FDA Approves First New IPF Treatment in More Than a Decade: Daily Dose

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On October 8, 2025, we reported on the FDA approval of nerandomilast 9 mg and 18 mg tablets for the treatment of idiopathic pulmonary fibrosis (IPF) in adults.

The approval

Nerandomilast, to be marketed as Jascayd (Boehringer Ingelheim) is the first new approval for IPF in more than 10 years. The approval was supported by data from the randomized, double-blind, placebo-controlled FIBRONEER-IPF trial and phase 2 trial 2. In FIBRONEER-IPF, 1177 patients were randomized 1:1:1 to receive nerandomilast 9 mg twice daily, nerandomilast 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 endpoint was absolute change from baseline in FVC in milliliters at 52 weeks.

Participants receiving nerandomilast experienced significantly less decline in absolute change from baseline in FVC 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 participants 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.

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