Interstitial lung disease · Antifibrotics beyond IPF
Nerandomilast in Patients with Progressive Pulmonary Fibrosis
| Design | Phase 3, double-blind, placebo-controlled RCT with two doses |
|---|---|
| Treatment | Nerandomilast 18 mg or 9 mg twice daily |
| Control | Placebo |
| Population | 1176 patients with progressive pulmonary fibrosis, 43.5% on background nintedanib |
| Follow-up | 52 weeks |
| Primary endpoint | Absolute change from baseline in FVC at week 52 |
| Result | FVC change -98.6 mL (95% CI -123.7 to -73.4) with 18 mg, -84.6 mL (-109.6 to -59.7) with 9 mg and -165.8 mL (-190.5 to -141.0) with placebo. Adjusted differences 67.2 mL (31.9 to 102.5, p<0.001) and 81.1 mL (46.0 to 116.3, p<0.001) respectively. |
| Secondary endpoints | Acute exacerbation, hospitalisation, death |
In patients with progressive pulmonary fibrosis, treatment with nerandomilast led to a smaller decline in the FVC than placebo over a period of 52 weeks.
The trial authors, in the published abstract
Does for progressive pulmonary fibrosis what FIBRONEER-IPF did for IPF, on the disease-behaviour enrolment principle established by INBUILD. Notably the 9 mg dose performed at least as well as 18 mg here, which it did not in IPF.
Maher TM, Assassi S, Azuma A, et al. Nerandomilast in Patients with Progressive Pulmonary Fibrosis. N Engl J Med 2025 Jun 12;392(22):2203-2214.