Boehringer Ingelheim’s nerandomilast (JASCAYD®) shows model‑based survival gains of up to 5.4 years in idiopathic pulmonary fibrosis and 3.3 years in progressive pulmonary fibrosis, based on Phase 3 FIBRONEER data presented at ATS and EULAR 2026.
Written By: Meghana Jinka, PharmD
Reviewed By: Pharmacally Editorial Team
Boehringer Ingelheim has reported new long-term survival modeling data suggesting that nerandomilast, an oral preferential phosphodiesterase 4B (PDE4B) inhibitor, could significantly improve survival in adults with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). The analyses, presented at the American Thoracic Society (ATS) 2026 and European Alliance of Associations for Rheumatology (EULAR) 2026 congresses, were based on Phase 3 FIBRONEER trial data.
The modeling predicts that nerandomilast could extend median survival by up to 5.4 years in IPF and up to 3.3 years in PPF when used as monotherapy compared with no treatment. Additional survival gains were also projected when the therapy was added to background nintedanib treatment.
Scientific and Clinical Context
Nerandomilast is an oral preferential PDE4B inhibitor with antifibrotic, immunomodulatory, and vascular effects. It is approved in the United States, China, Japan, and the United Arab Emirates for adults with IPF and PPF under the brand name JASCAYD®.
IPF and PPF are progressive fibrotic lung diseases marked by irreversible scarring that impairs oxygen transfer and progressively reduces lung function. Despite current therapies, approximately half of patients die within five years of diagnosis, highlighting the need for treatments that can improve long-term outcomes.
Modeling Results and Clinical Evidence
The survival projections were generated using Weibull distribution modeling based on data from the Phase 3 FIBRONEER-IPF (NCT05321069) and FIBRONEER-ILD (NCT05321082) trials, with outcomes extrapolated over 30 years.
In IPF, nerandomilast 18 mg monotherapy was predicted to increase median survival from 3.7 years without treatment to 9.1 years. In patients receiving background nintedanib, adding nerandomilast increased projected median survival from 4.6 years to 6.0 years.
In PPF, nerandomilast monotherapy was projected to extend median survival from 3.9 years to 7.2 years. When combined with nintedanib, median survival increased from 3.4 years to 4.4 years.
The FIBRONEER trials met their primary endpoints, demonstrating significantly slower decline in forced vital capacity (FVC) over 52 weeks compared with placebo in both IPF and PPF populations. Although the key secondary composite endpoint was not achieved, a pooled analysis showed a nominally significant 59% reduction in mortality risk among patients receiving nerandomilast 18 mg monotherapy versus placebo.
Importantly, these survival estimates are model-based projections and not observed long-term clinical outcomes.
Clinical Implications
Professor Toby Maher, Keck School of Medicine at the University of Southern California, noted that slowing FVC decline is widely regarded as a key predictor of improved survival in pulmonary fibrosis. He said the FIBRONEER findings and survival analyses suggest nerandomilast may provide benefits beyond preserving lung function alone.
Dr. Lykke Hinsch Gylvin, Chief Medical Officer and Head of Global Medicine at Boehringer Ingelheim, highlighted the importance of treatment tolerability in chronic fibrotic lung diseases, noting that sustained therapy may help patients realize the long-term benefits projected by the modeling analyses.
Clinical Path Forward
Regulatory reviews of nerandomilast for IPF and PPF remain underway in the European Union, the United Kingdom, and other markets. The European Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion in May 2026, with additional approvals anticipated later this year.
Long-term validation of the survival projections will come from the ongoing open-label extension study, FIBRONEER-ON, and future real-world evidence. Boehringer Ingelheim is also evaluating nerandomilast in systemic sclerosis and idiopathic inflammatory myopathies, potentially expanding its role beyond pulmonary fibrosis.
What This Means for Patients
For people living with IPF or PPF, nerandomilast may offer the potential for longer survival while helping preserve lung function. The modeling suggests median survival could nearly double in IPF and improve substantially in PPF. Although the findings are based on statistical projections rather than observed outcomes, they support the possibility that future therapies may not only slow disease progression but also extend life expectancy.
Reference
FIBRONEER™ trials survival benefit nerandomilast IPF and PPF | Boehringer Ingelheim
About the Writer
Meghana Jinka (LinkedIn) is a Pharm.D graduate with a strong interest in clinical pharmacy, clinical research, pharmacovigilance, and medical writing. She has developed expertise in evaluating scientific literature, interpreting clinical data, and communicating complex medical information in a clear and accessible manner. Through clinical training, patient counseling, and healthcare awareness activities, she has gained practical experience in evidence-based medicine and patient-centered care. Passionate about healthcare communication, Meghana is committed to developing accurate, engaging, and evidence-based healthcare documents that support healthcare professionals and the wider community.