- Long-term survival model results for nerandomilast were presented at the 2026 international congresses of the American Thoracic Society (ATS) and the European Alliance of Associations for Rheumatology (EULAR).
- Based on the model, nerandomilast consistently extended median survival in patients with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF).[1],[2]
- The model predicts that nerandomilast provides meaningful survival extensions, including a median survival increase of several years as monotherapy and additional benefits when used in combination with standard of care.[1],[2]
Ingelheim, GermanyJune 18, 2026 /PRNewswire/ — Long-term survival model results for Boehringer Ingelheim’s oral, highly selective PDE4B inhibitor nerandomilast predict that the therapy can extend survival by up to 5.4 years in adult patients with idiopathic pulmonary fibrosis (IPF) and up to 3.3 years in adult patients with progressive pulmonary fibrosis (PPF), compared to no treatment. [1],[2] These findings are based on data from the FIBRONEER™ Phase III trials and were presented at the 2026 ATS and EULAR international congresses.
“I believe nerandomilast will bring transformative survival benefits to patients with IPF and PPF,” said Toby Maher, M.D., Professor of Clinical Medicine at the Keck School of Medicine of the University of Southern California. “In clinical practice, we consider slowing the decline in FVC (forced vital capacity) as one of the key prerequisites for improving survival in IPF and PPF patients. The FIBRONEER™ clinical trial data and the survival model analysis show us a truly valuable improvement in benefit, suggesting that nerandomilast’s effect on patient survival is not limited to the effect of slowing FVC decline; there is an independent survival benefit beyond FVC improvement.”
In IPF patients, nerandomilast 18 mg monotherapy is estimated to extend median survival from 3.7 years without treatment to 9.1 years, more than doubling it. For patients receiving standard background therapy (nintedanib), adding nerandomilast 18 mg is predicted to extend median survival from 4.6 years to 6 years.[1]
In PPF patients, nerandomilast 18 mg monotherapy is predicted to extend median survival from 3.9 years without treatment to 7.2 years. When combined with background therapy (nintedanib), median survival is estimated to increase from 3.4 years to 4.4 years.[2]
“IPF and PPF are devastating, life-threatening diseases that relentlessly take time away from patients. In the past, unbearable side effects forced many patients to discontinue treatment, limiting the potential for sustained therapeutic effects,” said Lykke Hinsch Gylvin, M.D., Chief Medical Officer and Head of Global Medical Affairs at Boehringer Ingelheim. “Nerandomilast represents a meaningful step forward in antifibrotic therapy, offering an effective and well-tolerated treatment that patients can truly adhere to, enabling sustained long-term use. If patients can stay on treatment longer, nerandomilast has the potential to translate its predicted survival benefit into the most valuable clinical benefit: more precious time with family and loved ones.”
In the FIBRONEER™-IPF and FIBRONEER™-ILD clinical trials, nerandomilast met the primary endpoint. Both studies, targeting patients with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) respectively, evaluated the absolute change in forced vital capacity (FVC) from baseline to Week 52, demonstrating that nerandomilast slows lung function decline compared to placebo. Although neither FIBRONEER™ trial met the key secondary endpoint*, in a pooled analysis of the FIBRONEER™ trials, patients receiving nerandomilast 18 mg monotherapy showed a nominally significant 59% reduction in the risk of death compared to placebo.[3]
*The key secondary endpoint was a composite of the first occurrence of acute IPF/ILD exacerbation, first respiratory-related hospitalization, or death during the trial period.
About the Survival Model Analysis
The study used statistical models to estimate survival benefits based on data from the FIBRONEER™-IPF and FIBRONEER™-ILD clinical trials. Researchers used standard methods (Weibull distribution model) to estimate long-term survival outcomes over a 30-year period, assuming that treatment effects and discontinuation rates were consistent with those observed during the respective trial periods. [1],[2]
It should be noted that these values are model-predicted estimates, not actual patient outcomes observed in the clinical trials. Data from the FIBRONEER™-ON open-label extension study of the FIBRONEER™ trials, as well as real-world evidence, will provide further evidence on the long-term efficacy of nerandomilast.
About Nerandomilast
Boehringer Ingelheim’s nerandomilast (brand name: BOVY®) is an oral, highly selective PDE4B inhibitor with antifibrotic, immunomodulatory, epithelial-protective, and vascular-protective effects. It has been approved in the United States, China, the United Arab Emirates, and Japan for the treatment of idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) in adults.
Regulatory applications for nerandomilast in IPF and PPF are also under review in the European Union (having received a positive CHMP opinion in May 2026), the United Kingdom, and other countries, with additional approvals expected in 2026.
Boehringer Ingelheim is also exploring the therapeutic potential of nerandomilast in two rheumatic diseases: systemic sclerosis (SSc) and myositis (IIM).
About IPF and PPF
Idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) are both characterized by the accumulation of irreversible scar tissue in the lungs, affecting the lungs’ ability to take in oxygen and deliver it to the bloodstream.[4],[5],[6] Signs and symptoms of IPF and PPF include a persistent dry cough and shortness of breath during exertion.[6],[7]
In IPF, the underlying cause of pulmonary fibrosis is unknown.[4] The disease primarily affects people over the age of 50, with a higher prevalence in men than women.[8]
In PPF, lung scarring may be associated with an existing condition (such as rheumatoid arthritis or systemic sclerosis) that leads to repeated inflammation of lung tissue and eventually fibrosis. PPF can also be caused by exposure to inhaled substances (such as asbestos or mold), or be of unknown cause (idiopathic), and it progresses despite treatment of the underlying disease.[5]
IPF and PPF may affect up to 9.2 million people worldwide.[9],[10] Approximately half of patients with IPF or PPF die within 5 years of diagnosis[11],[12],[13]—a mortality rate higher than many cancers.[14],[15]
Boehringer Ingelheim
Boehringer Ingelheim is a leading global biopharmaceutical company, operating in two business areas: Human Pharma and Animal Health. The company is among the top investors in research and development in the industry, dedicated to researching breakthrough therapies to address significant unmet medical needs, thereby helping to improve or extend lives. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective, embedding sustainability throughout the entire value chain. With nearly 54,300 employees worldwide, serving more than 130 markets, the company is committed to creating a healthier, more sustainable future. For more information, please visit: www.boehringer-ingelheim.com.
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References |
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[1] Pimple et al. Predicting long-term survival benefit of nerandomilast in patients with idiopathic pulmonary fibrosis (IPF). (Poster presented at ATS 2026) |
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[2] Maher et al. Predicting long-term survival benefit of nerandomilast in patients with progressive pulmonary fibrosis (PPF). (Poster presented at EULAR 2026) |
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[5] Kondoh Y, Inoue Y. Adv Ther. 2025;42(7):2988–3001. |
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[6] van Cleemput, J, et al. Adv Ther. 2019;36, 298–317. |
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[14] Siegel RL, et al. CA Cancer J Clin. 2024;74(1):12–49. |
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[15] Vancheri C, et al. Eur Respir J. 2010;35(3):496–504. |