Pharmaceutical Grade Daprodustat API CAS 960539-70-2

Description

Daprodustat is a small-molecule hypoxia-inducible factor (HIF) prolyl hydroxylase (PHD) inhibitor. It was developed by GSK for the treatment of anemia in patients with chronic kidney disease (CKD). In patients with CKD, the diseased kidney cannot induce erythropoietin (EPO) production in response to hypoxia or anemia. As a potent inhibitor of PHD1, PHD2 and PHD3 (≥ 1000-fold selectivity), daprodustat leads to the stabilization of cellular HIF1α and HIF2α and the induction of erythropoiesis. A phase 3 clinical trial (NCT02879305) found that in patients with CKD undergoing dialysis, daprodustat was non-inferior to erythropoiesis-stimulating agents regarding the change in the hemoglobin level from baseline and cardiovascular outcomes. In June 2020, daprodustat was first approved in Japan for the treatment of renal anemia. Daprodustat is currently under EMA and FDA review. On October 2022, the FDA Cardiovascular and Renal Drugs Advisory Committee (CRDAC) supported that the benefit of treatment with daprodustat outweighs the risks for adult dialysis patients with anemia of CKD but not for non-dialysis patients with anemia of CKD.