Boehringer Ingelheim’s Nerandomilast Achieves Second Phase III Success in Pulmonary Fibrosis Treatment

Boehringer Ingelheim's experimental drug nerandomilast met its primary endpoint in the Phase III FIBRONEER-ILD trial for progressive pulmonary fibrosis (PPF)14.

The primary endpoint was the absolute change from baseline in forced vital capacity (FVC) at week 52 versus placebo, which is a measure of lung function46.

This success follows a previous Phase III win (FIBRONEER-IPF trial) for nerandomilast in idiopathic pulmonary fibrosis (IPF) reported in September 202424.

Nerandomilast is an investigational oral, preferential inhibitor of phosphodiesterase 4B (PDE4B)46.

Boehringer Ingelheim plans to submit a new drug application (NDA) for nerandomilast to the FDA and other health authorities for approval in patients with PPF4.

The FIBRONEER-ILD trial enrolled 1,178 adult patients and allowed concomitant use of Ofev (nintedanib), another Boehringer Ingelheim drug4.

Full efficacy and safety data from the FIBRONEER-ILD trial will be shared in the second quarter of 20256.

Nerandomilast was granted FDA Breakthrough Therapy Designation for the treatment of IPF in February 20226.

If approved, nerandomilast could potentially succeed Ofev in Boehringer Ingelheim's lung disease portfolio4.

Sources:

1. https://endpts.com/boehringer-ingelheim-touts-success-in-second-phase-3-lung-fibrosis-trial/

2. https://www.fiercebiotech.com/biotech/boehringers-phase-3-lung-fibrosis-trial-hits-primary-endpoint-teeing-filings-ofev-successor

4. https://www.clinicaltrialsarena.com/news/nerandomilast-phaseiii-success-ppf-seeks-approval/

6. https://www.globenewswire.com/news-release/2025/02/10/3023409/0/en/Boehringer-s-nerandomilast-meets-primary-endpoint-in-Phase-III-study-FIBRONEER-ILD-in-progressive-pulmonary-fibrosis.html