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Jesduvroq (DAPRODUSTAT)
Jesduvroq works by activating hypoxia-inducible factor prolyl hydroxylase inhibitors, which increases the production of erythropoietin, a hormone that stimulates red blood cell production.
At a glance
| Generic name | DAPRODUSTAT |
|---|---|
| Sponsor | GSK |
| Drug class | Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor [EPC] |
| Target | Egl nine homolog 1 |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | FDA-approved |
| First approval | 2023 |
Mechanism of action
Daprodustat is reversible inhibitor of HIF-PH1, PH2 and PH3 (IC50 in the low nM range). This activity results in the stabilization and nuclear accumulation of HIF-1 and HIF-2 transcription factors, leading to increased transcription of the HIF-responsive genes, including erythropoietin.
Approved indications
- Anemia in chronic kidney disease
- Anemia of renal disease
Boxed warnings
- WARNING: INCREASED RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, and THROMBOSIS OF VASCULAR ACCESS JESDUVROQ increases the risk of thrombotic vascular events, including major adverse cardiovascular events (MACE) [see Warnings and Precautions ( 5.1 )] . Targeting a hemoglobin level greater than 11 g/dL is expected to further increase the risk of death and arterial venous thrombotic events, as occurs with erythropoietin stimulating agents (ESAs), which also increase erythropoietin levels [see Warnings and Precautions ( 5.1 )] . No trial has identified a hemoglobin target level, dose of JESDUVROQ, or dosing strategy that does not increase these risks [see Dosage and Administration ( 2.4 )]. Use the lowest dose of JESDUVROQ sufficient to reduce the need for red blood cell transfusions [see Dosage and Administration ( 2.4 )] . WARNING: INCREASED RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, and THROMBOSIS OF VASCULAR ACCESS See full prescribing information for complete boxed warning. • JESDUVROQ increases the risk of thrombotic vascular events, including major adverse cardiovascular events (MACE). ( 5.1 ) • Targeting a hemoglobin level greater than 11 g/dL is expected to further increase the risk of death and arterial venous thrombotic events, as occurs with erythropoietin stimulating agents (ESAs), which also increase erythropoietin levels. ( 5.1 ) • No trial has identified a hemoglobin target level, dose of JESDUVROQ, or dosing strategy that does not increase these risks. ( 2.4 ) • Use the lowest dose of JESDUVROQ sufficient to reduce the need for red blood cell transfusions. ( 2.4 )
Common side effects
- Hypertension
- Abdominal pain
- Dizziness
- Hypersensitivity
- Thrombotic Vascular Events
- Vascular access thrombosis
- Myocardial infarction
- Stroke
- Deep vein thrombosis
- Pulmonary embolism
- rhEPO Recombinant human erythropoietin
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)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Jesduvroq CI brief — competitive landscape report
- Jesduvroq updates RSS · CI watch RSS
- GSK portfolio CI