FDA Approves Nerandomilast for Idiopathic Pulmonary Fibrosis

The FDA has approved nerandomilast (Jascayd; Boehringer Ingelheim) for the treatment of adults with idiopathic pulmonary fibrosis (IPF).¹

Data from the randomized, placebo-controlled, double-blind FIBRONEER-IPF trial (NCT05321069) and from Trial 2 (NCT04419506) supported the approval,² which is the first in more than a decade for IPF.³ The phosphodiesterase 4 inhibitor was found to slow lung function decline compared with placebo in the study, which included 1177 patients.²

In FIBRONEER-IPF, 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. The primary end point was absolute change from baseline in forced vital capacity
(FVC) in milliliters (mL) at 52 weeks.

The trial showed significantly less decline in absolute FVC from baseline among patients who received nerandomilast vs 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.

In Trial 2, 147 patients with IPF with or without previous antifibrotic treatments (nintedanib or pirfenidone) were 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).

The most common adverse reactions associated with nerandomilast were diarrhea, COVID-19, upper respiratory tract infection, depression, decreased weight, decreased appetite, nausea, fatigue, headache, vomiting, back pain, and dizziness. Diarrhea was most commonly associated with treatment discontinuation.

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

3. 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