Enarodustat: First Approval
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ADISINSIGHT REPORT
Enarodustat: First Approval Anthony Markham1
© Springer Nature Switzerland AG 2020
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.
Enarodustat ( ENAROY®): Key points A hypoxia inducible factor prolyl hydroxylase (HIF-PH) inhibitor is being developed by Japan Tobacco for the treatment of anaemia associated with chronic kidney disease. Received its first approval on 25 September 2020 in Japan. Approved for use in patients with anaemia associated with chronic kidney disease.
1 Introduction Enarodustat (ENAROY®) is an orally active inhibitor of hypoxia inducible factor-proly hydroxylase (HIF-PH) being developed by Japan Tobacco for the treatment of anaemia Enhanced material for this AdisInsight Report can be found at https://doi.org/10.6084/m9.figshare.13217759 This profile has been extracted and modified from the AdisInsight database. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through preclinical and clinical studies to market launch and beyond. * Anthony Markham [email protected] 1
Springer Nature, Private Bag 65901, Mairangi Bay, Auckland 0754, New Zealand
associated with chronic kidney disease (CKD). Anaemia in patients with CKD occurs as a result of inadequate erythropoietin production by the failing kidney, and injectable recombinant erythropoietin stimulating agents such as epoetin and darbepoetin are widely used to restore haemoglobin levels. Production of erythropoietin is regulated by HIF with the activity of the HIF-α subunit regulated by PH domaincontaining protein [1]. HIF-PH inhibitors such as enarodustat restrict the breakdown of HIF-α leading to increased endogenous erythropoietin production [2]. Enarodustat received its first approval on 25 September 2020 in Japan for the treatment of anaemia associated with CKD [3, 4]. Clinical development for enarodustat is ongoing in the USA and South Korea. The recommended starting dose of enarodustat is 2 mg once daily in patients with CKD not on dialysis and those on peritoneal dialysis and 4 mg once daily in patients on haemodialysis titrated to a maximum dose of 8 mg once daily according to response [4].
1.1 Company Agreements In October 2016 Japan Tobacco entered into an exclusive license agreement with JW Pharmaceutical (JW) for the development and commercialization of enarodustat in South Korea for treatment of anaemia associated with CKD. Under the terms of the agreement JW will be responsible for clinical and commercial activities in the Republic of Korea [5]. In October 201
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