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Daprodustat tablets
Daprodustat is a hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor that stimulates endogenous erythropoietin production to treat anemia.
Daprodustat is a hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor that stimulates endogenous erythropoietin production to treat anemia. Used for Anemia in chronic kidney disease (CKD) patients on dialysis, Anemia in chronic kidney disease patients not on dialysis.
At a glance
| Generic name | Daprodustat tablets |
|---|---|
| Sponsor | GlaxoSmithKline |
| Drug class | HIF prolyl hydroxylase inhibitor |
| Target | Hypoxia-inducible factor prolyl hydroxylase (HIF-PH) |
| Modality | Small molecule |
| Therapeutic area | Hematology / Nephrology |
| Phase | Phase 3 |
Mechanism of action
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.
Approved indications
- Anemia in chronic kidney disease (CKD) patients on dialysis
- Anemia in chronic kidney disease patients not on dialysis
Common side effects
- Hypertension
- Hyperkalemia
- Thrombotic events
- Headache
Key clinical trials
- Comparison of Daprodustat Formulations Produced by Two Methods of Manufacture for Bioequivalence and Dissolution in Healthy Participants (PHASE1)
- 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 (PHASE4)
- 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) (PHASE3)
- Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Non-Dialysis (ASCEND-ND) (PHASE3)
- Anemia Study in Chronic Kidney Disease (CKD) : Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat -Forearm Blood Flow (ASCEND-FBF) (PHASE2)
- Anemia Studies in CKD: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat- Iron (ASCEND: Fe) (PHASE2)
- Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Dialysis (ASCEND-D) (PHASE3)
- Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-in Incident Dialysis (ASCEND-ID) (PHASE3)
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
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