{"id":"albiglutide","rwe":[],"tags":[{"label":"GLP-1 Receptor Agonist","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Glucagon-like peptide 1 receptor","category":"target"},{"label":"GLP1R","category":"gene"},{"label":"A10BJ04","category":"atc"},{"label":"Active","category":"status"},{"label":"Diabetes mellitus type 2","category":"indication"},{"label":"Glaxosmithkline Llc","category":"company"},{"label":"Approved 2010s","category":"decade"}],"phase":"marketed","safety":{"safetySignals":[{"llr":521.375,"date":"","count":86,"signal":"Device use error","source":"DrugCentral FAERS","actionTaken":"Reported 86 times (LLR=521)"},{"llr":76.695,"date":"","count":19,"signal":"Device leakage","source":"DrugCentral FAERS","actionTaken":"Reported 19 times (LLR=77)"},{"llr":69.183,"date":"","count":22,"signal":"Accidental exposure to product","source":"DrugCentral FAERS","actionTaken":"Reported 22 times (LLR=69)"},{"llr":66.549,"date":"","count":16,"signal":"Product preparation error","source":"DrugCentral FAERS","actionTaken":"Reported 16 times (LLR=67)"}],"commonSideEffects":[],"contraindications":["History of medullary carcinoma of thyroid","Medullary thyroid carcinoma","Multiple endocrine neoplasia, type 2"]},"trials":[],"aliases":[],"company":"GSK","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=ALBIGLUTIDE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:46:58.073728+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Albiglutide","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T03:47:04.739904+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:47:03.347653+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ALBIGLUTIDE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:47:03.684875+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Glucagon-like peptide 1 receptor agonist","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:47:04.739846+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL2107841/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:47:04.391867+00:00"}},"allNames":"albugon","offLabel":[],"synonyms":["albiglutide","tanzeum","GSK-716155","GSK716155","albugon"],"timeline":[{"date":"2014-04-15","type":"positive","source":"DrugCentral","milestone":"FDA approval (Glaxosmithkline Llc)"}],"aiSummary":"Albugon (Albiglutide) is a GLP-1 Receptor Agonist, a small molecule developed by GlaxoSmithKline LLC, targeting the glucagon-like peptide 1 receptor. It was FDA-approved in 2014 for the treatment of diabetes mellitus type 2. Albugon works by mimicking the action of the natural hormone GLP-1, which helps regulate blood sugar levels. As a patented medication, its commercial status is subject to ongoing patent protection. Key safety considerations include potential gastrointestinal side effects and increased risk of pancreatitis.","brandName":"Albugon","ecosystem":[{"indication":"Diabetes mellitus type 2","otherDrugs":[{"name":"acarbose","slug":"acarbose","company":"Bayer Hlthcare"},{"name":"acetohexamide","slug":"acetohexamide","company":"Lilly"},{"name":"alogliptin","slug":"alogliptin","company":"Takeda Pharms Usa"},{"name":"bexagliflozin","slug":"bexagliflozin","company":"Theracosbio Llc"}],"globalPrevalence":537000000}],"mechanism":{"target":"Glucagon-like peptide 1 receptor","novelty":"Follow-on","targets":[{"gene":"GLP1R","source":"DrugCentral","target":"Glucagon-like peptide 1 receptor","protein":"Glucagon-like peptide 1 receptor"}],"moaClass":"Glucagon-like Peptide-1 (GLP-1) Agonists","modality":"Peptide","drugClass":"GLP-1 Receptor Agonist","explanation":"","oneSentence":"","technicalDetail":"Albugon binds to the extracellular domain of the GLP-1 receptor, triggering a conformational change that activates the receptor and initiates a signaling cascade that ultimately leads to increased insulin secretion and decreased glucagon secretion."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Albiglutide","title":"Albiglutide","extract":"Albiglutide is a glucagon-like peptide-1 agonist drug marketed by GlaxoSmithKline (GSK) for treatment of type 2 diabetes. In 2017 GSK announced Albiglutide's withdrawal from the worldwide market for economic reasons, and remaining stocks in the supply chain were effectively depleted by 2018.","wiki_history":"==History==\nThe drug was invented by Human Genome Sciences (HGSI) and was developed in collaboration with GSK, which later bought HGSI outright.\n\nGSK filed for US FDA approval on 14 January 2013 and for European Medicines Agency (EMA) approval on 7 March 2013. In March 2014, GSK received approval from the European Commission to market albiglutide under the name Eperzan.\nIn April 2014, the US FDA approved albiglutide under the name Tanzeum.\n\nIn August 2017, GSK announced that it intended to withdraw the drug from the worldwide market by July 2018 for economic reasons."},"commercial":{"launchDate":"2014","_launchSource":"DrugCentral (FDA 2014-04-15, GLAXOSMITHKLINE LLC)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4927","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=ALBIGLUTIDE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ALBIGLUTIDE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Albiglutide","fields":["history","overview"],"source":"Wikipedia"}],"_enrichedAt":"2026-03-30T08:33:36.448410","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:47:05.975808+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"exenatide","drugSlug":"exenatide","fdaApproval":"2005-04-28","patentExpiry":"Sep 21, 2028","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"liraglutide","drugSlug":"liraglutide","fdaApproval":"2010-01-25","patentExpiry":"Jul 9, 2037","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"lixisenatide","drugSlug":"lixisenatide","fdaApproval":"2016-07-27","relationship":"same-class"},{"drugName":"dulaglutide","drugSlug":"dulaglutide","fdaApproval":"2014-09-18","relationship":"same-class"},{"drugName":"semaglutide","drugSlug":"semaglutide","fdaApproval":"2017-12-05","patentExpiry":"Sep 29, 2027","patentStatus":"Patent protected","relationship":"same-class"}],"genericName":"albiglutide","indications":{"approved":[{"name":"Diabetes mellitus type 2","source":"DrugCentral","snomedId":44054006,"regulator":"FDA","usPrevalence":37300000,"globalPrevalence":537000000,"prevalenceMethod":"curated","prevalenceSource":"IDF Diabetes Atlas, 2024"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"exenatide","brandName":"exenatide","genericName":"exenatide","approvalYear":"2005","relationship":"same-class"},{"drugId":"liraglutide","brandName":"liraglutide","genericName":"liraglutide","approvalYear":"2010","relationship":"same-class"},{"drugId":"lixisenatide","brandName":"lixisenatide","genericName":"lixisenatide","approvalYear":"2016","relationship":"same-class"},{"drugId":"dulaglutide","brandName":"dulaglutide","genericName":"dulaglutide","approvalYear":"2014","relationship":"same-class"},{"drugId":"semaglutide","brandName":"semaglutide","genericName":"semaglutide","approvalYear":"2017","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT05220917","phase":"","title":"Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study","status":"ACTIVE_NOT_RECRUITING","sponsor":"Brigham and Women's Hospital","startDate":"2021-08-01","conditions":["Cardiovascular Events","Type2 Diabetes","Renal Disease"],"enrollment":781430,"completionDate":"2026-07-01"},{"nctId":"NCT07188545","phase":"","title":"Using Secondary Data to Evaluate Sex-based Heterogeneity of GLP-1 Agonists and SGLT2 Inhibitors on Cardiovascular-Kidney-Metabolic Health (CKMH) Outcomes in Real-world Settings (DASH-CKMH)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Ohio State University","startDate":"2025-09-15","conditions":["Cardiovascular Kidney Metabolic Syndrome"],"enrollment":23280000,"completionDate":"2029-06-30"},{"nctId":"NCT03492580","phase":"","title":"A Study for Comparison of Canagliflozin Versus Alternative Antihyperglycemic Treatments on Risk of Heart Failure Hospitalization and Amputation for Participants With Type 2 Diabetes Mellitus and the Subpopulation With Established Cardiovascular Disease","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2018-02-22","conditions":["Diabetes Mellitus, Type 2","Cardiovascular Diseases"],"enrollment":714582,"completionDate":"2018-06-25"},{"nctId":"NCT06449235","phase":"PHASE4","title":"Real-World Evaluation of Omarigliptin for Type 2 Diabetes Meliitus in Bangladesh","status":"NOT_YET_RECRUITING","sponsor":"Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders","startDate":"2024-09","conditions":["Type2diabetes"],"enrollment":938,"completionDate":"2025-06"},{"nctId":"NCT02787551","phase":"PHASE3","title":"Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) Versus GLP-1 Receptor Agonist in Patients With Type 2 Diabetes, With a FRC Extension Period","status":"COMPLETED","sponsor":"Sanofi","startDate":"2016-07-06","conditions":["Type 2 Diabetes Mellitus"],"enrollment":514,"completionDate":"2018-11-17"},{"nctId":"NCT02229227","phase":"PHASE3","title":"Safety and Efficacy of Albiglutide + Insulin Glargine Versus Insulin Lispro + Insulin Glargine Subjects With Type 2 Diabetes Mellitus","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2014-11-21","conditions":["Diabetes Mellitus, Type 2"],"enrollment":814,"completionDate":"2017-07-24"},{"nctId":"NCT02846233","phase":"NA","title":"Stepping-down Approach in Patients With Chronic Poorly-controlled Diabetes on Advanced Insulin Therapy?","status":"COMPLETED","sponsor":"University of California, San Francisco","startDate":"2016-08","conditions":["Type 2 Diabetes Mellitus"],"enrollment":22,"completionDate":"2018-12"},{"nctId":"NCT02802514","phase":"PHASE4","title":"A Study Comparing the Effect of Albiglutide With Exenatide on Regional Brain Activity Related to Nausea in Healthy Subjects","status":"TERMINATED","sponsor":"GlaxoSmithKline","startDate":"2016-09-20","conditions":["Diabetes Mellitus"],"enrollment":5,"completionDate":"2017-09-07"},{"nctId":"NCT02793154","phase":"PHASE4","title":"An Exploratory Study on the Effects of Repeat Doses of Albiglutide Compared to Exenatide on Gastric Myoelectrical Activity and Gastric Emptying in Type 2 Diabetes Mellitus Subjects","status":"TERMINATED","sponsor":"GlaxoSmithKline","startDate":"2016-09-26","conditions":["Diabetes Mellitus, Type 2"],"enrollment":4,"completionDate":"2017-03-16"},{"nctId":"NCT02284009","phase":"PHASE2","title":"Albiglutide Versus Placebo in Insulin-treated Subjects With New-onset Type 1 Diabetes Mellitus","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2014-10-10","conditions":["Diabetes Mellitus, Type 1"],"enrollment":67,"completionDate":"2017-10-18"},{"nctId":"NCT02683746","phase":"PHASE3","title":"Safety and Efficacy Study of Albiglutide Liquid Drug Product in Type 2 Diabetes Mellitus","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2016-03-16","conditions":["Diabetes Mellitus, Type 2"],"enrollment":308,"completionDate":"2017-05-15"},{"nctId":"NCT02750930","phase":"PHASE4","title":"Extension to Study 200952 to Evaluate the Long-term Safety, Tolerability and Pharmacodynamics of Albiglutide Liquid Drug Product in Type 2 Diabetes Mellitus Subjects","status":"TERMINATED","sponsor":"GlaxoSmithKline","startDate":"2016-10-07","conditions":["Diabetes Mellitus, Type 2"],"enrollment":8,"completionDate":"2017-03-21"},{"nctId":"NCT02465515","phase":"PHASE4","title":"Effect of Albiglutide, When Added to Standard Blood Glucose Lowering Therapies, on Major Cardiovascular Events in Subjects With Type 2 Diabetes Mellitus","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2015-07-01","conditions":["Diabetes Mellitus"],"enrollment":9463,"completionDate":"2018-03-14"},{"nctId":"NCT03015519","phase":"PHASE3","title":"A Study to Evaluate Pharmacokinetics, Safety and Efficacy of Albiglutide in Pediatric Subjects With Type 2 Diabetes Mellitus","status":"WITHDRAWN","sponsor":"GlaxoSmithKline","startDate":"2017-08-14","conditions":["Diabetes Mellitus, Type 2"],"enrollment":0,"completionDate":"2020-04-20"},{"nctId":"NCT02496221","phase":"PHASE4","title":"A Study Evaluating the Effect of Albiglutide on Gallbladder Emptying in Healthy Subjects","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2015-06-11","conditions":["Diabetes Mellitus, Type 2"],"enrollment":20,"completionDate":"2015-10-13"},{"nctId":"NCT00537719","phase":"PHASE1","title":"Scintigraphy Study to Assess Gastric Emptying in Healthy Subjects Given GSK716155 or Placebo.","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2007-12-07","conditions":["Diabetes Mellitus, Type 2"],"enrollment":34,"completionDate":"2008-04-04"},{"nctId":"NCT00938158","phase":"PHASE1","title":"A Study of the Pharmacokinetics of Albiglutide in Normal and Renally Impaired Subjects.","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2009-08-05","conditions":["Diabetes Mellitus, Type 2"],"enrollment":75,"completionDate":"2011-04-12"},{"nctId":"NCT01147731","phase":"PHASE1","title":"A Drug Interaction Study With Albiglutide and Warfarin","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2010-06-04","conditions":["Diabetes Mellitus, Type 2"],"enrollment":16,"completionDate":"2010-09-09"},{"nctId":"NCT01077505","phase":"PHASE1","title":"An Evaluation of the Pharmacokinetics of an Oral Contraceptive (Brevicon) When Co-administered With Albiglutide .","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2010-03-15","conditions":["Diabetes Mellitus, Type 2"],"enrollment":16,"completionDate":"2010-11-24"},{"nctId":"NCT01147718","phase":"PHASE1","title":"A Drug Interaction Study of Albiglutide and Digoxin","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2010-06-11","conditions":["Diabetes Mellitus, Type 2"],"enrollment":30,"completionDate":"2010-11-29"},{"nctId":"NCT01406262","phase":"PHASE1","title":"Albiglutide Thorough ECG Study in Healthy Volunteers","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2011-07-06","conditions":["Diabetes Mellitus, Type 2"],"enrollment":94,"completionDate":"2011-12-29"},{"nctId":"NCT01147692","phase":"PHASE1","title":"A Drug Interaction Study of Simvastatin and Albiglutide","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2010-05-19","conditions":["Diabetes Mellitus, Type 2"],"enrollment":40,"completionDate":"2010-08-27"},{"nctId":"NCT01777282","phase":"PHASE3","title":"A Study to Determine the Long Term Safety and Efficacy of Albiglutide in Combination With Oral Monotherapy Antihyperglycemic Medications in Japanese Patients With Type 2 Diabetes Mellitus","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2013-02-23","conditions":["Diabetes Mellitus"],"enrollment":374,"completionDate":"2015-01-27"},{"nctId":"NCT01098539","phase":"PHASE3","title":"A Study of the Efficacy and Safety of Albiglutide in Subjects With Type 2 Diabetes With Renal Impairment.","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2010-05","conditions":["Diabetes Mellitus, Type 2"],"enrollment":507,"completionDate":"2012-11"},{"nctId":"NCT01128894","phase":"PHASE3","title":"A Study to Determine the Efficacy and Safety of Albiglutide as Compared With Liraglutide.","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2010-05","conditions":["Diabetes Mellitus, Type 2"],"enrollment":841,"completionDate":"2011-09"},{"nctId":"NCT01098461","phase":"PHASE2","title":"Dose Ranging Study of Albiglutide in Japanese Subjects","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2010-04","conditions":["Diabetes Mellitus, Type 2"],"enrollment":215,"completionDate":"2011-05"},{"nctId":"NCT00976391","phase":"PHASE3","title":"A Study to Determine the Safety and Efficacy of Albiglutide Administered in Combination With Insulin Glargine","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2009-09","conditions":["Diabetes Mellitus, Type 2"],"enrollment":586,"completionDate":"2012-05"},{"nctId":"NCT01475734","phase":"PHASE2","title":"Albiglutide Glucose Clamp Study in Subjects With Type 2 Diabetes","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2011-12","conditions":["Diabetes Mellitus, Type 2"],"enrollment":44,"completionDate":"2012-07"},{"nctId":"NCT01357889","phase":"PHASE2","title":"Pharmacokinetics/Pharmacodynamics of Albiglutide","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2011-07","conditions":["Diabetes Mellitus, Type 2"],"enrollment":283,"completionDate":"2012-10"},{"nctId":"NCT00838916","phase":"PHASE3","title":"A Study to Determine the Safety and Efficacy of Albiglutide in Patients With Type 2 Diabetes","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2009-02","conditions":["Diabetes Mellitus, Type 2"],"enrollment":779,"completionDate":"2013-05"},{"nctId":"NCT00838903","phase":"PHASE3","title":"Efficacy and Safety of Albiglutide in Treatment of Type 2 Diabetes","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2009-02","conditions":["Diabetes Mellitus, Type 2"],"enrollment":1049,"completionDate":"2013-04"},{"nctId":"NCT00849017","phase":"PHASE3","title":"Safety and Efficacy Study of Albiglutide in Type 2 Diabetes","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2009-01","conditions":["Diabetes Mellitus, Type 2"],"enrollment":309,"completionDate":"2013-02"},{"nctId":"NCT00849056","phase":"PHASE3","title":"Safety and Efficacy of Albiglutide in Type 2 Diabetes","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2009-01","conditions":["Diabetes Mellitus, Type 2"],"enrollment":310,"completionDate":"2013-01"},{"nctId":"NCT00839527","phase":"PHASE3","title":"A Study to Determine the Safety and Efficacy of Albiglutide in Subjects With Type 2 Diabetes","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2009-02","conditions":["Diabetes Mellitus, Type 2"],"enrollment":685,"completionDate":"2013-04"},{"nctId":"NCT00518115","phase":"PHASE2","title":"Out-Patient Study in Patients With Type 2 Diabetes Mellitus Who Are Taking no Diabetes Medication or Metformin Only","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2007-04","conditions":["Diabetes Mellitus, Type 2"],"enrollment":361,"completionDate":"2008-05"},{"nctId":"NCT02660736","phase":"PHASE1","title":"Bioequivalence Study of Two Albiglutide Drug Products in Healthy Adult Subjects","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2016-02","conditions":["Diabetes Mellitus, Type 2"],"enrollment":59,"completionDate":"2016-08"},{"nctId":"NCT00354536","phase":"PHASE2","title":"In-patient Study With GSK716155 In Patients With Type 2 Diabetes Mellitus","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2006-02","conditions":["Diabetes Mellitus, Type 2"],"enrollment":60,"completionDate":"2006-09"},{"nctId":"NCT01733758","phase":"PHASE3","title":"A Monotherapy Study to Evaluate the Efficacy and Safety of 2 Dose Levels of Albiglutide in Japanese Subjects With Type 2 Diabetes Mellitus (T2DM)","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2013-02","conditions":["Diabetes Mellitus, Type 2"],"enrollment":494,"completionDate":"2015-02"},{"nctId":"NCT02229240","phase":"PHASE3","title":"Albiglutide Versus Placebo Added-on to Basal-Bolus Insulin Therapy in Subjects With Type 2 Diabetes Mellitus","status":"WITHDRAWN","sponsor":"GlaxoSmithKline","startDate":"2015-08","conditions":["Diabetes Mellitus, Type 2"],"enrollment":0,"completionDate":"2015-12"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"crossReferences":{"NUI":"N0000190764","MMSL":"216723","NDDF":"015507","UNII":"5E7U48495E","VUID":"4033416","CHEBI":"CHEBI:78425","VANDF":"4033416","INN_ID":"8829","RXNORM":"1534763","UMLSCUI":"C2607479","chemblId":"CHEMBL2107841","ChEMBL_ID":"CHEMBL2107841","KEGG_DRUG":"D08843","DRUGBANK_ID":"DB09043","PUBCHEM_CID":"145994868","SNOMEDCT_US":"703129009","IUPHAR_LIGAND_ID":"7386","MESH_SUPPLEMENTAL_RECORD_UI":"C534611"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[{"period":"2014-","companyName":"GSK","relationship":"Original Developer"}],"publicationCount":275,"therapeuticAreas":["Metabolic"],"atcClassification":{"source":"DrugCentral","atcCode":"A10BJ04","allCodes":["A10BJ04"]},"biosimilarFilings":[],"originalDeveloper":"Glaxosmithkline Llc","recentPublications":[],"companionDiagnostics":[],"genericManufacturerList":[],"status":"approved","companyName":"GSK","companyId":"gsk","modality":"Recombinant protein","firstApprovalDate":"2014","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"EU","regulator":"EMA","status":"withdrawn","approval_date":null,"mah":null,"brand_name_local":"Eperzan","application_number":"EMEA/H/C/002735"},{"country_code":"GB","regulator":"MHRA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Eperzan","application_number":null},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:47:05.975808+00:00","fieldsConflicting":2,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}