked 2026-07-25). 40 registered ClinicalTrials.gov studies cite Mecasermin (25 completed, 8 terminated, 4 recruiting, 1 not yet recruiting, 1 unknown, 1 withdrawn); registration is not evidence of approval, efficacy, or safety.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 40 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(%22BLA021839%22)&limit=50",
        "retrievedAt": "2026-07-25T13:21:07.943Z"
      },
      {
        "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": "2026-07-25T04:39:33.061Z"
      },
      {
        "id": "clinicaltrials_gov_api",
        "title": "ClinicalTrials.gov API v2",
        "authorityTier": "P0",
        "url": "https://clinicaltrials.gov/api/v2/studies?filter.ids=NCT00001669,NCT00004815,NCT00035815,NCT00125164,NCT00125190,NCT00330668,NCT00490100,NCT00516386,NCT00566241,NCT00571727,NCT00572156,NCT00720122,NCT00747604,NCT00764699,NCT00903110,NCT00915954,NCT01020955,NCT01096784,NCT01207908,NCT01253317,NCT01301183,NCT01314508,NCT01329744,NCT01406444,NCT01438086,NCT01446783,NCT01525901,NCT01588093,NCT01777542,NCT01970345,NCT02386839,NCT02636270,NCT02847481,NCT03087292,NCT03253263,NCT04085094,NCT06526637,NCT06602869,NCT06915428,NCT07399327&pageSize=50&countTotal=true",
        "retrievedAt": "2026-07-25T01:36:45.164Z"
      }
    ],
    "trials": [
      {
        "nctId": "NCT07399327",
        "title": "Biomarkers of Response to SEEG Thermocoagulation",
        "status": "RECRUITING",
        "phase": "NA",
        "startYear": "2026"
      },
      {
        "nctId": "NCT06915428",
        "title": "Personalized Care for Prenatal Stress Reduction & Prevention of Preterm Birth (PTB) Disparities",
        "status": "NOT_YET_RECRUITING",
        "phase": "NA",
        "startYear": "2026"
      },
      {
        "nctId": "NCT06602869",
        "title": "Cellular Markers in Treated or Untreated Non-tuberculous Mycobacterial Respiratory Infection in Patients With Cystic Fibrosis",
        "status": "RECRUITING",
        "phase": "",
        "startYear": "2024"
      },
      {
        "nctId": "NCT06526637",
        "title": "User Testing of an End of Life Medication Support Intervention for Lay Carers (Palliate).",
        "status": "COMPLETED",
        "phase": "NA",
        "startYear": "2024"
      },
      {
        "nctId": "NCT03253263",
        "title": "A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants",
        "status": "RECRUITING",
        "phase": "PHASE2",
        "startYear": "2019"
      },
      {
        "nctId": "NCT04085094",
        "title": "Gender Differences in Renal Functioning and Disease",
        "status": "COMPLETED",
        "phase": "",
        "startYear": "2017"
      },
      {
        "nctId": "NCT03087292",
        "title": "Low Intensity Resistance Training With Vascular Occlusion in Coronary Heart Disease Patients",
        "status": "UNKNOWN",
        "phase": "NA",
        "startYear": "2017"
      },
      {
        "nctId": "NCT02847481",
        "title": "A Study to Evaluate Fecal Microbiota Transplantation Engraftment in IBS",
        "status": "COMPLETED",
        "phase": "PHASE1",
        "startYear": "2016"
      },
      {
        "nctId": "NCT02386839",
        "title": "Long-term Safety and Efficacy Outcome Study Comparing Children Previously Enrolled in Study ROPP-2008-01 for the Prevention of Retinopathy of Prematurity (ROP)",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": "2015"
      },
      {
        "nctId": "NCT02636270",
        "title": "IGF-1 Treatment for Individuals With Short Stature Due to PAPP-A2 Deficiency",
        "status": "COMPLETED",
        "phase": "PHASE1/PHASE2",
        "startYear": "2015"
      },
      {
        "nctId": "NCT01970345",
        "title": "A Pilot Treatment Study of Insulin-Like Growth Factor-1 (IGF-1) in Autism Spectrum Disorder",
        "status": "TERMINATED",
        "phase": "PHASE2",
        "startYear": "2014"
      },
      {
        "nctId": "NCT01777542",
        "title": "Treatment of Rett Syndrome With Recombinant Human IGF-1",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": "2013"
      },
      {
        "nctId": "NCT01525901",
        "title": "Clinical Trial in 22q13 Deletion Syndrome(Phelan-McDermid Syndrome)",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": "2012"
      },
      {
        "nctId": "NCT01588093",
        "title": "IGF-I Induced Muscle Glucose Uptake and Interstitial IGF-I Concentrations",
        "status": "COMPLETED",
        "phase": "NA",
        "startYear": "2011"
      },
      {
        "nctId": "NCT01406444",
        "title": "IGF-1 and Bone Loss in Women With Anorexia Nervosa",
        "status": "COMPLETED",
        "phase": "NA",
        "startYear": "2011"
      },
      {
        "nctId": "NCT01438086",
        "title": "Evaluation of the Safety and Efficacy of Using Insulin-like Growth Factor-1 in Patients With a Heart Attack",
        "status": "COMPLETED",
        "phase": "PHASE1/PHASE2",
        "startYear": "2011"
      },
      {
        "nctId": "NCT01301183",
        "title": "Effects of Anorexia Nervosa on Peak Bone Mass",
        "status": "COMPLETED",
        "phase": "PHASE3",
        "startYear": "2011"
      },
      {
        "nctId": "NCT01314508",
        "title": "Increlex Treatment of Children With Chronic Liver Disease and Short Stature",
        "status": "WITHDRAWN",
        "phase": "NA",
        "startYear": "2011"
      },
      {
        "nctId": "NCT01329744",
        "title": "Effects of IGF-I in HIV Metabolic Disease",
        "status": "TERMINATED",
        "phase": "PHASE1",
        "startYear": "2011"
      },
      {
        "nctId": "NCT01446783",
        "title": "IGF-I Stimulation of Collagen Synthesis in Ehlers-Danlos Patients",
        "status": "COMPLETED",
        "phase": "NA",
        "startYear": "2011"
      },
      {
        "nctId": "NCT01253317",
        "title": "Treatment of Rett Syndrome With rhIGF-1 (Mecasermin [rDNA]Injection)",
        "status": "COMPLETED",
        "phase": "PHASE1",
        "startYear": "2010"
      },
      {
        "nctId": "NCT01096784",
        "title": "IGF-1/IGFBP3 Prevention of Retinopathy of Prematurity",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": "2010"
      },
      {
        "nctId": "NCT01207908",
        "title": "Safety and Efficacy Study of IGF-1 in Duchenne Muscular Dystrophy",
        "status": "COMPLETED",
        "phase": "PHASE1/PHASE2",
        "startYear": "2010"
      },
      {
        "nctId": "NCT01020955",
        "title": "Metabolic Effects of GH and IGF-I in Growth Hormone Deficient(GHD) and Diabetes and Impaired Glucose Tolerance(IGT)",
        "status": "COMPLETED",
        "phase": "PHASE3",
        "startYear": "2009"
      },
      {
        "nctId": "NCT00764699",
        "title": "Effect of Increlex® on Children With Crohn Disease",
        "status": "TERMINATED",
        "phase": "PHASE2/PHASE3",
        "startYear": "2008"
      },
      {
        "nctId": "NCT00720122",
        "title": "Effects of rhIGF-1 on Bone Metabolism in Adolescent Girls With Anorexia Nervosa",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": "2008"
      },
      {
        "nctId": "NCT00903110",
        "title": "Global Patient Registry to Monitor Long-term Safety and Effectiveness of Increlex® in Children and Adolescents With Severe Primary Insulin-like Growth Factor-1 Deficiency (SPIGFD).",
        "status": "RECRUITING",
        "phase": "",
        "startYear": "2008"
      },
      {
        "nctId": "NCT00915954",
        "title": "Growth Hormone Feedback to Insulin-like Growth Factor-I (IGF-1) and Oral Glucose Tolerance Test (OGTT)",
        "status": "COMPLETED",
        "phase": "NA",
        "startYear": "2008"
      },
      {
        "nctId": "NCT00566241",
        "title": "IGF-1 Therapy in Patients With Cystic Fibrosis",
        "status": "TERMINATED",
        "phase": "PHASE1",
        "startYear": "2008"
      },
      {
        "nctId": "NCT00516386",
        "title": "Safety Profile of Insulin Like Growth Factor-1 (IGF-I) Administration in Adolescents",
        "status": "COMPLETED",
        "phase": "PHASE1/PHASE2",
        "startYear": "2007"
      },
      {
        "nctId": "NCT00572156",
        "title": "rhGH and rhIGF-1 Combination Therapy in Children With Short Stature Associated With IGF-1 Deficiency",
        "status": "TERMINATED",
        "phase": "PHASE2",
        "startYear": "2007"
      },
      {
        "nctId": "NCT00490100",
        "title": "Treatment for Growth Failure in Patients With X-Linked Severe Combined Immunodeficiency: Phase 2 Study of Insulin-Like Growth Factor-1",
        "status": "TERMINATED",
        "phase": "PHASE1/PHASE2",
        "startYear": "2007"
      },
      {
        "nctId": "NCT00747604",
        "title": "IGFD Registry: A Patient Registry for Monitoring Long-term Safety and Efficacy of Increlex",
        "status": "TERMINATED",
        "phase": "",
        "startYear": "2006"
      },
      {
        "nctId": "NCT00330668",
        "title": "Treatment of Children and Adolescents With Growth Failure Associated With Primary IGF-1 Deficiency",
        "status": "TERMINATED",
        "phase": "PHASE3",
        "startYear": "2005"
      },
      {
        "nctId": "NCT00125190",
        "title": "Recombinant Human Insulin-Like Growth Factor (rhIGF-1) Treatment of Short Stature Associated With IGF-1 Deficiency",
        "status": "COMPLETED",
        "phase": "PHASE2/PHASE3",
        "startYear": "2005"
      },
      {
        "nctId": "NCT00125164",
        "title": "Prepubertal Children With Growth Failure Associated With Primary Insulin-Like Growth Factor-1 (IGF-1) Deficiency",
        "status": "COMPLETED",
        "phase": "PHASE3",
        "startYear": "2004"
      },
      {
        "nctId": "NCT00035815",
        "title": "Insulin-like Growth Factor-1 in Amyotrophic Lateral Sclerosis (ALS) Trial",
        "status": "COMPLETED",
        "phase": "PHASE3",
        "startYear": "2003"
      },
      {
        "nctId": "NCT00001669",
        "title": "A 48-Week (24-Week Baseline Followed by a 24-Week Treatment) Phase II Pilot Study of the Tolerability and Effect/Efficacy of Subcutaneously Administered Insulin-Like Growth Factor-1 (rhIGF) (CEP-151) in Multiple Sclerosis (MS) Patients",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": "1997"
      },
      {
        "nctId": "NCT00004815",
        "title": "Descriptive Study of Recombinant Human Insulin-Like Growth Factor for Osteoporosis in Werner's Syndrome",
        "status": "COMPLETED",
        "phase": "NA",
        "startYear": "1992"
      },
      {
        "nctId": "NCT00571727",
        "title": "Long-Term Treatment With rhIGF-1 in GHIS",
        "status": "COMPLETED",
        "phase": "PHASE2/PHASE3",
        "startYear": "1991"
      }
    ],
    "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"
      ]
    }
  }
}