Nerandomilast & Pulmonary Fibrosis: New Hope?
- A recent phase 3 clinical trial suggests that nerandomilast, a phosphodiesterase 4B inhibitor, can effectively slow the progression of pulmonary fibrosis in adults.The study, conducted across 44 countries,...
- Maher at the University of Southern California,involved 1,176 participants with a mean age of 66.4 years.
- Results indicated that both the 18 mg and 9 mg doses of nerandomilast substantially reduced the decline in FVC compared to the placebo.
nerandomilast emerges as a potential game-changer in the fight against pulmonary fibrosis. A recent phase 3 trial highlights this promising drug’s ability to slow disease progression in adults suffering from interstitial lung diseases (ILDs). The study revealed notable benefits with both 18 mg and 9 mg doses, administered twice daily. The research, conducted across multiple countries, demonstrates a significant reduction in the decline of forced vital capacity (FVC), providing new hope for those with progressive pulmonary fibrosis.Diarrhea was the moast prevalent side effect reported.This development, covered by News Directory 3, marks a notable advancement in treatments beyond idiopathic pulmonary fibrosis (IPF). Dive in for an in-depth look at the results and what they mean for patients. Discover what’s next …
Nerandomilast Shows Promise in Treating Pulmonary Fibrosis
Updated June 26, 2025
A recent phase 3 clinical trial suggests that nerandomilast, a phosphodiesterase 4B inhibitor, can effectively slow the progression of pulmonary fibrosis in adults.The study, conducted across 44 countries, focused on patients with progressive pulmonary fibrosis resulting from interstitial lung diseases (ILDs) other than idiopathic pulmonary fibrosis.
The trial, led by Dr. Toby M. Maher at the University of Southern California,involved 1,176 participants with a mean age of 66.4 years. Participants were randomly assigned to receive either 18 mg or 9 mg of nerandomilast, or a placebo, twice daily.The study, which was funded by Boehringer Ingelheim, stratified patients based on nintedanib therapy and fibrotic patterns observed via CT scans. The primary endpoint was the change in forced vital capacity (FVC) at week 52.
Results indicated that both the 18 mg and 9 mg doses of nerandomilast substantially reduced the decline in FVC compared to the placebo. Specifically, adjusted differences were 67.2 mL for the 18 mg dose and 81.1 mL for the 9 mg dose (P < .001 for both). This benefit was observed nonetheless of weather patients were also receiving nintedanib therapy. While the study didn't confirm a reduction in acute exacerbations, respiratory-related hospitalizations, or death, a lower proportion of deaths occurred in the nerandomilast groups.
Diarrhea was the most frequently reported adverse event,occurring in 36.6% of patients taking 18 mg of nerandomilast, 29.5% taking 9 mg,and 24.7% in the placebo group. Rates of regimen interruption or discontinuation due to adverse events were similar across all groups.
“The FIBRONEER-ILD trial showed that nerandomilast at a dose of 18 mg twice daily or 9 mg twice daily slowed the progression of pulmonary fibrosis in patients with progressive pulmonary fibrosis,” the authors wrote.
An editorial accompanying the study highlighted the potential impact of thes findings. “The current clinical trials represent a meaningful advancement in the treatment landscape for persons living with IPF [idiopathic pulmonary fibrosis] and progressive ILD other than IPF,” the editorial stated.
What’s next
further research is needed to evaluate the effectiveness of nerandomilast in specific ILD subgroups, as the trial excluded patients taking certain medications commonly used for autoimmune diseases. However, these findings represent a notable step forward in addressing pulmonary fibrosis and improving outcomes for affected individuals.