Overview
Daprodustat is a small-molecule hypoxia-inducible factor (HIF) prolyl hydroxylase (PHD) inhibitor that was developed by GSK. Patients with CKD cannot induce erythropoietin (EPO) production in response to hypoxia or anemia. As a potent inhibitor of PHD1, PHD2 and PHD3 (≥ 1000-fold selectivity), daprodustat stabilizes cellular HIF1α and HIF2α and the induces erythropoiesis. A phase 3 clinical trial (NCT02879305) found that in patients with CKD undergoing dialysis, daprodustat was non-inferior to erythropoiesis-stimulating agents regarding the change in the hemoglobin level from baseline and cardiovascular outcomes. In June 2020, daprodustat was first approved in Japan for the treatment of renal anemia. On October 2022, the FDA Cardiovascular and Renal Drugs Advisory Committee (CRDAC) supported that the benefit of treatment with daprodustat outweighs the risks for adult dialysis patients with anemia of CKD but not for non-dialysis patients with anemia of CKD. On February 1, 2023, daprodustat was fully approved by the FDA as the first oral treatment for anemia caused by chronic kidney disease in patients on dialysis. The drug is currently under EMA review.
Indication
用于治疗由慢性肾脏病（CKD）导致的肾性贫血，包括透析和非透析CKD患者。
Associated Conditions
- Anemia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/07/18 | Phase 4 | Completed | USRC Kidney Research | ||
2023/01/12 | Phase 3 | Completed | |||
2020/11/23 | Phase 1 | Completed | |||
2018/04/10 | Phase 1 | Completed | |||
2018/03/07 | Phase 2 | Completed | |||
2018/02/27 | Phase 2 | Terminated | |||
2018/01/24 | Phase 3 | Completed | |||
2018/01/17 | Phase 3 | Completed | |||
2017/08/04 | Phase 1 | Completed | |||
2017/07/21 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| GlaxoSmithKline LLC | 0173-0897 | ORAL | 1 mg in 1 1 | 8/30/2023 | |
| GlaxoSmithKline LLC | 0173-0914 | ORAL | 8 mg in 1 1 | 8/30/2023 | |
| GlaxoSmithKline LLC | 0173-0906 | ORAL | 4 mg in 1 1 | 8/30/2023 | |
| GlaxoSmithKline LLC | 0173-0903 | ORAL | 2 mg in 1 1 | 8/30/2023 | |
| GlaxoSmithKline LLC | 0173-0911 | ORAL | 6 mg in 1 1 | 8/30/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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