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Daprodustat (GSK1278863)
Daprodustat (GSK1278863) is a HIF prolyl hydroxylase inhibitor Small molecule drug developed by GlaxoSmithKline. It is currently in Phase 3 development for Anemia of chronic kidney disease, Anemia in patients with chronic kidney disease not on dialysis.
Daprodustat inhibits hypoxia-inducible factor prolyl hydroxylase (HIF-PH), stabilizing HIF and increasing endogenous erythropoietin production to treat anemia.
Daprodustat inhibits hypoxia-inducible factor prolyl hydroxylase (HIF-PH), stabilizing HIF and increasing endogenous erythropoietin production to treat anemia. Used for Anemia of chronic kidney disease, Anemia in patients with chronic kidney disease not on dialysis.
At a glance
| Generic name | Daprodustat (GSK1278863) |
|---|---|
| Sponsor | GlaxoSmithKline |
| Drug class | HIF prolyl hydroxylase inhibitor |
| Target | Prolyl hydroxylase domain-containing proteins (PHD) |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | Phase 3 |
Mechanism of action
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.
Approved indications
- Anemia of chronic kidney disease
- Anemia in patients with chronic kidney disease not on dialysis
Common side effects
- Hypertension
- Headache
- Diarrhea
- Nausea
- Thrombotic events
Key clinical trials
- REDCURE Registry for Chronic Kidney Disease (CKD) Anemia
- A Study to Evaluate Efficacy and Safety of QLG1218(Daprodustat) in Chinese Hemodialysis (HD)-Dependent Subjects With Anemia Associated With Chronic Kidney Disease (CKD) (PHASE3)
- Anemia Studies in CKD: Erythropoiesis Via a Novel PHI Daprodustat - Pediatric (ASCEND-P) (PHASE3)
- 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)
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:
- Daprodustat (GSK1278863) CI brief — competitive landscape report
- Daprodustat (GSK1278863) updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about Daprodustat (GSK1278863)
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Who makes Daprodustat (GSK1278863)?
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Related
- Drug class: All HIF prolyl hydroxylase inhibitor drugs
- Target: All drugs targeting Prolyl hydroxylase domain-containing proteins (PHD)
- Manufacturer: GlaxoSmithKline — full pipeline
- Therapeutic area: All drugs in Hematology
- Indication: Drugs for Anemia of chronic kidney disease
- Indication: Drugs for Anemia in patients with chronic kidney disease not on dialysis
- Compare: Daprodustat (GSK1278863) vs similar drugs
- Pricing: Daprodustat (GSK1278863) cost, discount & access