FDA
Jascayd OK’d for progressive pulmonary fibrosis
On December 19, 2025, FDA expanded the approval of Jascayd (nerandomilast), an oral phosphodiesterase inhibitor, to include treatment of progressive pulmonary fibrosis (PPF) in adults.
Efficacy
Approval was based on data from the phase 3 FIBRONEER-ILD trial (NCT05321082), where the primary endpoint was the absolute change from baseline in forced vital capacity (FVC) in mL at week 52. Jascayd demonstrated a significantly smaller reduction in FVC decline from baseline compared with placebo. The adjusted mean decline in absolute change from baseline in FVC in patients receiving Jascayd 18 mg or 9 mg was -86 mL and -69 mL, respectively, vs. -152 mL in the placebo group. The respective treatment difference compared with the placebo group was 65 mL (95% confidence interval [CI], 30-101) and 83 mL (95% CI, 48-118).
Safety
The most common adverse reactions in patients with PPF treated with Jascayd were generally consistent with those observed in patients with IPF.
Sources:
Jascayd (nerandomilast) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/220449s000lbl.pdf Revised December 2025. Accessed December 22, 2025.
US FDA approves Jascayd® (nerandomilast) tablets for the treatment of progressive pulmonary fibrosis in adults. [News release]. 2025. https://www.boehringer-ingelheim.com/human-health/lung-diseases/pulmonary-fibrosis/us-fda-approves-jascayd-nerandomilast-progressive-pulmonary-fibrosis