Europe’s drug regulator has moved a step closer to approving Boehringer Ingelheim’s oral antifibrotic for two forms of pulmonary fibrosis. At its 18-21 May 2026 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorisation for nerandomilast (brand name Jascayd).
The recommendation is broad. It covers adults with idiopathic pulmonary fibrosis (IPF) and adults with progressive pulmonary fibrosis (PPF) — two populations where, in the committee’s words, “there are limited treatment options.” A CHMP positive opinion is not itself a marketing authorisation; the European Commission issues the binding decision, typically within about two months.
What the trial showed
The IPF case rests on FIBRONEER-IPF, a phase 3, double-blind trial that randomly assigned 1,177 patients in a 1:1:1 ratio to nerandomilast 18 mg twice daily, nerandomilast 9 mg twice daily, or placebo; 77.7% were already taking nintedanib or pirfenidone. The primary endpoint was the absolute change from baseline in forced vital capacity (FVC) at week 52.
At 52 weeks, the 18-mg dose slowed FVC decline by 68.8 mL versus placebo (95% CI, 30.3 to 107.4; P<0.001).
The 9-mg arm showed a 44.9 mL difference versus placebo (95% CI, 6.4 to 83.3; P=0.02). Both active arms still lost lung function over the 52 weeks — just less than placebo. Diarrhea was the most common adverse event, reported in 41.3% of the 18-mg group and 31.1% of the 9-mg group, versus 16.0% on placebo.
Nerandomilast (BI 1015550) is described in the trial report as an orally administered preferential inhibitor of phosphodiesterase 4B (PDE4B), with antifibrotic and immunomodulatory effects. The report characterises that mechanism as distinct from nintedanib and pirfenidone, the two antifibrotics that have anchored IPF care since the mid-2010s; that comparison is the publication’s editorial framing and was not stated by the regulator.