Boehringer Ingelheim Receives Approval for JASCAYD® in Progressive Pulmonary Fibrosis
Monday, December 22, 2025
Boehringer Ingelheim has received approval from the U.S. Food and Drug Administration (FDA) for JASCAYD® (nerandomilast) tablets for the treatment of progressive pulmonary fibrosis (PPF) in adults, marking a new treatment option for patients with this serious and progressive lung disease in the United States.
Progressive pulmonary fibrosis affects up to 5.6 million people worldwide and around 100,000 people in the U.S. The condition can result from several forms of ILD, environmental exposures such as asbestos or silica, or unknown causes. Diagnosis is often delayed, and many patients remain untreated despite ongoing disease progression.
Nerandomilast is the first preferential phosphodiesterase 4B (PDE4B) inhibitor approved for PPF. It has immunomodulatory and antifibrotic effects designed to slow the progression of lung scarring. The FDA decision was based on results from the Phase III FIBRONEER™-ILD trial, the largest clinical trial programme conducted in PPF to date.
In the study, the primary endpoint was the change from baseline in forced vital capacity (FVC), a key measure of lung function, at 52 weeks. Patients treated with nerandomilast showed a significantly smaller decline in FVC compared with those receiving placebo. The adjusted mean decline in FVC was lower in both the 18 mg and 9 mg dose groups than in the placebo group, demonstrating that the drug slowed lung function loss over one year.
Secondary analyses from the FIBRONEER™-ILD trial assessed time to acute ILD exacerbation, hospitalisation for respiratory causes, or death. While the overall composite endpoint did not reach statistical significance, exploratory analyses suggested a reduction in the risk of acute ILD exacerbations with the 18 mg dose. A numerical reduction in respiratory-related hospitalisations was also observed. In addition, survival trends favoured nerandomilast, although these results were not adjusted for multiplicity.
Overall, nerandomilast was well tolerated. The safety profile was generally consistent with that seen in idiopathic pulmonary fibrosis. Diarrhoea was the most commonly reported side effect, particularly in patients taking background nintedanib. Most cases were mild to moderate and occurred within the first three months of treatment. Treatment discontinuation due to diarrhoea was uncommon, especially in patients not receiving concomitant antifibrotic therapy. The FDA-approved label does not include a ‘Warnings and Precautions’ section.
With this approval, nerandomilast becomes an important new option aimed at slowing lung function decline and improving disease management for adults living with progressive pulmonary fibrosis.
Source: boehringer-ingelheim.com
