{"id":"daprodustat-gsk1278863","safety":{"commonSideEffects":[{"rate":null,"effect":"Hypertension"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Thrombotic events"}]},"_chembl":{"chemblId":"CHEMBL3544988","moleculeType":"Small molecule","molecularWeight":"393.44"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"By inhibiting prolyl hydroxylase domain-containing proteins (PHD enzymes), daprodustat prevents the degradation of hypoxia-inducible factor (HIF), allowing HIF to accumulate and activate genes involved in erythropoiesis. This leads to increased endogenous erythropoietin (EPO) production and improved red blood cell formation, addressing anemia without requiring exogenous EPO administration. The mechanism mimics the body's natural hypoxic response to low oxygen levels.","oneSentence":"Daprodustat inhibits hypoxia-inducible factor prolyl hydroxylase (HIF-PH), stabilizing HIF and increasing endogenous erythropoietin production to treat anemia.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:08:33.020Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Anemia of chronic kidney disease"},{"name":"Anemia in patients with chronic kidney disease not on dialysis"}]},"trialDetails":[{"nctId":"NCT07346547","phase":"","title":"REDCURE Registry for Chronic Kidney Disease (CKD) Anemia","status":"NOT_YET_RECRUITING","sponsor":"Nabiqasim Industries (Pvt) Ltd","startDate":"2026-01-30","conditions":"CKD Anemia","enrollment":384},{"nctId":"NCT07300111","phase":"PHASE3","title":"A Study to Evaluate Efficacy and Safety of QLG1218(Daprodustat) in Chinese Hemodialysis (HD)-Dependent Subjects With Anemia Associated With Chronic Kidney Disease (CKD)","status":"NOT_YET_RECRUITING","sponsor":"Qilu Pharmaceutical Co., Ltd.","startDate":"2025-12-31","conditions":"Anaemia","enrollment":100},{"nctId":"NCT05682326","phase":"PHASE3","title":"Anemia Studies in CKD: Erythropoiesis Via a Novel PHI Daprodustat - Pediatric (ASCEND-P)","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2023-09-06","conditions":"Anaemia","enrollment":4},{"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 Effectiveness of Transitioning From Mircera to Daprodustat for the Treatment of Anemia in End Stage Kidney Disease","status":"COMPLETED","sponsor":"USRC Kidney Research","startDate":"2023-07-01","conditions":"Anemia, Renal Insufficiency, Chronic, Renal Anemia","enrollment":161},{"nctId":"NCT03409107","phase":"PHASE3","title":"Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat in Non-Dialysis Subjects Evaluating Hemoglobin (Hgb) and Quality of Life (ASCEND-NHQ)","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2018-03-05","conditions":"Anaemia","enrollment":614},{"nctId":"NCT02876835","phase":"PHASE3","title":"Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Non-Dialysis (ASCEND-ND)","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2016-09-27","conditions":"Anaemia","enrollment":3872},{"nctId":"NCT03446612","phase":"PHASE2","title":"Anemia Study in Chronic Kidney Disease (CKD) : Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat -Forearm Blood Flow (ASCEND-FBF)","status":"TERMINATED","sponsor":"GlaxoSmithKline","startDate":"2019-01-10","conditions":"Anaemia","enrollment":6},{"nctId":"NCT03457701","phase":"PHASE2","title":"Anemia Studies in CKD: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat- Iron (ASCEND: Fe)","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2019-07-30","conditions":"Anaemia","enrollment":15},{"nctId":"NCT02879305","phase":"PHASE3","title":"Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Dialysis (ASCEND-D)","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2016-09-28","conditions":"Anaemia, Aspergillosis, Allergic Bronchopulmonary","enrollment":2964},{"nctId":"NCT03029208","phase":"PHASE3","title":"Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-in Incident Dialysis (ASCEND-ID)","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2017-05-11","conditions":"Anaemia","enrollment":312},{"nctId":"NCT03400033","phase":"PHASE3","title":"Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-Three-times Weekly Dosing in Dialysis (ASCEND-TD)","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2018-09-05","conditions":"Anaemia","enrollment":407},{"nctId":"NCT03029247","phase":"PHASE2","title":"Anemia Study in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-Blood Pressure (ASCEND-BP)","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2017-07-27","conditions":"Anaemia","enrollment":105},{"nctId":"NCT02791763","phase":"PHASE3","title":"Phase III Study of GSK1278863 in Japanese Non-dialysis (ND) and Peritoneal Dialysis (PD) Subjects With Renal 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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":"NCT01831804","phase":"PHASE1","title":"Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of 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Used for Anemia of chronic kidney disease, Anemia in patients with chronic kidney disease not on dialysis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}