{"id":"molidustat-bay85-3934","safety":{"commonSideEffects":[{"rate":"10-20%","effect":"Hypertension"},{"rate":"5-15%","effect":"Gastrointestinal disorders"}]},"_chembl":{"chemblId":"CHEMBL3646118","moleculeType":"Small molecule","molecularWeight":"314.31"},"_dailymed":null,"mechanism":{"_ai_source":"featherless-qwen","explanation":"By inhibiting HIF-PH enzymes, molidustat prevents the degradation of HIF-α subunits, which then form complexes with HIF-β subunits. These complexes upregulate the expression of genes involved in erythropoiesis, including erythropoietin, thereby increasing red blood cell production.","oneSentence":"Molidustat activates hypoxia-inducible factor prolyl hydroxylase (HIF-PH) enzymes, leading to stabilization of HIF-α subunits and increased erythropoietin production.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:21:54.323Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Anemia associated with chronic kidney disease (CKD) in adults not on dialysis"},{"name":"Anemia associated with CKD in adults on dialysis"}]},"trialDetails":[{"nctId":"NCT04899661","phase":"","title":"A Study to Learn More About the Long-term Safety and Effectiveness of Molidustat as a Treatment for Japanese Men and Women With Renal Anemia","status":"ACTIVE_NOT_RECRUITING","sponsor":"Bayer","startDate":"2021-08-06","conditions":"Renal Anemia","enrollment":1081},{"nctId":"NCT03543657","phase":"PHASE3","title":"Maintenance Treatment of Renal Anemia in Dialysis Subjects","status":"COMPLETED","sponsor":"Bayer","startDate":"2018-06-23","conditions":"Anemia, Renal Insufficiency, Chronic","enrollment":229},{"nctId":"NCT03418168","phase":"PHASE3","title":"A Study of Molidustat for Treatment of Renal Anemia in Peritoneal Dialysis Subjects","status":"COMPLETED","sponsor":"Bayer","startDate":"2018-02-22","conditions":"Anemia, Renal Insufficiency, Chronic","enrollment":51},{"nctId":"NCT03351166","phase":"PHASE3","title":"A Study of Molidustat for Correction of Renal Anemia in Dialysis Subjects","status":"COMPLETED","sponsor":"Bayer","startDate":"2018-01-22","conditions":"Anemia, Renal Insufficiency, Chronic","enrollment":25},{"nctId":"NCT03350321","phase":"PHASE3","title":"A Study of Molidustat for Correction of Renal Anemia in Non-dialysis Subjects","status":"COMPLETED","sponsor":"Bayer","startDate":"2017-12-12","conditions":"Anemia, Renal Insufficiency, Chronic","enrollment":162},{"nctId":"NCT03350347","phase":"PHASE3","title":"A Study of Molidustat for Maintenance Treatment of Renal Anemia in Non-dialysis Subjects","status":"COMPLETED","sponsor":"Bayer","startDate":"2017-12-13","conditions":"Anemia, Renal Insufficiency, Chronic","enrollment":164},{"nctId":"NCT01318551","phase":"PHASE1","title":"Single Dose Group Stratified Study in Renal Impaired and Healthy Aged and Gender Matched Subjects","status":"COMPLETED","sponsor":"Bayer","startDate":"2011-03-16","conditions":"Anemia","enrollment":56},{"nctId":"NCT02312973","phase":"PHASE1","title":"To Investigate Pharmacokinetics (Absorption, Distribution, Elimination), Safety and Tolerability of a Single Oral Dose of 75 mg Molidustat Tablet in Male and Female Subjects Requiring Hemo- or Peritoneal Dialysis Compared to Healthy Subjects","status":"COMPLETED","sponsor":"Bayer","startDate":"2015-01-14","conditions":"Renal Insufficiency, Chronic","enrollment":40},{"nctId":"NCT01975818","phase":"PHASE2","title":"Maintenance Treatment of Anemia Associated With Chronic Kidney Disease (CKD) in Hemodialysis Subjects on Epoetin Alfa / Beta Treatment Versus BAY85-3934","status":"COMPLETED","sponsor":"Bayer","startDate":"2013-10-28","conditions":"Anemia, Renal Insufficiency, Chronic","enrollment":201},{"nctId":"NCT02064426","phase":"PHASE2","title":"Long Term Extension Study for the Maintenance Treatment of Anemia Associated With Chronic Kidney Disease (CKD) in Hemodialysis Subjects on Epoetin Alfa / Beta Treatment Versus BAY85-3934","status":"COMPLETED","sponsor":"Bayer","startDate":"2014-03-13","conditions":"Anemia, Renal Insufficiency, Chronic","enrollment":88},{"nctId":"NCT02021409","phase":"PHASE2","title":"Maintenance Treatment of Anemia in Pre-dialysis Subjects With Chronic Kidney Disease on Darbepoetin Treatment Versus BAY85-3934","status":"COMPLETED","sponsor":"Bayer","startDate":"2014-01-28","conditions":"Anemia, Renal Insufficiency, Chronic","enrollment":126},{"nctId":"NCT02055482","phase":"PHASE2","title":"Long-term Pre-dialysis Extension in Europe and Asia Pacific","status":"COMPLETED","sponsor":"Bayer","startDate":"2014-06-24","conditions":"Anemia, Renal Insufficiency, Chronic","enrollment":166},{"nctId":"NCT01679587","phase":"PHASE1","title":"Dose Escalation Study to Investigate Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of BAY85-3934 in Subjects With Chronic Kidney Disease (CKD)","status":"COMPLETED","sponsor":"Bayer","startDate":"2012-09","conditions":"Kidney Diseases","enrollment":49},{"nctId":"NCT01332942","phase":"PHASE1","title":"Combined Single / Multiple Dose Escalation Study in Patients With Renal Anemia Due to CKD (Chronic Kidney Disease)","status":"COMPLETED","sponsor":"Bayer","startDate":"2011-04","conditions":"Anemia","enrollment":44}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"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":"Molidustat (BAY85-3934)","genericName":"Molidustat (BAY85-3934)","companyName":"Bayer","companyId":"bayer","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Molidustat activates hypoxia-inducible factor prolyl hydroxylase (HIF-PH) enzymes, leading to stabilization of HIF-α subunits and increased erythropoietin production. Used for Anemia associated with chronic kidney disease (CKD) in adults not on dialysis, Anemia associated with CKD in adults on dialysis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}