India Pharma Outlook Team | Wednesday, 01 October 2025
Boehringer Ingelheim has revealed data from the global Phase III FIBRONEER program series studying nerandomilast, a PDE4B inhibitor that orally preferentially blocks the activity of the PDE4B enzyme, which is currently awaiting approval.
This announcement was made at the 2025 European Respiratory Society (ERS) International Congress, held in Amsterdam. The combined data analyses derived from FIBRONEER-IPF and FIBRONEER-ILD, showed a reduction in the risk of death (nominally statistically significant) in patients with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF).
The time to the first acute exacerbation, respiratory cause hospitalization, or death was not attained; the combined analysis exhibited the risk of death being reduced by 43% for the 18 mg nerandomilast dose compared to placebo.
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The effect was stronger with monotherapy, where the risk reduction was 59%. The safety of nerandomilast was pleasant, and the number of adverse events leading to discontinuation was comparable with the placebo group.
Diarrhea was the most frequent adverse event, reported in 27.4% of treated patients with nerandomilast 18 mg without background therapy. These results reveal that nerandomilast is likely to be one of the main therapies in the field of IPF and PPF.
The Food and Drug Administration (FDA) in the US has given Breakthrough Therapy Designation to nerandomilast in IPF and PPP with expected decision dates in the fourth quarter of 2025. Applications for approval are currently being assessed in China, the United Kingdom, and the European Union.
