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Clin Gastroenterol Hepatol. 2024 Jan;22(1):144-153.e2. doi: 10.1016/j.cgh.2023.06.014. Epub 2023 Jun 28.
2
Efficacy and safety of ritlecitinib in adults and adolescents with alopecia areata: a randomised, double-blind, multicentre, phase 2b-3 trial.利特昔替尼治疗成人和青少年斑秃的疗效和安全性:一项随机、双盲、多中心、2b-3 期临床试验。
Lancet. 2023 May 6;401(10387):1518-1529. doi: 10.1016/S0140-6736(23)00222-2. Epub 2023 Apr 14.
3
Evaluation of the effect of ritlecitinib on the pharmacokinetics of caffeine in healthy participants.评估利特昔替尼对健康参与者体内咖啡因药代动力学的影响。
Br J Clin Pharmacol. 2023 Jul;89(7):2208-2215. doi: 10.1111/bcp.15695. Epub 2023 Mar 2.
4
Efficacy and safety of oral ritlecitinib for the treatment of active nonsegmental vitiligo: A randomized phase 2b clinical trial.口服瑞特替尼治疗活动性非节段性白癜风的疗效和安全性:一项随机 2b 期临床试验。
J Am Acad Dermatol. 2023 Feb;88(2):395-403. doi: 10.1016/j.jaad.2022.11.005. Epub 2022 Nov 9.
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JID Innov. 2022 Sep 7;2(6):100156. doi: 10.1016/j.xjidi.2022.100156. eCollection 2022 Nov.
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Maintenance, withdrawal, and re-treatment with ritlecitinib and brepocitinib in patients with alopecia areata in a single-blind extension of a phase 2a randomized clinical trial.在一项2a期随机临床试验的单盲扩展试验中,对斑秃患者使用利特昔替尼和布雷西替尼进行维持、撤药及再治疗。
J Am Acad Dermatol. 2022 Aug;87(2):390-393. doi: 10.1016/j.jaad.2021.12.008. Epub 2021 Dec 13.
7
A phase 2a randomized, placebo-controlled study to evaluate the efficacy and safety of the oral Janus kinase inhibitors ritlecitinib and brepocitinib in alopecia areata: 24-week results.一项评估口服 Janus 激酶抑制剂 ritlecitinib 和 brepocitinib 治疗斑秃的疗效和安全性的 2a 期随机、安慰剂对照研究:24 周结果。
J Am Acad Dermatol. 2021 Aug;85(2):379-387. doi: 10.1016/j.jaad.2021.03.050. Epub 2021 Mar 20.
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PF-06651600, a Dual JAK3/TEC Family Kinase Inhibitor.PF-06651600,一种双重 JAK3/TEC 家族激酶抑制剂。
ACS Chem Biol. 2019 Jun 21;14(6):1235-1242. doi: 10.1021/acschembio.9b00188. Epub 2019 May 22.
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Discovery of a JAK3-Selective Inhibitor: Functional Differentiation of JAK3-Selective Inhibition over pan-JAK or JAK1-Selective Inhibition.一种JAK3选择性抑制剂的发现:JAK3选择性抑制相对于泛JAK或JAK1选择性抑制的功能差异
ACS Chem Biol. 2016 Dec 16;11(12):3442-3451. doi: 10.1021/acschembio.6b00677. Epub 2016 Nov 10.

瑞特西替尼:首次批准。

Ritlecitinib: First Approval.

机构信息

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

出版信息

Drugs. 2023 Sep;83(14):1315-1321. doi: 10.1007/s40265-023-01928-y.

DOI:10.1007/s40265-023-01928-y
PMID:37556041
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10556173/
Abstract

Ritlecitinib (LITFULO), an orally administered kinase inhibitor, is being developed by Pfizer for the treatment of alopecia areata, vitiligo, ulcerative colitis and Crohn's disease. On 23 June 2023, ritlecitinib received approval in the USA for the treatment of severe alopecia areata in adults and adolescents 12 years and older. Ritlecitinib was approved in Japan on 26 June 2023 for the treatment of alopecia areata (limited to intractable cases involving widespread hair loss). Ritlecitinib has also received a positive opinion in the EU and is under regulatory review in the UK and China. This article summarizes the milestones in the development of ritlecitinib leading to this first approval for severe alopecia areata.

摘要

利特昔替尼(LITFULO)是一种口服激酶抑制剂,由辉瑞公司开发,用于治疗斑秃、白癜风、溃疡性结肠炎和克罗恩病。2023 年 6 月 23 日,利特昔替尼获得美国批准,用于治疗成人和 12 岁及以上青少年的重度斑秃。2023 年 6 月 26 日,利特昔替尼在日本获批用于治疗斑秃(仅限于涉及广泛脱发的难治性病例)。利特昔替尼在欧盟也获得了积极意见,正在英国和中国接受监管审查。本文总结了利特昔替尼开发的里程碑事件,最终使其获得了重度斑秃的首次批准。