Redefining How to Treat Anemia in Chronic Kidney Disease
We are advancing roxadustat, our first-in-class, oral small molecule product candidate for the treatment of anemia associated with chronic kidney disease (CKD), through global Phase 3 clinical development.
Roxadustat, a hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, promotes coordinated erythropoiesis through increasing endogenous erythropoietin, improving iron availability, and reducing hepcidin. Administration of roxadustat has been shown to increase red blood cell production while maintaining plasma erythropoietin levels within or near normal physiologic range in multiple subpopulations of CKD patients, including in the presence of inflammation, and without a need for supplemental intravenous iron.
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 the U.S., Europe, and China for anemia associated with myelodysplastic syndromes (MDS), and in a Phase 2 U.S. trial for treatment of chemotherapy-induced anemia (CIA).
Additional information about roxadustat trials currently recruiting patients can be found at