New analyses from FIBRONEER™ trials suggest survival benefit with nerandomilast in IPF and PPF

June 18, 2026 04:05 ET  | Source: Boehringer Ingelheim Limited

Not intended for UK and US audiences 

  • Nerandomilast long-term survival modeling presented at American Thoracic Society (ATS) 2026 and European Alliance of Associations for Rheumatology (EULAR) 2026 international congresses.
  • Based on the modeling, nerandomilast consistently increased median survival in both idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF).1,2
  • Modeling predicts meaningful extensions in survival with nerandomilast, including a multi-year increase in median survival when used as monotherapy, and additional gains when added to standard treatment.1,2

Ingelheim, Germany – 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.1,2 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.1  

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.2 

“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.3

*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.1,2

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.              

About nerandomilast

JASCAYD® (nerandomilast) is an oral preferential PDE4B inhibitor with antifibrotic, immunomodulatory and vascular effects approved in the US, China, the UAE, and Japan for the treatment of adults with IPF and adults with PPF.

Regulatory submissions for nerandomilast in IPF and PPF are also under review in the European Union – having received a positive CHMP opinion in May 2026 – the UK, and other countries, with additional approvals anticipated in 2026. 

Boehringer Ingelheim is also exploring the 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 conditions with irreversible build-up of scar tissue in the lungs, affecting the lungs’ ability to take in and transfer oxygen into the bloodstream.4,5,6 Signs and symptoms of IPF and PPF include a persistent dry cough and shortness of breath on exertion.6,7

In IPF, the root cause of pulmonary fibrosis is not known.4 The disease primarily affects people over the age of 50 and affects more men than women.8

In PPF, the scarring of the lungs may be linked to an existing condition (e.g. rheumatoid arthritis or systemic sclerosis), which causes inflammation of the lung tissue repeatedly and leads to fibrosis. PPF can also result from exposure to inhaled substances (e.g. asbestos or mold) or be due to an unknown cause (idiopathic) and worsens despite treatment of the condition.5 

Together, IPF and PPF may affect up to 9.2 million people worldwide.9,10 Approximately half of people with IPF or PPF die within 5 years of diagnosis11,12,13 – a higher mortality rate than many cancers.14,15

Boehringer Ingelheim

Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,300 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at www.boehringer-ingelheim.com.

References

  1. Pimple et al.  Predicting long-term survival benefit of nerandomilast in patients with idiopathic pulmonary fibrosis (IPF). (Poster presented at ATS 2026)
  2. Maher et al. Predicting long-term survival benefit of nerandomilast in patients with progressive pulmonary fibrosis (PPF). (Poster presented at EULAR 2026
  3. Oldham J et al. (Pooled analysis from the FIBRONEER IPF and FIBRONEER ILD trials- ERS 2025) 2025;392(22):2203-2214.
  4. Upagupta C, et al. Eur Respir Rev. 2018;27:180033.
  5. Kondoh Y, Inoue Y. Adv Ther. 2025;42(7):2988–3001.
  6. van Cleemput, J, et al. Adv Ther. 2019;36, 298–317.
  7. Kondoh Y, et al. Respir Investig. 2021;59(6):709-740.
  8. Wang J, et al. MedComm (2020). 2024;5(10):e744.
  9. Podolanczuk AJ, et al. Eur Respir J. 2023;61(4)2200957.
  10. Cottin V, et al. Front Med (Lausanne). 2022;9:799912.　
  11. Zheng Q et al. ERJ Open Res. 2022;8(1):00591-2021.
  12. Cen Z, et al. Ann Med. 2024;56(1):2406439.
  13. Nasser M, et al. Respir Res. 2021.22 :162.
  14. Siegel RL, et al. CA Cancer J Clin. 2024;74(1):12–49.
  15. Vancheri C, et al. Eur Respir J. 2010;35(3):496–504.

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