Effect of nerandomilast on clinical outcomes in patients with idiopathic pulmonary fibrosis (IPF): data from final database lock of the FIBRONEER-IPF trial*

Introduction: The FIBRONEER-IPF trial was a randomised placebo-controlled trial of nerandomilast 9 mg bid and 18 mg bid in patients with IPF. The primary endpoint (change in FVC [mL] over 52 weeks) was met for both doses. Patients continued randomised treatment until the end of the trial. Aim: Assess the effects of nerandomilast on time-to-event endpoints in the FIBRONEER-IPF trial. Methods: Time to first acute exacerbation, hospitalisation for respiratory cause, or death (key secondary endpoint) and other secondary time-to-event endpoints were assessed. Results: 1177 patients received trial medication. Up to final database lock, mean (SD) exposure to trial medication was 14.8 (5.1) months and mean (SD) observation time was 16.4 (3.3) months. FVC curves continued to diverge beyond week 52. Nerandomilast had no effect on the key secondary endpoint or most other time-to-event endpoints ([ Fig. 1 ]). There was a numerical reduction in risk of death with nerandomilast 18 mg bid vs placebo (HR 0.66 [95% CI: 0.41, 1.08]). The risk of decline in FVC% predicted>10% or death was reduced with nerandomilast 18 mg bid vs placebo (HR 0.75 [95% CI: 0.59, 0.95]). Conclusions: In the FIBRONEER-IPF trial, there was a numerically lower risk of death, and of decline in FVC% predicted>10% or death, in patients who received nerandomilast 18 mg bid versus placebo. *previously presented at the European Respiratory Society (ERS) congress 2025 Fig. 1 Publication History Article published online: 04 March 2026 © 2026. Thieme. All rights reserved. Georg Thieme Verlag KG Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany