{"id":"daprodustat-tablets","safety":{"commonSideEffects":[{"rate":null,"effect":"Hypertension"},{"rate":null,"effect":"Hyperkalemia"},{"rate":null,"effect":"Thrombotic events"},{"rate":null,"effect":"Headache"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"By inhibiting prolyl hydroxylase enzymes that regulate hypoxia-inducible factor (HIF) stability, daprodustat allows HIF to accumulate and activate erythropoietin (EPO) gene expression. This mimics the body's natural hypoxic response, increasing red blood cell production without requiring exogenous EPO administration. The mechanism is particularly useful in chronic kidney disease where EPO production is impaired.","oneSentence":"Daprodustat is a hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor that stimulates endogenous erythropoietin production to treat anemia.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:08:40.116Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Anemia in chronic kidney disease (CKD) patients on dialysis"},{"name":"Anemia in chronic kidney disease patients not on dialysis"}]},"trialDetails":[{"nctId":"NCT04640311","phase":"PHASE1","title":"Comparison of Daprodustat Formulations Produced by Two Methods of Manufacture for Bioequivalence and Dissolution in Healthy Participants","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2020-12-18","conditions":"Anaemia","enrollment":259},{"nctId":"NCT05951192","phase":"PHASE4","title":"A Prospective Interventional Study Assessing the Clinical and Operational 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Study","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2018-04-24","conditions":"Anaemia","enrollment":64},{"nctId":"NCT02689206","phase":"PHASE2","title":"Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Three-times Weekly Dosing of GSK1278863 in Hemodialysis-dependent Subjects With Anemia Associated With Chronic Kidney Disease Who Are Switched From a Stable Dose of an Erythropoiesis-stimulating Agent","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2016-02-17","conditions":"Anaemia","enrollment":103},{"nctId":"NCT03239522","phase":"PHASE1","title":"Absorption and Elimination of Radiolabeled Daprodustat","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2017-10-10","conditions":"Anaemia","enrollment":6},{"nctId":"NCT02829320","phase":"PHASE3","title":"Efficacy and Safety Study of GSK1278863 in Japanese Hemodialysis Subjects With Anemia Associated With Chronic Kidney Disease Who Are Not Taking Erythropoiesis Stimulating Agents","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2016-08-08","conditions":"Anaemia","enrollment":28},{"nctId":"NCT03223337","phase":"PHASE1","title":"Daprodustat Hepatic Impairment Study","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2017-07-24","conditions":"Anaemia","enrollment":37},{"nctId":"NCT02243306","phase":"PHASE1","title":"Study to Assess the Pharmacokinetics of GSK1278863 in Subjects With End Stage Renal Disease Undergoing Peritoneal Dialysis","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2014-10-24","conditions":"Anaemia","enrollment":8},{"nctId":"NCT01977573","phase":"PHASE2","title":"A Study to Evaluate Safety and Efficacy of GSK1278863 in Non-Dialysis Dependent (NDD) Subjects With Anemia Associated With Chronic Kidney Diseases (CKD)","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2013-10-31","conditions":"Anaemia","enrollment":252},{"nctId":"NCT02293148","phase":"PHASE1","title":"Single Dose, 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Effects on Eccentric Exercise-Induced Muscle Damage","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2015-01-15","conditions":"Tendon Injuries","enrollment":26}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":2,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Daprodustat tablets","genericName":"Daprodustat tablets","companyName":"GlaxoSmithKline","companyId":"glaxosmithkline","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Daprodustat is a hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor that stimulates endogenous 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Used for Anemia in chronic kidney disease (CKD) patients on dialysis, Anemia in chronic kidney disease patients not on dialysis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}