News|Articles|May 19, 2026

Nerandomilast Slowed FVC Decline, Improved Median Survival in Patients With IPF

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Key Takeaways

Parametric survival modeling from FIBRONEER-IPF projected median survival of 3.7 years on placebo versus 5.8 and 9.1 years with nerandomilast 9 mg and 18 mg monotherapy.
Background nintedanib attenuated projected survival gains, with median survival 4.6 years on placebo versus 5.1 and 6.0 years with nerandomilast 9 mg and 18 mg.
Pooled US analyses showed smaller 52-week FVC declines with nerandomilast versus placebo despite substantial concurrent antifibrotic use (nintedanib 184 patients; pirfenidone 59 patients).
Composite worsening events decreased dose-dependently (35.0% placebo; 27.2% 9 mg; 20.8% 18 mg), alongside lower mortality (15.8%, 12.3%, 6.9%) and discontinuation rates.

Poster data show the efficacy of nerandomilast in patients with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis.

Patients with either idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) saw promising results when taking nerandomilast to treat their condition. Patients taking the drug consistently saw an increase in median survival and a slowed decrease in forced vital capacity (FVC), according to posters presented during the American Thoracic Society 2026 International Conference.^1,2

Nerandomilast Extends Median Survival in IPF

An increase in median survival was found in the first study that evaluated patients with IPF exclusively.¹ The FIBRONEER-IPF trial had previously found that patients using either 9 mg or 18 mg of monotherapy nerandomilast saw benefits in the risk of death when compared with placebo (HR, 0.56; 95% CI, 0.21-0.49 and HR, 0.26; 95% CI, 0.07-0.91, respectively). The study presented through the poster aimed to estimate the effect of nerandomilast on long-term survival by using a parametric survival model.

There were 7 parametric models that were fit to survival data based on patients not taking antifibrotic therapies like nintedanib or pirfenidone and patients taking background nintedanib in the FIBRONEER-IPF trial. Survival data over 30 years were included, with the US general population acting as the reference population.

The median survival for patients not taking background antifibrotic therapy was 3.7 years in the placebo group, 5.8 years in those taking 9 mg of nerandomilast, and 9.1 years in those taking 18 mg. Patients who took background nintedanib had a median survival of 4.6 years in the placebo group, 5.1 years in the 9 mg group, and 6.0 years in the 18 mg group.

The authors concluded that patients had a 2.5-fold increase in median survival when treated with nerandomilast 18 mg monotherapy compared with placebo. Patients also had a 1.3-fold increase in median survival when treated with nerandomilast 18 mg monotherapy in combination with nintedanib when compared with nintedanib alone. Further studies, including real-world studies, will need to be performed to confirm these findings.

Slowing FVC Decline Across IPF and PPF in US Patients

Nerndomilast also had a significant effect on the decline in FVC in patients from the US with IPF and PPF, according to a separate poster presented at the conference.² The researchers of this study pooled the data from the FIBRONEER-IPF and FIBRONEER-ILD trials to evaluate the effect of nerandomilast on the decline in FVC in the US patients in the trials.

The researchers used the data to assess how FVC changed from baseline to week 52, including time to hospitalization, time to first acute exacerbation of interstitial lung disease, and death through the end of the trial. Any adverse events were reported.

There were 335 patients from the previous trials who were from the US, of which 120 were in the placebo group, 114 were in the 9 mg group, and 101 were in the 18 mg group. A total of 184 and 59 patients also used nintedanib or pirfenidone, respectively. The decline in FVC was smaller in patients who took either dose of nerandomilast when compared with placebo at week 52, with a mean exposure of 15.0 months in the patients from the US.

A total of 35.0% of the placebo group, 27.2% of the nerandomilast 9 mg group, and 20.8% of the 18 mg group had either an acute exacerbation, a hospitalization for a respiratory cause, or a death during the study. A total of 15.8% of the placebo group died during the study compared with 12.3% and 6.9% of the 9 mg and 18 mg groups. Discontinuation occurred for 14.2% of the placebo group, 10.5% of the 9 mg group, and 7.9% of the 18 mg group.

The researchers concluded that nerandomilast was able to slow the decline of FVC and was also able to reduce the risk of several outcomes related to the condition. Both trials prove that nerandomilast has significant benefits to patients in the US who wish to use it for the treatment of IPF and PPF, with further trials needed to confirm these findings.

References

Maher TM, Pimple P, Aronson KI, et al. Predicting long-term survival benefit of nerandomilast in patients with idiopathic pulmonary fibrosis. Presented at American Thoracic Society 2026 International Conference; May 17-20, 2026; Orlando, FL. Abstract 514
Flaherty KR, Zoz DF, Wachtlin D, Orsatti L, Glassberg MK. Effects of nerandomilast in US patients with idiopathic pulmonary fibrosis and progressive pulmonary fibrosis. Presented at American Thoracic Society 2026 International Conference; May 17-20, 2026; Orlando, FL. Abstract 516