Nerandomilast

Phase 3 FIBRONEER-IPF trial met primary endpoint with nerandomilast in adults with IPF, showing absolute change in FVC. Boehringer Ingelheim plans to submit a new drug application to the FDA and present full findings in early 2025.

Boehringer Ingelheim seeks approval for nerandomilast after Phase III trial in idiopathic pulmonary fibrosis met primary endpoint. The trial, FIBRONEER-IPF, improved forced vital capacity after 52 weeks. Nerandomilast, a PDE4B inhibitor, received breakthrough therapy designation in 2022 and is also being tested in progressive fibrosing interstitial lung diseases.

Boehringer Ingelheim's nerandomilast met primary endpoint in phase 3 trial for idiopathic pulmonary fibrosis (IPF), marking the first successful IPF phase-3 trial in a decade. The oral drug, a preferential inhibitor of phosphodiesterase 4B, received FDA breakthrough therapy designation in 2022. Boehringer plans to submit a new drug application to the FDA and other regulators based on these positive results.

FIBRONEER™-IPF trial met primary endpoint: absolute change in Forced Vital Capacity at week 52. Boehringer Ingelheim to submit nerandomilast for IPF treatment to FDA and other Health Authorities worldwide.