Overview
Roxadustat is a first-in-class hypoxia-inducible factor prolyl hydroxylase inhibitor used to treat anemia associated with chronic kidney disease. It works by reducing the breakdown of the hypoxia-inducible factor (HIF), which is a transcription factor that stimulates red blood cell production in response to low oxygen levels. Roxadustat was first approved by the European Commission in August 2021.
Background
Roxadustat is a first-in-class hypoxia-inducible factor prolyl hydroxylase inhibitor used to treat anemia associated with chronic kidney disease. It works by reducing the breakdown of the hypoxia-inducible factor (HIF), which is a transcription factor that stimulates red blood cell production in response to low oxygen levels. Roxadustat was first approved by the European Commission in August 2021.
Indication
Roxadustat is indicated for the treatment of adult patients with symptomatic anemia associated with chronic kidney disease (CKD).
Associated Conditions
- Anemia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/04/09 | Phase 1 | Recruiting | |||
2025/03/30 | Phase 1 | Recruiting | |||
2025/01/13 | Phase 3 | Active, not recruiting | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||
2023/11/03 | Phase 4 | Recruiting | |||
2023/09/01 | Phase 1 | Not yet recruiting | |||
2023/08/23 | Phase 4 | Not yet recruiting | |||
2023/08/01 | Phase 3 | Recruiting | |||
2023/04/12 | Phase 2 | Not yet recruiting | |||
2023/01/19 | Phase 4 | Not yet recruiting | China-Japan Friendship Hospital | ||
2022/03/29 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 8/18/2021 | ||
Authorised | 8/18/2021 |
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 |
|---|---|---|---|---|---|
| Roxadustat Capsules | 国药准字H20249771 | 化学药品 | 胶囊剂 | 12/25/2024 | |
| Roxadustat Capsules | 国药准字H20253115 | 化学药品 | 胶囊剂 | 1/8/2025 | |
| Roxadustat Capsules | 国药准字H20249824 | 化学药品 | 胶囊剂 | 12/25/2024 | |
| Roxadustat Capsules | 国药准字H20253116 | 化学药品 | 胶囊剂 | 1/8/2025 | |
| Roxadustat Capsules | 国药准字H20249733 | 化学药品 | 胶囊剂 | 12/17/2024 | |
| Roxadustat Capsules | 国药准字H20249825 | 化学药品 | 胶囊剂 | 12/25/2024 | |
| Roxadustat Capsules | 国药准字H20249730 | 化学药品 | 胶囊剂 | 12/17/2024 | |
| Roxadustat Capsules | 国药准字H20249729 | 化学药品 | 胶囊剂 | 12/17/2024 | |
| Roxadustat Capsules | 国药准字H20253093 | 化学药品 | 胶囊剂 | 1/8/2025 | |
| Roxadustat Capsules | 国药准字H20253087 | 化学药品 | 胶囊剂 | 1/8/2025 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| ♐♇ EVRENZO CAPSULES 50MG | N/A | N/A | N/A | 11/8/2024 | |
| ♐♇ EVRENZO CAPSULES 20MG | N/A | N/A | N/A | 11/8/2024 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||