Updated results from FIBRONEER-IPF confirm nerandomilast efficacy over 76 weeks

The FIBRONEER-IPF trial has previously demonstrated that nerandomilast, compared to placebo, significantly improved the slowed decline in forced vital capacity after 52 weeks of treatment in patients with idiopathic pulmonary fibrosis [1]. Prof. Justin Oldham (University of Michigan, MI, USA) presented the extended results from the trial confirming this finding with longer follow-up [2].

FIBRONEER-IPF trial (NCT05321069) was a randomised, controlled, double-blind trial in patients with idiopathic pulmonary fibrosis on a stable dose of nintedanib/pirfenidone for ≥12 weeks or off therapy for ≥8 weeks. Treatment consisted of nerandomilast 9 mg twice daily, 18 mg twice daily, or placebo [1]. The extended analysis reported used the final database lock, which covered 76 weeks of treatment for the 1,177 enrolled participants [2].

The difference between the nerandomilast groups and placebo in terms of the primary endpoint was maintained through Week 76. Secondary endpoints were also reported. However, there were no significant differences between the nerandomilast groups and placebo in terms of acute exacerbations, hospitalisation due to respiratory causes, death, or absolute decline in predicted forced vital capacity, consistent with the primary analysis. Finally, the safety profile was consistent with the initial study.

“In the FIBRONEER-IPF trial, the primary endpoint was achieved and maintained at Week 76”, concluded Prof. Oldham, “but there was no effect on the secondary endpoints. These data support the use of nerandomilast in the treatment of idiopathic pulmonary fibrosis, either as monotherapy or in combination with approved treatments.”

1. Richeldi L, et al. N Engl J Med. 2025;392(22):2193-2202.
2. Oldham J, et al. Effect of nerandomilast on clinical outcomes in patients with idiopathic pulmonary fibrosis (IPF): data from final database lock of the FIBRONEER-IPF trial. ERS Congress, 27 September–1 October 2025, Amsterdam, the Netherlands.

Medical writing support was provided by Mihai Surducan, PhD.

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Posted on 3 October 20253 November 2025