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贝达西莫局部凝胶,10.3%:首次批准。

Berdazimer Topical Gel, 10.3%: First Approval.

机构信息

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

出版信息

Drugs. 2024 Mar;84(3):363-368. doi: 10.1007/s40265-024-02012-9.

DOI:10.1007/s40265-024-02012-9
PMID:38409574
Abstract

Berdazimer topical gel, 10.3% (ZELSUVMI™) is a nitric oxide (NO) releasing topical gel developed by Novan Inc. (a Ligand Pharmaceuticals company) for the treatment of molluscum contagiosum (MC). Novan has used their proprietary NO-based technology platform (NITRICIL™), which stores gaseous NO species on large polymers, in the development of berdazimer topical gel, 10.3%. In January 2024, berdazimer topical gel, 10.3% was approved for the topical treatment of MC in adult and paediatric patients 1 year of age and older in the USA. This article summarizes the milestones in the development of berdazimer topical gel, 10.3% leading to this first approval for the treatment of MC.

摘要

贝达西莫特局部凝胶,10.3%(ZELSUVMI™)是一种由 Novan Inc.(利兰制药公司)开发的释放一氧化氮(NO)的局部凝胶,用于治疗传染性软疣(MC)。Novan 公司利用其专有的基于一氧化氮的技术平台(NITRICIL™),将气态的 NO 物种储存在大聚合物上,开发了贝达西莫特局部凝胶,10.3%。2024 年 1 月,贝达西莫特局部凝胶,10.3%在美国获得批准,用于治疗 1 岁及以上成人和儿科患者的 MC。本文总结了贝达西莫特局部凝胶,10.3%的开发过程中的重要里程碑,最终获得了治疗 MC 的首次批准。

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Berdazimer Sodium: A Novel Nitric Oxide-Releasing Drug in Dermatology.贝达齐默钠:皮肤科一种新型一氧化氮释放药物。
Indian Dermatol Online J. 2025 Jan 20;16(2):359-362. doi: 10.4103/idoj.idoj_259_24. eCollection 2025 Mar-Apr.

本文引用的文献

1
New Developing Treatments for Molluscum Contagiosum.传染性软疣的新研发治疗方法
Dermatol Ther (Heidelb). 2022 Dec;12(12):2669-2678. doi: 10.1007/s13555-022-00826-7. Epub 2022 Oct 14.
2
Pharmacokinetic Profile, Safety, and Tolerability of Topical Berdazimer Gel, 10.3% in Patients With Molluscum Contagiosum.局部贝达莫司凝胶,10.3%治疗传染性软疣患者的药代动力学特征、安全性和耐受性。
J Drugs Dermatol. 2022 Oct 1;21(10):1104-1110. doi: 10.36849/JDD.6938.
3
Efficacy and Safety of Topical Nitric Oxide-Releasing Berdazimer Gel in Patients With Molluscum Contagiosum: A Phase 3 Randomized Clinical Trial.
局部释放一氧化氮的贝达西美凝胶治疗传染性软疣患者的疗效和安全性:一项 3 期随机临床试验。
JAMA Dermatol. 2022 Aug 1;158(8):871-878. doi: 10.1001/jamadermatol.2022.2721.
4
Molluscum Contagiosum Therapeutics-New Options May Be Around the Corner.传染性软疣的治疗——新选择或许即将出现。
JAMA Dermatol. 2022 Aug 1;158(8):863-864. doi: 10.1001/jamadermatol.2022.2719.
5
Therapeutic Approaches and Special Considerations for Treating Molluscum Contagiosum.治疗传染性软疣的方法和特殊注意事项。
J Drugs Dermatol. 2021 Nov 1;20(11):1185-1190. doi: 10.36849/jdd.6383.
6
Efficacy and tolerability of an investigational nitric oxide-releasing topical gel in patients with molluscum contagiosum: A randomized clinical trial.一种新型一氧化氮释放局部凝胶治疗传染性软疣的疗效和耐受性:一项随机临床试验。
J Am Acad Dermatol. 2020 Apr;82(4):887-894. doi: 10.1016/j.jaad.2019.09.064. Epub 2019 Oct 3.
7
Spotlight on the Use of Nitric Oxide in Dermatology: What Is It? What Does It Do? Can It Become an Important Addition to the Therapeutic Armamentarium for Skin Disease?聚焦一氧化氮在皮肤病学中的应用:它是什么?有什么作用?它能否成为皮肤病治疗手段的重要补充?
J Drugs Dermatol. 2017 Jan 1;16(1):s4-s10.
8
Time to resolution and effect on quality of life of molluscum contagiosum in children in the UK: a prospective community cohort study.英国儿童传染性软疣的消退时间及其对生活质量的影响:一项前瞻性社区队列研究。
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