FDA

Jascayd approved for idiopathic pulmonary fibrosis

October 14, 2025

Brand name: Jascayd

Generic name: nerandomilast

Manufacturer: Boehringer Ingelheim

Approval date: October 7, 2025

FDA has approved Jascayd (nerandomilast) to treat idiopathic pulmonary fibrosis (IPF). This is the first new therapy approved in more than 10 years for IPF.

Efficacy

Approval was based on data from two clinical trials: FIBRONEER-IPF (NCT05321069) and Trial 2 (NCT04419506). Primary endpoint in FIBRONEER-IPF was absolute change from baseline in Forced Vital Capacity (FVC) at week 52. Nerandomilast demonstrated a significantly smaller FVC decline vs. placebo. Specifically, the adjusted mean decline in patients receiving 18 mg or 9 mg nerandomilast was -106 mL and -122 mL, respectively, vs. -170 mL in the placebo group. Additionally, a treatment effect was shown as early as week two with nerandomilast 18 mg compared with placebo, with changes from baseline in FVC continuing to diverge over time to week 52.

Safety

The most common side effects (≥5%) in clinical trials were diarrhea, COVID-19, upper respiratory tract infection, depression, weight decreased, decreased appetite, nausea, fatigue, headache, vomiting, back pain, and dizziness.

Sources:

FDA approves drug to treat idiopathic pulmonary fibrosis. [News release]. 2025. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-drug-treat-idiopathic-pulmonary-fibrosis

Jascayd (nerandomilast) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218764s000lbl.pdf Revised October 2025. Accessed October 10, 2025.

U.S. FDA approved Boehringer’s JASCAYD® (nerandomilast tablets) as first new treatment options for adults with IPF in over a decade. [News release]. 2025. https://www.boehringer-ingelheim.com/human-health/lung-diseases/pulmonary-fibrosis/fda-approves-jascayd-nerandomilast-first-new-treatment-ipf-over-decade