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 inhibitor (HIF-PHI), 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.
With our partners, AstraZeneca and Astellas, we are completing a global product development program encompassing a total of fifteen Phase 3 studies, which enrolled an estimated 10,000 patients worldwide, to support independent regulatory approvals of roxadustat in both dialysis-dependent (DD) and non-dialysis-dependent (NDD) CKD patients in the U.S., Europe, Japan, and China. The roxadustat Phase 3 clinical program follows completed Phase 1 and Phase 2 clinical trials that demonstrated correction and maintenance of hemoglobin levels in multiple subpopulations of CKD anemia patients. Roxadustat is currently approved in China for the treatment of anemia in CKD patients on dialysis and patients not on dialysis and approved in Japan for the treatment of anemia in CKD patients on dialysis. Roxadustat is in Phase 3 clinical development in the U.S. and Europe and in Phase 2/3 development in China for anemia associated with myelodysplastic syndromes (MDS), and in a Phase 2 U.S. trial for treatment of chemotherapy-induced anemia.
Additional information about roxadustat trials currently recruiting patients can be found at: www.ClinicalTrials.gov.