Enarodustat: First Approval

The orally active hypoxia inducible factor-proly hydroxylase (HIF-PH) inhibitor enarodustat (ENAROY(R), Japan Tobacco) is being developed as an alternative to injectable erythropoietin stimulating agents such as epoetin and darbepoetin for the treatment of anaemia associated with chronic kidney disease (CKD). The drug is approved in Japan and clinical development is ongoing in the USA and South Korea. This article summarizes the milestones in the development of enarodustat leading to this first approval for anaemia associated with CKD.

Automated summary

Enarodustat, an orally active HIF-PH inhibitor, is being developed as an alternative to injectable erythropoiesis-stimulating agents for the treatment of anemia associated with CKD. Approved in Japan, the drug is currently undergoing clinical development in the USA and South Korea. This article outlines the key milestones in the development of enarodustat leading to its first approval for CKD-associated anemia.