Nerandomilast Nets First New FDA Approval for Idiopathic Pulmonary Fibrosis in Over 10 Years

The United States Food and Drug Administration (FDA) has approved nerandomilast 9 mg and 18 mg tablets, to be marketed as Jascayd (Boehringer Ingelheim) for the treatment of adults with idiopathic pulmonary fibrosis (IPF), marking the first new approval for the disease in over 10 years.1,2

Nerandomilast is an oral, preferential inhibitor of phosphodiesterase 4B (PDE4B). It previously demonstrated safety and efficacy in people with IPF in late breaking data from the phase 3 randomized, double-blind, placebo-controlled FIBRONEER-IPF study presented at the American Thoracic Society (ATS) International Conference in San Francisco in May, alongside other positive data in progressive pulmonary fibrosis (PPF) from the FIBRONEER-ILD study.3

In FIBRONEER-IPF, 1177 patients were randomized 1:1:1 to receive nerandomilast at 9 mg twice daily, nerandomilast at 18 mg twice daily, or a placebo twice daily until the last patient received treatment for 52 weeks. The blinded trial duration was up to 91 weeks, and the end of trial duration was up to 109 weeks. Patients receiving nerandomilast had significantly less decline in absolute change from baseline in forced vital capacity (FVC) in milliliters (mL) than those who received placebo. In the nerandomilast cohorts, the adjusted mean decline in FVC was –106 mL in the 18-mg group and –122 mL in the 9-mg group. In the placebo group, the adjusted mean decline was –170 mL. The drug was well-tolerated, with participatants discontinuing due to adverse events at a 14.0% rate in the 18 mg group, 11.7% in the 9 mg, and 10.7% in the placebo arm.3

"After several challenges in the scientific community to bring forward new clinical data, IPF and PPF continue to take a devastating toll on patients,” FIBRONEER-IPF investigator Toby Maher, MD, PhD, professor of Clinical Medicine at USC’s Keck School of Medicine said in a statement.3 “Having 2 phase III trials meet the primary endpoint is a major breakthrough for the scientific community, highlighting nerandomilast’s potential to have a meaningful impact on patients’ unmet needs, being studied as mono therapy or in combination with current treatments.”

The new IPF approval was also supported by data from a phase 2 trial including 147 patients with or without previous antifibrotic treatments (nintedanib or pirfenidone) randomized 2:1 to receive either nerandomilast at 18 mg twice daily or a twice-daily placebo for 12 weeks. Patients taking nerandomilast experienced a 91 mL decline in FVC at 12 weeks (95% CI, 44-138).4

References

1. Drugs@FDA: FDA-approved drugs. accessdata.fda.gov. Accessed October 7, 2025. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218764

2. FDA approves drug to treat idiopathic pulmonary fibrosis. FDA. News release. October 7, 2025. Accessed October 7, 2025. https://content.govdelivery.com/accounts/USFDA/bulletins/3f61959

3. Global phase III trials demonstrate that nerandomilast slowed lung function decline in IPF and PPF, with similar discontinuation rates to placebo. Boehringer Ingelheim. May 19, 2025. Accessed May 19, 2025. https://www.boehringer-ingelheim.com/human-health/lung-diseases/pulmonary-fibrosis/phase-3-trials-nerandomilast-slowed-lung-function-decline-ipf-and-ppf.

4. Jascayd. Prescribing information. FDA; 2025. Accessed October 7, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218764s000lbl.pdf