{"id":"somatropin-adult-cohort","rwe":[],"tags":[],"safety":{"drugInteractions":[{"drug":"Insulin","action":"Monitor","effect":"Hypoglycemia"},{"drug":"Oral anticoagulants","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Estrogen-containing products","action":"Avoid","effect":"Increased risk of thromboembolic events"},{"drug":"Immunosuppressants","action":"Monitor","effect":"Increased risk of infections"},{"drug":"Thyroid hormones","action":"Monitor","effect":"Increased risk of hypothyroidism"},{"drug":"Corticosteroids","action":"Monitor","effect":"Increased risk of hypoadrenalism"},{"drug":"Warfarin","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Anticonvulsants","action":"Monitor","effect":"Increased risk of hypoglycemia"},{"drug":"Beta-blockers","action":"Monitor","effect":"Increased risk of hypoglycemia"},{"drug":"Salicylates","action":"Monitor","effect":"Increased risk of hypoglycemia"},{"drug":"Thiazide diuretics","action":"Monitor","effect":"Increased risk of hypokalemia"},{"drug":"ACE inhibitors","action":"Monitor","effect":"Increased risk of hypotension"},{"drug":"Angiotensin II receptor blockers","action":"Monitor","effect":"Increased risk of hypotension"},{"drug":"Nonsteroidal anti-inflammatory drugs (NSAIDs)","action":"Monitor","effect":"Increased risk of hypoglycemia"},{"drug":"Sulfonylureas","action":"Monitor","effect":"Increased risk of hypoglycemia"},{"drug":"Glucagon-like peptide-1 (GLP-1) receptor agonists","action":"Monitor","effect":"Increased risk of hypoglycemia"},{"drug":"Dipeptidyl peptidase-4 (DPP-4) inhibitors","action":"Monitor","effect":"Increased risk of hypoglycemia"},{"drug":"SGLT2 inhibitors","action":"Monitor","effect":"Increased risk of hypoglycemia"},{"drug":"Biguanides","action":"Monitor","effect":"Increased risk of hypoglycemia"},{"drug":"Meglitinides","action":"Monitor","effect":"Increased risk of hypoglycemia"},{"drug":"Alpha-glucosidase inhibitors","action":"Monitor","effect":"Increased risk of hypoglycemia"},{"drug":"Thiazolidinediones","action":"Monitor","effect":"Increased risk of hypoglycemia"},{"drug":"Bromocriptine","action":"Monitor","effect":"Increased risk of hypoglycemia"},{"drug":"Pramlintide","action":"Monitor","effect":"Increased risk of hypoglycemia"}],"contraindications":["Hypersensitivity to somatropin or any of the excipients, active malignancy, closed epiphyses, Prader-Willi syndrome with severe obesity or respiratory impairment, patients with acute critical illness due to complications following open heart surgery, abdominal surgery, multiple accidental trauma, or those with acute respiratory failure."]},"trials":[],"_chembl":null,"aliases":[],"company":"Pfizer","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=somatropin-adult-cohort","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:56:54.454924+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:57:00.086674+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-19T23:56:54.528742+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=somatropin-adult-cohort","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:57:00.452201+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Growth hormone receptor agonist","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:57:01.537640+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1201621/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:57:01.201011+00:00"}},"allNames":"somatropin - adult cohort","offLabel":[],"timeline":[],"_dailymed":null,"brandName":"somatropin - adult cohort","ecosystem":[],"isGeneric":true,"mechanism":{"target":"Growth Hormone Receptor","novelty":"Best-in-class","modality":"Biological","drugClass":"Growth Hormone","explanation":"","oneSentence":"","technicalDetail":"Somatropin is a recombinant human growth hormone analogue that mimics the action of the body's natural growth hormone. It stimulates the production of insulin-like growth factor-1 (IGF-1), which promotes growth and development. Somatropin is administered via injection and is available in various forms."},"_companyIR":{"url":"https://www.pfizer.com/investors","revenueRefs":[],"pipelineRefs":[]},"_scrapedAt":"2026-03-27T23:28:43.649Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"commercial":{"revenueYear":2025,"annualCostUS":"Generic pricing varies by manufacturer","annualRevenue":446,"genericStatus":"Biologic — patent protected","revenueSource":"SEC 8-K Pfizer (2026-02-03)","revenueCurrency":"USD","peakSalesEstimate":"Not publicly reported","revenueConfidence":"verified (SEC filing)","revenueExtractedAt":"2026-04-01T11:46:12.481336","revenueExtractedBy":"revenue-sec"},"references":[{"id":1,"url":"https://clinicaltrials.gov/search?intr=somatropin-adult-cohort","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=somatropin-adult-cohort","fields":["publications"],"source":"PubMed/NCBI"},{"id":3,"url":"https://www.ebi.ac.uk/chembl/","fields":["molecular"],"source":"ChEMBL (EMBL-EBI)"},{"id":4,"url":"https://www.ema.europa.eu/","fields":["regulatoryStatus"],"source":"European Medicines Agency (EMA)"},{"id":5,"url":"https://list.essentialmeds.org/","fields":["regulatoryStatus"],"source":"WHO Essential Medicines List"}],"_tgaChecked":true,"_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-19T23:57:02.965428+00:00","fieldsConflicting":1,"overallConfidence":0.8},"_whoChecked":true,"biosimilars":[],"competitors":[{"name":"Norditropin","company":"Novo Nordisk","advantage":"Similar efficacy and longer shelf life","genericName":"somatropin"},{"name":"Humatrope","company":"Eli Lilly","advantage":"Wide range of dosages and formulations","genericName":"somatropin"},{"name":"Genotropin","company":"Pfizer","advantage":"Convenient pen device for easy administration","genericName":"somatropin"},{"name":"Saizen","company":"Merck","advantage":"Long-acting formulation for reduced frequency of injections","genericName":"somatropin"},{"name":"Zomacton","company":"Pfizer","advantage":"Convenient pen device for easy administration","genericName":"somatropin"}],"genericName":"somatropin-adult-cohort","indications":{"approved":[{"name":"Treatment of growth hormone deficiency in adults.","regulator":"FDA"},{"name":"Treatment of short bowel syndrome and failure to thrive in adults.","regulator":"FDA"},{"name":"Treatment of HIV-associated wasting in adults.","regulator":"FDA"},{"name":"Treatment of adult-onset growth hormone deficiency.","regulator":"FDA"},{"name":"Treatment of Turner syndrome in adults.","regulator":"FDA"},{"name":"Treatment of Prader-Willi syndrome in adults.","regulator":"FDA"},{"name":"Treatment of growth hormone deficiency in adults with a history of radiation therapy to the head.","regulator":"FDA"},{"name":"Treatment of growth hormone deficiency in adults with a history of pituitary surgery.","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"_mhraChecked":true,"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT04697381","phase":"PHASE3","title":"Study of the Efficacy and Safety of Somatropin in Japanese Participants With PWS","status":"COMPLETED","sponsor":"Pfizer","startDate":"2021-02-09","conditions":"Prader-Willi Syndrome","enrollment":33},{"nctId":"NCT02526420","phase":"PHASE2","title":"Versartis International Trial in Adults With Long-Acting Growth Hormone","status":"COMPLETED","sponsor":"Versartis Inc.","startDate":"2015-07","conditions":"Adult Growth Hormone Deficiency","enrollment":36},{"nctId":"NCT00444964","phase":"PHASE3","title":"Growth Hormone Use in Adults With Prader-Willi Syndrome","status":"COMPLETED","sponsor":"Children's Mercy Hospital Kansas City","startDate":"2005-04","conditions":"Prader-Willi Syndrome","enrollment":11},{"nctId":"NCT01196156","phase":"","title":"Follow-up to Adult Height of a Cohort of Subjects Born Small for the Gestational Age and Treated With Growth Hormone","status":"COMPLETED","sponsor":"Merck KGaA, Darmstadt, Germany","startDate":"2005-09-30","conditions":"Infant, Small for Gestational Age","enrollment":443},{"nctId":"NCT00960128","phase":"","title":"Observational Prospective Study on Patients Treated With Norditropin®","status":"COMPLETED","sponsor":"Novo Nordisk A/S","startDate":"2006-04-01","conditions":"Growth Hormone Disorder, Growth Hormone Deficiency in Children, Adult Growth Hormone Deficiency","enrollment":21249},{"nctId":"NCT01822340","phase":"PHASE2","title":"Safety and Efficacy Study of Recombinant Human Growth Hormone in Adult Growth Hormone Deficiency Patients","status":"COMPLETED","sponsor":"Hanmi Pharmaceutical Company Limited","startDate":"2011-10","conditions":"Adult Growth Hormone Deficiency","enrollment":72}],"_emaApprovals":[{"date":"","name":"somatropin - adult cohort","status":"Authorised","regulator":"EMA"}],"_faersSignals":[],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"molecularData":{"oral":false,"chemblId":"CHEMBL1201621","moleculeType":"Protein","molecularWeight":""},"_patentsChecked":true,"_warningLetters":[{"date":"03/28/2023","subject":"11/07/2022\tTodos Medical Ltd aka Todos Medical USA Inc\tCenter for Food Safety and Applied Nutrition"},{"date":"03/27/2026","subject":"Feedback form"}],"crossReferences":{"chemblId":"CHEMBL1201621"},"formularyStatus":[],"_approvalHistory":[],"_offLabelChecked":true,"developmentCodes":[],"ownershipHistory":[],"publicationCount":0,"therapeuticAreas":["Infectious Disease"],"_revenueScrapedAt":"2026-04-01 10:46:12.504516+00","biosimilarFilings":[],"recentPublications":[],"_drugWebsiteChecked":true,"_healthCanadaChecked":true,"companionDiagnostics":[],"_genericFilersChecked":true,"genericManufacturerList":[],"phase":"marketed","status":"approved","companyName":"Pfizer","companyId":"pfizer","modality":"Biological","firstApprovalDate":"","aiSummary":"","enrichmentLevel":3,"visitCount":3,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"EU","regulator":"EMA","status":"pending","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":1,"withResults":1},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-19T23:57:02.965428+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}