Nerandomilast: First Approval.

IF 14.7 1区医学 Q1 PHARMACOLOGY & PHARMACY

Drugs Pub Date : 2026-04-01 Epub Date: 2026-02-26 DOI:10.1007/s40265-026-02288-z

Michael B Brown

引用次数: 0

Abstract

Nerandomilast (JASCAYD^®) is an oral selective phosphodiesterase (PDE) 4B inhibitor developed by Boehringer Ingelheim Pharmaceuticals, Inc. for the treatment of lung fibrosis. It received its first approval on 7 October 2025 in the USA for the treatment of adults with idiopathic pulmonary fibrosis (IPF). Subsequently, nerandomilast was approved on 22 October 2025 in China for the treatment of adults with IPF, and on 10 and 19 December 2025 for treatment of adults with progressive pulmonary fibrosis (PPF) in China and the USA, respectively. Additional global filings and several phase II and III trials are underway. This article summarizes the milestones in the development of nerandomilast leading to this first approval for IPF.

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Nerandomilast：首次批准。

Nerandomilast （JASCAYD®）是一种口服选择性磷酸二酯酶（PDE） 4B抑制剂，由勃林格殷格翰制药公司开发，用于治疗肺纤维化。它于2025年10月7日在美国首次获得批准，用于治疗成人特发性肺纤维化（IPF）。随后，nerandomilast于2025年10月22日在中国被批准用于治疗成人IPF，并于2025年12月10日和19日在中国和美国分别被批准用于治疗成人进行性肺纤维化（PPF）。其他全球申请和几项II期和III期试验正在进行中。本文总结了nerandomilast首次获批IPF的发展里程碑。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Drugs 医学-毒理学

CiteScore

22.70

自引率

0.90%

发文量

134

审稿时长

3-8 weeks

期刊介绍： Drugs is a journal that aims to enhance pharmacotherapy by publishing review and original research articles on key aspects of clinical pharmacology and therapeutics. The journal includes: Leading/current opinion articles providing an overview of contentious or emerging issues. Definitive reviews of drugs and drug classes, and their place in disease management. Therapy in Practice articles including recommendations for specific clinical situations. High-quality, well designed, original clinical research. Adis Drug Evaluations reviewing the properties and place in therapy of both newer and established drugs. AdisInsight Reports summarising development at first global approval. Moreover, the journal offers additional digital features such as animated abstracts, video abstracts, instructional videos, and podcasts to increase visibility and educational value. Plain language summaries accompany articles to assist readers with some knowledge of the field in understanding important medical advances.