Product Description
Roxadustat, an oral medicine, could be the first in a new class of treatments called oral HIF-PH inhibitors that promotes erythropoiesis, or RBC production, through increased endogenous production of erythropoietin, improved iron absorption and mobilisation, and reduction of hepcidin. Roxadustat is also in clinical development for anaemia associated with MDS and for chemotherapy-induced anaemia. (Sourced from: https://www.astrazeneca.com/media-centre/press-releases/2021/update-on-us-review-of-roxadustat.html)
Mechanisms of Action: HIF Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Not Approved
Approved Countries: Austria | Bangladesh | Belgium | Chile | China | Croatia | Czech | Denmark | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hungary | Iceland | Ireland | Italy | Japan | Korea | Latvia | Lithuania | Mexico | Netherlands | Norway | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Slovakia | Slovenia | South Africa | Spain | Sweden | Turkey | Ukraine | United Arab Emirates | United Kingdom
Approved Indications: None
Known Adverse Events: None
Company: FibroGen
Company Location: SAN FRANCISCO CA 94158
Company CEO: Enrique Conterno
Additonal Commercial Interests: AstraZeneca
Clinical Description
Countries in Clinic: Belgium, Bulgaria, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Lithuania, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden
Active Clinical Trial Count: 8
Highest Development Phases
Phase 3: Anemia|Kidney Diseases|Kidney Failure, Chronic|Myelodysplastic Syndrome|Preleukemia
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| 1517-CL-1003 | P3 |
Unknown Status |
Kidney Diseases|Anemia |
2026-06-30 |
|
| 1517-CL-1003 | P3 |
Recruiting |
Anemia|Kidney Failure, Chronic |
2025-11-30 |
|
| 2017-001773-17 | P3 |
Active, not recruiting |
Anemia|Myelodysplastic Syndrome |
2023-09-27 |
|
| CTR20231278 | P1 |
Completed |
Anemia|Kidney Diseases |
2023-07-25 |