Europe gives nod to Boehringer’s Jascayd as first new oral IPF drug in over a decade

Edited by Robert McTiernan··2 min read

The European Commission has granted marketing authorization for Jascayd (nerandomilast), Boehringer Ingelheim’s oral treatment for idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF), as per a company release. The approval represents the first new IPF treatment authorized in the EU in over a decade and the first for PPF in more than five years, and it establishes nerandomilast as the first oral, preferential phosphodiesterase 4B (PDE4B) inhibitor cleared in the bloc for either indication.

The approved regimen is a twice-daily oral tablet for adults with IPF and adults with PPF, two progressive fibrosing lung diseases with no cure and a five-year mortality rate the company says exceeds that of many cancers. Notably, the label carries no requirement for liver monitoring, a practical distinction from some existing antifibrotics.

Approval rests on the Phase III FIBRONEER-IPF and FIBRONEER-ILD trials, described by the company as the largest clinical program conducted to date in these conditions. Both studies met their primary endpoint, showing that nerandomilast slowed decline in forced vital capacity from baseline to week 52 versus placebo; a key secondary endpoint covering exacerbations, hospitalization, or death was not met in either trial, though a numerical mortality reduction was observed in both and reached nominal significance in FIBRONEER-ILD. This positions nerandomilast within an IPF pipeline that includes Insilico Medicine’s TNIK inhibitor rentosertib, whose ongoing Phase III program explicitly uses the FIBRONEER trial structure as a design benchmark.

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Mechanistically, nerandomilast inhibits PDE4B with greater isoform selectivity than earlier nonselective PDE4 inhibitors such as roflumilast, raising intracellular cAMP levels to dampen fibroblast-to-myofibroblast transition and matrix deposition while aiming to limit the gastrointestinal side effects that have historically limited PDE4-directed therapy. In the FIBRONEER trials, monotherapy discontinuation rates were similar to placebo, a tolerability profile the company and outside investigators, including Erasmus MC’s Marlies Wijsenbeek, have framed as a meaningful departure from existing antifibrotics.

Nerandomilast enters a market long dominated by nintedanib (Ofev), Boehringer’s own triple angiokinase inhibitor, and Roche’s pirfenidone (Esbriet), which is approved for IPF but not PPF in the EU. Its arrival also comes as competitive pressure builds elsewhere in the pipeline: Bristol Myers Squibb’s LPA1 inhibitor admilparant is advancing through Phase III trials in both IPF and PPF, with readouts expected in 2026–2027, while Celea’s deupirfenidone is being tested in a head-to-head superiority trial against standard-of-care agents. Nerandomilast is already authorized in the United States, China, Japan, the UK, Brazil and elsewhere, with additional regulatory decisions anticipated through 2026, and Boehringer is also studying the compound in systemic sclerosis and myositis.

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