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Published on: June 26, 2019
Nerandomilast: First Approval
1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.
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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