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# Boehringer Ingelheim Plans NDA for Lung Disease
- URL: https://www.fdaweb.com/boehringer-ingelheim-plans-nda-for-lung-disease/
- Published: 2025-02-10T12:00:00.000Z
- Updated: 2026-09-14T14:52:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158632

Boehringer Ingelheim says it will submit an NDA for nerandomilast for treating progressive pulmonary fibrosis following the company’s reporting of positive data from its FIBRONEER-ILD trial. The study met its primary endpoint, which was the absolute change from baseline in lung function (forced vital capacity) at week 52 versus placebo. Nerandomilast is described as an investigational oral, preferential inhibitor of phosphodiesterase 4B (PDE4B). It was granted an FDA Breakthrough Therapy Designation for IPF in 2/2022.

The company says initial safety and tolerability results from FIBRONEER show a generally consistent safety profile with Phase 2 results for treating idiopathic pulmonary fibrosis. It says full efficacy and safety data will be shared in the second quarter.