Nerandomilast: First Approval

<b>Funding</b> The preparation of this review was not supported by any external funding.<b>Declarations</b><b>Authorship and Conflict of interest</b> During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Michael B. Brown is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to this article and are responsible for its content.<b>Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability</b> Not applicable.Additional information about this Adis Drug Review can be found <b>here</b>.AbstractNerandomilast (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.© The Author(s), under exclusive licence to Springer Nature Switzerland AG 2026