FDA Approves Jascayd for Idiopathic Pulmonary Fibrosis

TUESDAY, Oct. 14, 2025 (HealthDay News) — The U.S. Food and Drug Administration has approved Jascayd (nerandomilast) tablets to treat idiopathic pulmonary fibrosis (IPF).

This is the first new therapy in more than 10 years to be approved for IPF, according to a statement from the manufacturer. It is also the first and only preferential inhibitor of phosphodiesterase 4B to be approved for this indication. The recommended dose for Jascayd is 18 mg to be taken orally twice a day, but dosage may be reduced for intolerability to 9 mg twice daily, except in patients also taking pirfenidone.

The approval was based on two randomized, double-blind, placebo-controlled trials of adults with IPF. Results showed that the adjusted mean decline in forced vital capacity (FVC) for patients receiving 18 or 9 mg Jascayd was −106 mL and −122 mL, respectively, versus −170 mL in the placebo group. The treatment effect was seen as early as week 2 with Jascayd 18 mg compared with placebo, with changes from baseline in FVC continuing to diverge over time to week 52. The most common side effects (≥5 percent) seen with Jascayd included diarrhea, COVID-19, upper respiratory tract infection, depression, decreased weight and appetite, nausea, fatigue, headache, vomiting, back pain, and dizziness. Discontinuation due to adverse reactions occurred more often with Jascayd (with or without background antifibrotic treatment) 18 mg (15 percent) and 9 mg (12 percent) versus placebo (11 percent).

“Jascayd has proven to slow lung function decline in IPF,” Toby Maher, M.D., Ph.D., from the University of Southern California in Los Angeles, said in a statement. “Jascayd is a welcome new treatment option with a well-tolerated safety profile for physicians to consider for appropriate patients.”

Approval of Jascayd was granted to Boehringer Ingelheim.

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