Nerandomilast Could Reduce Progressive Pulmonary Fibrosis: Study

A total of 1176 patients had at least one dosage of nerandomilast or placebo. At the start of the study, 43.5% of them were already receiving nintedanib as part of their regular treatment. In the nerandomilast 18-mg group, the adjusted mean change in the FVC at week 52 was -98.6 ml (95% CI, -123.7 to -73.4), in the nerandomilast 9-mg group, -84.6 ml (95% CI, -109.6 to -59.7), and in the placebo group, -165.8 ml (95% CI, -190.5 to -141.0).

There was an adjusted difference of 67.2 ml (95% CI, 31.9 to 102.5; P<0.001) between the nerandomilast 18-mg and placebo groups, and 81.1 ml (95% CI, 46.0 to 116.3; P<0.001) between the nerandomilast 9-mg and placebo groups. As reported by 36.6% of patients in the nerandomilast 18-mg group, 29.5% of patients in the nerandomilast 9-mg group, and 24.7% of patients in the placebo group, diarrhea was the most common side event.

In the study groups, comparable proportions of patients experienced serious adverse events. Overall, over a 52-week period, nerandomilast therapy resulted in a lower drop in the FVC than placebo in individuals with progressive pulmonary fibrosis.

Source:

Maher, T. M., Assassi, S., Azuma, A., Cottin, V., Hoffmann-Vold, A.-M., Kreuter, M., Oldham, J. M., Richeldi, L., Valenzuela, C., Wijsenbeek, M. S., Clerisme-Beaty, E., Coeck, C., Gu, H., Ritter, I., Schlosser, A., Stowasser, S., Voss, F., Weimann, G., Zoz, D. F., … FIBRONEER-ILD Trial Investigators. (2025). Nerandomilast in patients with progressive pulmonary fibrosis. The New England Journal of Medicine, 392(22), 2203–2214. https://doi.org/10.1056/NEJMoa2503643