Enarodustat: First Approval

Funding The preparation of this review was not supported by any external funding.

Authorship and Conflict of interest During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. A. Markham is a contracted employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

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Abstract

The orally active hypoxia inducible factor-proly hydroxylase (HIF-PH) inhibitor enarodustat (ENAROY^®, 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.

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