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1% 他扎罗汀乳膏:首次获批用于儿科。

Tapinarof Cream 1%: Pediatric First Approval.

作者信息

Hoy Sheridan M

机构信息

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

出版信息

Paediatr Drugs. 2025 May;27(3):383-391. doi: 10.1007/s40272-025-00689-3.

DOI:10.1007/s40272-025-00689-3
PMID:40156765
Abstract

The aryl hydrocarbon receptor (AhR) has an integral role in maintaining skin homeostasis. Tapinarof cream 1% (VTAMA) is an AhR agonist developed by Dermavant Sciences, an Organon Company, as a once-daily topical treatment for plaque psoriasis and atopic dermatitis (AD). It was first approved in May 2022 in the USA for the topical treatment of plaque psoriasis in adults. It was then approved in June 2024 in Japan for the topical treatment of plaque psoriasis in adults and AD in adults and pediatric patients 12 years of age and older. In December 2024, it was approved in the USA for the topical treatment of AD in adults and pediatric patients 2 years of age and older. This article summarizes the milestones in the development of tapinarof cream 1% leading to this first pediatric approval.

摘要

芳烃受体(AhR)在维持皮肤稳态中起着不可或缺的作用。1%他扎罗汀乳膏(VTAMA)是由欧加农公司旗下的德马万特科学公司研发的一种AhR激动剂,用于治疗斑块状银屑病和特应性皮炎(AD),每日一次局部用药。它于2022年5月在美国首次获批用于成人斑块状银屑病的局部治疗。随后于2024年6月在日本获批用于成人斑块状银屑病以及成人和12岁及以上儿童患者的AD的局部治疗。2024年12月,它在美国获批用于成人和2岁及以上儿童患者AD的局部治疗。本文总结了1%他扎罗汀乳膏研发过程中促成此次首次儿科批准的各个重要节点。

相似文献

1
Tapinarof Cream 1%: Pediatric First Approval.1% 他扎罗汀乳膏:首次获批用于儿科。
Paediatr Drugs. 2025 May;27(3):383-391. doi: 10.1007/s40272-025-00689-3.
2
Tapinarof Cream 1%: First Approval.他卡西醇乳膏 1%:美国批准。
Drugs. 2022 Jul;82(11):1221-1228. doi: 10.1007/s40265-022-01748-6.
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Targeting the Aryl Hydrocarbon Receptor to Address the Challenges of Atopic Dermatitis.针对芳香烃受体以应对特应性皮炎的挑战。
J Drugs Dermatol. 2024 Feb 1;23(2):23-28. doi: 10.36849/JDD.8026.
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Tapinarof, a Novel, First-in-Class, Topical Therapeutic Aryl Hydrocarbon Receptor Agonist for the Management of Psoriasis.他卡西醇,一种新型、首创的、局部用芳香烃受体激动剂,用于治疗银屑病。
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A phase 2, randomized, double-blind, vehicle-controlled trial of tapinarof cream in Japanese pediatric patients with atopic dermatitis.一项针对日本特应性皮炎儿科患者的他扎罗汀乳膏2期随机双盲赋形剂对照试验。
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Tapinarof cream 1% once daily: Significant efficacy in the treatment of moderate to severe atopic dermatitis in adults and children down to 2 years of age in the pivotal phase 3 ADORING trials.他卡西醇乳膏 1%,每日一次:在关键的 3 期 ADORING 试验中,对于 2 岁及以上的中重度特应性皮炎成人和儿童患者,具有显著疗效。
J Am Acad Dermatol. 2024 Sep;91(3):457-465. doi: 10.1016/j.jaad.2024.05.023. Epub 2024 May 20.

本文引用的文献

1
Long-Term Safety and Tolerability of Beremagene Geperpavec-svdt (B-VEC) in an Open-Label Extension Study of Patients with Dystrophic Epidermolysis Bullosa.在营养不良性大疱性表皮松解症患者的开放标签扩展研究中,beremagene geperpavec-svdt(B-VEC)的长期安全性和耐受性
Am J Clin Dermatol. 2025 Apr 12. doi: 10.1007/s40257-025-00942-y.
2
Maximal Usage Trial of Tapinarof Cream 1% Once Daily in Pediatric Patients Down to 2 Years of Age with Extensive Atopic Dermatitis.1% 他扎罗汀乳膏每日一次用于2岁及以下广泛性特应性皮炎儿科患者的最大用量试验。
Am J Clin Dermatol. 2025 May;26(3):449-456. doi: 10.1007/s40257-025-00929-9. Epub 2025 Mar 24.
3
A phase 2, randomized, double-blind, vehicle-controlled trial of tapinarof cream in Japanese pediatric patients with atopic dermatitis.
一项针对日本特应性皮炎儿科患者的他扎罗汀乳膏2期随机双盲赋形剂对照试验。
J Dermatol. 2025 Feb;52(2):247-255. doi: 10.1111/1346-8138.17587. Epub 2024 Dec 15.
4
Tapinarof cream for the treatment of atopic dermatitis: Efficacy and safety results from two Japanese phase 3 trials.他卡西醇乳膏治疗特应性皮炎的疗效和安全性:两项日本 3 期临床试验结果。
J Dermatol. 2024 Nov;51(11):1404-1413. doi: 10.1111/1346-8138.17451. Epub 2024 Sep 13.
5
Tapinarof cream 1% once daily: Significant efficacy in the treatment of moderate to severe atopic dermatitis in adults and children down to 2 years of age in the pivotal phase 3 ADORING trials.他卡西醇乳膏 1%,每日一次:在关键的 3 期 ADORING 试验中,对于 2 岁及以上的中重度特应性皮炎成人和儿童患者,具有显著疗效。
J Am Acad Dermatol. 2024 Sep;91(3):457-465. doi: 10.1016/j.jaad.2024.05.023. Epub 2024 May 20.
6
Targeting the Aryl Hydrocarbon Receptor to Address the Challenges of Atopic Dermatitis.针对芳香烃受体以应对特应性皮炎的挑战。
J Drugs Dermatol. 2024 Feb 1;23(2):23-28. doi: 10.36849/JDD.8026.
7
Targeting the aryl hydrocarbon receptor as a strategy to expand the therapeutic armamentarium in atopic dermatitis.以芳烃受体为靶点作为扩大特应性皮炎治疗手段的一种策略。
J Dermatolog Treat. 2024 Dec;35(1):2300354. doi: 10.1080/09546634.2023.2300354. Epub 2024 Jan 11.
8
Tapinarof for psoriasis and atopic dermatitis: 15 years of clinical research.他卡西醇治疗银屑病和特应性皮炎:15 年临床研究。
J Eur Acad Dermatol Venereol. 2023 Jun;37(6):1168-1174. doi: 10.1111/jdv.18925. Epub 2023 Feb 13.
9
Biologics in the management of childhood atopic dermatitis.生物制剂在儿童特应性皮炎治疗中的应用
J Allergy Clin Immunol. 2023 Mar;151(3):681-685. doi: 10.1016/j.jaci.2023.01.010. Epub 2023 Jan 20.
10
What's New in Topicals for Atopic Dermatitis?特应性皮炎的局部治疗有哪些新进展?
Am J Clin Dermatol. 2022 Sep;23(5):595-603. doi: 10.1007/s40257-022-00712-0. Epub 2022 Sep 1.