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Molidustat (BAY85-3934)
Molidustat activates hypoxia-inducible factor prolyl hydroxylase (HIF-PH) enzymes, leading to stabilization of HIF-α subunits and increased erythropoietin production.
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.
At a glance
| Generic name | Molidustat (BAY85-3934) |
|---|---|
| Sponsor | Bayer |
| Drug class | HIF-PH inhibitor |
| Target | HIF-PH |
| Modality | Small molecule |
| Therapeutic area | Renal Anemia |
| Phase | Phase 3 |
Mechanism of action
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.
Approved indications
- Anemia associated with chronic kidney disease (CKD) in adults not on dialysis
- Anemia associated with CKD in adults on dialysis
Common side effects
- Hypertension
- Gastrointestinal disorders
Key clinical trials
- 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
- Maintenance Treatment of Renal Anemia in Dialysis Subjects (PHASE3)
- A Study of Molidustat for Treatment of Renal Anemia in Peritoneal Dialysis Subjects (PHASE3)
- A Study of Molidustat for Correction of Renal Anemia in Dialysis Subjects (PHASE3)
- A Study of Molidustat for Correction of Renal Anemia in Non-dialysis Subjects (PHASE3)
- A Study of Molidustat for Maintenance Treatment of Renal Anemia in Non-dialysis Subjects (PHASE3)
- Single Dose Group Stratified Study in Renal Impaired and Healthy Aged and Gender Matched Subjects (PHASE1)
- 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 (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Molidustat (BAY85-3934) CI brief — competitive landscape report
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