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01-01-2021 | Erythropoietin | AdisInsight Report

Enarodustat: First Approval

Author: Anthony Markham

Published in: Drugs | Issue 1/2021

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.

Zheng Q, Yang H, Sun L, et al. Efficacy and safety of HIF prolyl-hydroxylase inhibitor vs epoetin and darbepoetin for anemia in chronic kidney disease patients not undergoing dialysis: a network meta-analysis. Pharmacol Res. 2020;159:105020.CrossRef

Akizawa T, Nangaku M, Yamaguchi T, et al. A placebo-controlled, randomized trial of enarodustat in patients with chronic kidney disease followed by long-term trial. Am J Nephrol. 2019a;49(2):165–74.CrossRef

Japan Tobacco. JT receives manufacturing and marketing approval of ENAROY^® tablets 2 mg·4 mg for the treatment of anemia associated with chronic kidney disease in Japan [media release]. 25 Sept 2020. https://www.jt.com/media/news/2020/pdf/20200925_E1.pdf.

Japan Tobacco Inc. ENAROY®: Japanese prescribing information. 2020. https://www.pmda.go.jp. Accessed 8 Oct 2020.

Japan Tobacco. JT signs exclusive license agreement with JW Pharmaceutical for development and commercialization of HIF-PHD inhibitor in Republic of Korea [media release]. 14 Oct 2016. https://www.jt.com/media/news/index.html?year=2016&page=2.

Torii Pharmaceutical, Japan Tobacco. JT and Torii sign exclusive license agreement for development and commercialization of HIF-PH inhibitor in Japan [media release]. 26 Oct 2017. https://www.torii.co.jp/en/release/2017/20171026_E.pdf.

Japan Tobacco. JT signs exclusive license agreement with Salubris for the development and commercialization of enarodustat (JTZ-951) [media release]. 25 Dec 2019. https://www.jt.com/media/news/2019/pdf/20191225_E01.pdf.

Fukui K, Shinozaki Y, Kobayashi H, et al. JTZ-951 (enarodustat), a hypoxia-inducibe factor prolyl hydroxylase inhibitor, stabilizes HIF-α protein and induces erythropoiesis without effects on the function of vascular endothelial growth factor. Eur J Pharmacol. 2019;859:1–7.CrossRef

Ogoshi Y, Matsui T, Mitani I, et al. Discovery of JTZ-951: a HIF prolyl hydroxylase inhibitor for the treatment of renal anemia. ACS Med Chem Lett. 2017;8(12):1320–5.CrossRef

10.

Pai SM, Connaire J, Yamada H, et al. A mass balance study of (14)C-labeled JTZ-951 (enarodustat), a novel orally available erythropoiesis-stimulating agent, in patients with end-stage renal disease on hemodialysis. Clin Pharmacol Drug Dev. 2020;9(6):728–41.CrossRef

11.

Akizawa T, Maeda K, Miyazawa Y, et al. Phase 3 study to compare the efficacy and safety of enarodustat (JTZ-951), an oral HIF-PH inhibitor, with darbepoetin alfa in anemic patients with CKD receiving maintenance hemodialysis [abstract no. TH-PO1186]. J Am Soc Nephrol. 2019;30(Suppl):B4.

12.

Akizawa T, Nangaku M, Yamaguchi T, et al. Enarodustat, conversion and maintenance therapy for anemia in hemodialysis patients: a randomized, placebo-controlled phase 2b trial followed by long-term trial. Nephron. 2019b;143(2):77–85.CrossRef

13.

Akizawa T, Matsui A, Miyazawa Y, et al. Phase 3 study to compare the efficacy and safety of enarodustat (JTZ-951), an oral HIF-PH inhibitor, with darbepoetin alfa in anemic patients with CKD not requiring dialysis [abstract no. TH-PO1185]. J Am Soc Nephrol. 2019;30(Suppl):B4.

Title: Enarodustat: First Approval
Author: Anthony Markham
Publication date: 01-01-2021
Publisher: Springer International Publishing
Keywords: Erythropoietin
Erythropoietin
Chronic Kidney Disease
Epoetin alfa
Published in: Drugs / Issue 1/2021
Print ISSN: 0012-6667
Electronic ISSN: 1179-1950
DOI: https://doi.org/10.1007/s40265-020-01444-3

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Enarodustat: First Approval

Abstract

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Abstract

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