Nerandomilast modelling predicts multi-year survival gain in IPF
Boehringer Ingelheim has presented long-term survival modelling suggesting its oral PDE4B inhibitor nerandomilast could extend median survival by up to 5.4 years in adults with idiopathic pulmonary fibrosis (IPF) and up to 3.3 years in those with progressive pulmonary fibrosis (PPF), compared with no therapy. The analyses were delivered as posters at the American Thoracic Society (ATS) 2026 and EULAR 2026 congresses in June.
The modelling is derived from the Phase III FIBRONEER-IPF and FIBRONEER-ILD trials, which met their primary endpoint of slowing forced vital capacity (FVC) decline over 52 weeks versus placebo. A key secondary endpoint covering acute exacerbations, respiratory hospitalisation and death was not met in either trial, though a pooled FIBRONEER analysis presented at ERS 2025 reported a 59% nominally significant reduction in the risk of death with nerandomilast 18 mg monotherapy compared with placebo.
The numbers in detail
In the IPF cohort, nerandomilast 18 mg monotherapy is projected to extend median survival from 3.7 years with no therapy to 9.1 years. For patients already on nintedanib as background treatment, adding nerandomilast is predicted to push median survival from 4.6 years to 6.0 years. In PPF, monotherapy is modelled to extend survival from 3.9 years to 7.2 years, while the nintedanib add-on scenario shifts the projection from 3.4 years to 4.4 years.
Boehringer has been transparent that these figures represent Weibull distribution modelled projections over a 30-year horizon, not observed outcomes from the trials themselves. The company says the ongoing open-label extension study FIBRONEER-ON, together with emerging real-world data, will provide longer-term observational evidence.
Toby Maher, Professor of Clinical Medicine at the Keck School of Medicine, USC Los Angeles, said nerandomilast may have "an effect on survival beyond that mediated by reducing decline in FVC," pointing to trial data that show improvements he described as "truly meaningful."
Market context and regulatory outlook
Nerandomilast, marketed as JASCAYD, is already approved in the US, China, Japan and the UAE for both IPF and PPF. In Europe, the Committee for Medicinal Products for Human Use issued a positive opinion in May 2026, and a regulatory submission is under review by the MHRA in the UK. Further approvals are anticipated before year-end.
The fibrotic lung disease market is currently dominated by two antifibrotics, pirfenidone and nintedanib, both of which carry tolerability challenges that limit long-term adherence. Lykke Hinsch Gylvin, Chief Medical Officer at Boehringer Ingelheim, framed nerandomilast's tolerability profile as central to realising its survival potential, noting that patients who abandon therapy cannot benefit from sustained treatment effects.
Nerandomilast's approval in two indication areas, and its positioning as a nintedanib add-on as well as a monotherapy, gives Boehringer a potentially broad commercial footprint in a disease area affecting an estimated 9.2 million people globally. The company is also running exploratory programmes in systemic sclerosis and myositis, conditions that share fibrotic pathology with PPF and could expand the addressable patient population further.
Survival modelling of this kind is becoming more common as regulators and payers demand longer-horizon data than finite-duration trials can supply. The FIBRONEER-ON extension will be the critical test of whether the projected gains translate into observed benefit in a real-world adherent population.