New analyses from FIBRONEER trials suggest survival benefit with nerandomilast in IPF and PPF – Boehringer Ingelheim

Long-term survival modeling of Boehringer Ingelheim’s oral preferential PDE4B inhibitor, nerandomilast, predicts the therapy could extend survival by up to 5.4 years in adults with idiopathic pulmonary fibrosis (IPF) and up to 3.3 years in adults with progressive pulmonary fibrosis (PPF), compared with no therapy. These findings are based on data from the Phase III FIBRONEER trials and were recently presented at the ATS and EULAR 2026 international congresses.

“I expect that nerandomilast will offer a transformative survival benefit for patients with either IPF or PPF,” said Toby Maher, M.D., Ph.D., Professor of Clinical Medicine, Keck School of Medicine, USC Los Angeles. “In clinical practice, we believe that slowing FVC decline is one important precursor to improving survival in people with IPF and PPF. Data from the FIBRONEER trials, plus the survival modeling, are showing us improvements that are truly meaningful, suggesting nerandomilast may have an effect on survival beyond that mediated by reducing decline in FVC.“

In patients with IPF, it is estimated that nerandomilast 18 mg monotherapy could more than double median survival to 9.1 years, extending it from 3.7 years with no therapy. For those receiving standard background therapy with nintedanib, adding nerandomilast 18 mg is predicted to increase median survival from 4.6 years to 6.0 years.  

In patients with PPF, it is predicted that nerandomilast 18 mg monotherapy could extend median survival to 7.2 years compared to 3.9 years with no therapy. When added to background nintedanib, predicted median survival is extended from 3.4 years to 4.4 years.

“IPF and PPF are devastating, life-threatening diseases that ruthlessly steal time from patients. Historically, burdensome side effects have forced many to abandon therapy limiting the potential for a sustained treatment effect,” said Dr. Lykke Hinsch Gylvin, Chief Medical Officer and Head of Global Medicine at Boehringer Ingelheim. “Nerandomilast represents a meaningful step forward. By offering an effective and safe therapy that patients can actually tolerate, it supports sustained, long-term treatment.  If patients are able to stay on therapy longer, nerandomilast may have the potential to translate its predicted survival benefit into what really matters: more precious time with family and loved ones.”

In FIBRONEER-IPF and FIBRONEER-ILD nerandomilast met its primary endpoint, demonstrating slowed lung function decline compared to placebo as measured by the absolute change in Forced Vital Capacity (FVC) from baseline to week 52 in IPF and PPF, respectively. While the key secondary endpoint* was not met in either FIBRONEER-trial, in a pooled analysis of FIBRONEER-trials, a 59% nominally significant reduction in the risk of death was observed in participants treated with nerandomilast 18 mg as monotherapy compared with placebo.

*The key secondary endpoint was time to first acute IPF/ILD exacerbation, first hospitalization for respiratory cause, or death over the duration of trial

About the survival modeling analysis 

The survival benefits were estimated using a statistical model based on data from the FIBRONEER-IPF and FIBRONEER-ILD trials. Researchers used a standard method (Weibull distribution modeling) to estimate long-term survival outcomes over a 30-year period, assuming consistent treatment effects and discontinuation rates similar to those seen during the respective trials.

It is important to note that these figures represent modeled projections, not observed patient outcomes from the clinical trials. Data from the open-label extension of the FIBRONEER trials, FIBRONEER-ON, and real-world evidence will provide further evidence into the long-term effect of nerandomilast.      

Citations: Pimple et al.  Predicting long-term survival benefit of nerandomilast in patients with idiopathic pulmonary fibrosis (IPF). (Poster presented at ATS 2026)

Maher et al. Predicting long-term survival benefit of nerandomilast in patients with progressive pulmonary fibrosis (PPF). (Poster presented at EULAR 2026