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地夸磷索钠:美国批准

Delgocitinib: First Approval.

机构信息

Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.

出版信息

Drugs. 2020 Apr;80(6):609-615. doi: 10.1007/s40265-020-01291-2.

DOI:10.1007/s40265-020-01291-2
PMID:32166597
Abstract

Delgocitinib, a janus kinase (JAK) inhibitor, is being developed by Japan Tobacco for the treatment of autoimmune disorders and hypersensitivity, including inflammatory skin conditions. The JAK family of tyrosine kinases plays an important role in mediating the biological effects of several inflammatory cytokines, e.g. IL-4, IL-13 and IL-31, which are elevated in patients with atopic dermatitis. Delgocitinib inhibits all members of the JAK family [JAK1, JAK2, JAK3 and tyrosine kinase 2]. Topical delgocitinib (Corectim) is approved in Japan for the treatment of atopic dermatitis. This article summarizes the milestones in the development of delgocitinib leading to this first approval for the treatment of adults with atopic dermatitis. Clinical development of the topical formulation is also underway for alopecia areata, chronic hand eczema, discoid lupus erythematosus, inverse psoriasis and atopic dermatitis in several countries worldwide. Clinical development of an oral formulation of delgocitinib is also underway in Japan for the treatment of autoimmune disorders and hypersensitivity.

摘要

地夸磷索钠,一种 Janus 激酶(JAK)抑制剂,由日本烟草公司研发,用于治疗自身免疫性疾病和过敏症,包括炎症性皮肤病。JAK 家族酪氨酸激酶在介导几种炎症细胞因子的生物学效应中发挥重要作用,例如在特应性皮炎患者中升高的白细胞介素-4、白细胞介素-13 和白细胞介素-31。地夸磷索钠抑制 JAK 家族的所有成员[JAK1、JAK2、JAK3 和酪氨酸激酶 2]。局部用地夸磷索钠(Corectim)在日本被批准用于治疗特应性皮炎。本文总结了地夸磷索钠开发过程中的重要里程碑,导致其首次获批用于治疗成人特应性皮炎。该局部制剂的临床开发也在全球多个国家进行,用于治疗斑秃、慢性手部湿疹、盘状红斑狼疮、反向银屑病和特应性皮炎。地夸磷索钠的口服制剂的临床开发也在日本进行,用于治疗自身免疫性疾病和过敏症。

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J Am Acad Dermatol. 2020 Apr;82(4):823-831. doi: 10.1016/j.jaad.2019.12.015. Epub 2020 Feb 3.
2
Long-term safety and efficacy of delgocitinib ointment, a topical Janus kinase inhibitor, in adult patients with atopic dermatitis.地夸磷索钠滴眼液治疗干眼的随机、双盲、安慰剂对照多中心临床试验
J Dermatol. 2020 Feb;47(2):114-120. doi: 10.1111/1346-8138.15173. Epub 2019 Dec 9.
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