U.S. FDA approves JASCAYD® (nerandomilast) tablets for progressive pulmonary fibrosis in adults
Tuesday, December 23, 2025
Boehringer Ingelheim has received approval from the U.S. Food and Drug Administration (FDA) for JASCAYD® (nerandomilast) tablets to treat adults with progressive pulmonary fibrosis (PPF). The approval provides a new treatment option in the U.S. for this serious lung disease.
JASCAYD is the first approved preferential phosphodiesterase 4B (PDE4B) inhibitor for PPF and is designed to offer immunomodulatory and antifibrotic effects. The FDA decision is based on data from the Phase III FIBRONEER™-ILD clinical trial, the largest clinical trial programme conducted in PPF to date.
Results from the study showed that JASCAYD slowed the decline in lung function compared with placebo. Rates of permanent treatment discontinuation due to adverse events were similar between JASCAYD and placebo groups.
Progressive pulmonary fibrosis is linked to several underlying interstitial lung diseases, including autoimmune-related conditions and hypersensitivity pneumonitis. Lung scarring in these conditions can lead to a steady and irreversible loss of lung function, which can severely affect daily life.
The main study endpoint was the change from baseline in forced vital capacity (FVC), a key measure of lung function, after 52 weeks. Patients treated with JASCAYD showed a smaller reduction in FVC compared with those receiving placebo. The adjusted mean decline in FVC was lower in both JASCAYD dose groups than in the placebo group. The safety profile of JASCAYD in PPF was generally in line with what has been seen in patients with idiopathic pulmonary fibrosis.
The FDA approval marks an important step in addressing the unmet medical need in progressive pulmonary fibrosis and supports access to a new, well-tolerated option aimed at slowing lung function decline in affected adults.
Source: prnewswire.com
