Roxadustat Trials 

Roxadustat is approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in chronic kidney disease (CKD) patients on dialysis and patients not on dialysis. Several other licensing applications for roxadustat have been submitted by partners, Astellas and AstraZeneca to regulatory authorities across the globe, and are currently under review. The U.S. Food and Drug Administration issued a complete response letter for the roxadustat NDA filing for the treatment of CKD anemia in August 2021. Roxadustat is in Phase 3 clinical development in China for the treatment of chemotherapy-induced anemia (CIA). The goal of these clinical studies is to evaluate the safety and efficacy of the first oral hypoxia-inducible factor prolyl hydroxylase inhibitor therapy for the treatment of anemia.