Boehringer Ingelheim: EU approval for JASCAYD (nerandomilast) in IPF and PPF

Approval and scope

The European Commission has granted marketing authorisation for JASCAYD (nerandomilast) for the treatment of adults with idiopathic pulmonary fibrosis (IPF) and adults with progressive pulmonary fibrosis (PPF). It is the first new IPF treatment approved in the EU in over a decade and the first PPF approval in more than five years. JASCAYD is a twice‑daily oral, preferential PDE4B inhibitor with antifibrotic and immunomodulatory effects and has already been approved in the United States, China, the United Arab Emirates, Japan, Thailand, the United Kingdom and Brazil.

Clinical evidence

The approval is based on the FIBRONEER Phase III programme, the largest clinical trial programme conducted in IPF and PPF to date. In both FIBRONEER‑IPF and FIBRONEER‑ILD trials the primary endpoint was met: nerandomilast slowed lung function decline measured by absolute change in forced vital capacity (FVC) from baseline to week 52 versus placebo. The key secondary endpoint (time to first acute IPF/ILD exacerbation, first respiratory hospitalisation, or death) was not met, though a numerical reduction in mortality was observed across both trials and reached nominal significance in FIBRONEER‑ILD.

Safety, tolerability and next steps

Nerandomilast demonstrated a favourable safety and tolerability profile in trials, including no requirement for liver monitoring and monotherapy discontinuation rates similar to placebo. Regulatory submissions are under review in other countries with additional approvals anticipated in 2026, and Boehringer Ingelheim is exploring nerandomilast in systemic sclerosis and idiopathic inflammatory myopathies (myositis).