Safety and tolerability of nerandomilast in patients with pulmonary fibrosis: pooled data from the FIBRONEER-IPF and FIBRONEER-ILD trials*

Introduction: Two phase 3 trials evaluated nerandomilast 9 mg bid and 18 mg bid in patients with IPF (FIBRONEER-IPF) and other forms of progressive pulmonary fibrosis (PPF) (FIBRONEER-ILD). Aim: Assess the safety and tolerability of nerandomilast in patients with IPF or PPF. Methods: Data up to final database locks in the FIBRONEER-IPF and FIBRONEER-ILD trials were pooled. Results: 2353 patients received≥1 dose of trial drug. Mean exposure to trial drug was 15.0 months and mean observation time was 16.7 months. The most frequent adverse event was diarrhoea, but this infrequently led to treatment discontinuation, especially in patients not taking background nintedanib or pirfenidone ([ Fig. 1 ]). There were fewer serious adverse events in the nerandomilast groups than in the placebo group, and a similar frequency of adverse events leading to discontinuation of trial drug between the nerandomilast and placebo groups. Fatal adverse events occurred in lower proportions of patients in the nerandomilast groups than in the placebo group. Conclusions: Pooled data from the FIBRONEER trials show that nerandomilast has a favourable safety and tolerability profile in patients with pulmonary fibrosis, with a similar rate of discontinuation due to adverse events as placebo. *previously presented at the European Respiratory Society (ERS) congress 2025; The presenting author is presenting on behalf of the authors 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