Desidustat Tablet is a novel oral HIF-PHI, which promotes erythropoiesis through increasing endogenous erythropoietin, improving iron availability, and reducing hepcidin, so as to treat anemia caused by CKD. It is administrated orally and has good efficacy, safety and treatment compliance. The product has been approved for marketing in India.
This marketing approval in India was based on two phase III clinical trials (DREAM-D and DREAM-ND), which enrolled 392 dialysis CKD patients and 588 non-dialysis CKD patients accordingly. Both studies met their primary endpoints for hemoglobin (Hb) improvement. In the Desidustat group of both trials, mean Hb increased and reached the predefined target of 10.0-12.0 g/dl in patients and was maintained within the target range for 24 weeks. The product also showed a good safety profile, downregulation of hepcidin, improved iron mobilization, and LDL-C reduction.
It is estimated that more than 120 million people are living with CKD in China, and anemia is one of the frequent complications of CKD. The prevalence of anemia in patients at CKD stage 1 to 5 were 22.0%, 37.0%, 45.4%, 85.1%, and 98.2%, respectively, however, the target-achieving rate was only 8.2% for anemia patients in non-dialysis CKD and 35.2% for hemodialysis CKD. Desidustat tablet is expected to meet the unmet treatment need once it gets approved for marketing.