Not intended for UK and US audiences

• JASCAYD® (nerandomilast) is the first oral, preferential PDE4B inhibitor approved in the European Union, delivering a novel mechanism of action with antifibrotic and immunomodulatory effects
• Phase III FIBRONEER™️trials demonstrated that nerandomilast effectively slows lung function decline in adults with idiopathic pulmonary fibrosis (IPF) and adults with progressive pulmonary fibrosis (PPF), two life-threatening, progressive lung conditions^1,2,3,4
• Nerandomilast demonstrated a favorable safety and tolerability profile in clinical trials, notably, with monotherapy discontinuation rates similar to placebo

Ingelheim, Germany - Boehringer Ingelheim today announced that the European Commission (EC) has granted marketing authorization for JASCAYD® (nerandomilast) for the treatment of adults with idiopathic pulmonary fibrosis (IPF) and adults with progressive pulmonary fibrosis (PPF). This marks the first new treatment approved in IPF in the EU in over a decade and for PPF in more than five years. As a first-in-class oral preferential phosphodiesterase 4B (PDE4B) inhibitor, nerandomilast addresses a critical unmet need by successfully slowing disease progression while remaining tolerable. 

“With JASCAYD®, physicians across the EU gain a long-awaited, new treatment option for people living with IPF and PPF that is effective, has a well-characterized safety profile and may support long-term adherence,” said Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim. “This milestone is a major advancement, but it must also be a catalyst for broader recognition that lungs can’t wait. Earlier recognition and diagnosis of pulmonary fibrosis are crucial because for people living with a progressive disease, every moment matters.”

The EC approval follows the positive CHMP opinion received in May and is based on results from the FIBRONEER™ Phase III program, the largest clinical trial program conducted in IPF and PPF to date.^1,2 In both the FIBRONEER™-IPF and FIBRONEER™-ILD trials, the primary endpoint was met: nerandomilast successfully slowed lung function decline, measured by absolute change in forced vital capacity (FVC)* from baseline to week 52 compared to placebo.^1,2 While the key secondary endpoint was not met in either trial,** a numerical reduction in mortality was observed across both trials, reaching nominal significance in FIBRONEER™-ILD.^1,2 Nerandomilast demonstrated a favorable safety and tolerability profile with no requirement for liver monitoring. As monotherapy, it showed similar discontinuation rates to placebo.^1,2 

“One of the challenges of managing IPF and PPF is seeing patients needing to stop treatment early because the side effects are too much to tolerate,” said Prof Marlies Wijsenbeek, Pulmonary Physician at the Erasmus MC University Medical Centre. “The FIBRONEER™ trials showed us that nerandomilast preserves lung function with a tolerability profile that allows patients to stay on their medication, which is a major clinical advancement that patients across the EU have been waiting for. Also, removing the burden of ongoing liver monitoring is an additional improvement for patients.” 

IPF and PPF affect more than 500,000 people across Europe,⁵ causing irreversible lung scarring that severely restricts breathing. Despite the life-threatening nature of these conditions, where approximately half of those diagnosed lose their lives within five years^6,7,8 – a prognosis worse than many cancers.^7,9,10 – many people delay or stop existing therapies due to side effects such as nausea, photosensitivity, and diarrhea.^11,12,13 In IPF specifically, approximately half of those who stop therapy do so within six months.¹³

“When diagnosed with a progressive and irreversible lung condition like IPF or PPF, your greatest fear is running out of treatment options,” said Sue Farrington, President of the Federation of European Scleroderma Associations (FESCA). “Today’s authorization is a long-awaited breakthrough for the IPF and PPF community in the EU and offers renewed hope for people living with systemic sclerosis and other diseases that can lead to progressive lung fibrosis. Having a therapy that patients can reliably stay on to preserve their lung health brings real stability and hope to families.”

About IPF and PPF

Idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) are both conditions characterized by irreversible build-up of scar tissue in the lungs, affecting the lungs’ ability to take in and transfer oxygen into the bloodstream.^14,15,16 Once lung function is lost, it’s lost forever. Signs and symptoms of IPF and PPF include a persistent dry cough, shortness of breath, fatigue and finger/toe clubbing (widening and rounding of the tips of fingers/toes).^4,16

In IPF, the root cause of pulmonary fibrosis is not known.¹⁴ The disease primarily affects people over the age of 50 and affects more men than women.¹⁷

In PPF, the scarring of the lungs may be linked to an existing condition (e.g. rheumatoid arthritis or systemic sclerosis), 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.¹⁵ 

Together, IPF and PPF may affect up to 9.2 million people worldwide.^5,18 Approximately half of people with IPF or PPF die within 5 years of diagnosis^6,7,8 – a higher mortality than many cancers.^7,9,10

About nerandomilast

JASCAYD® (nerandomilast) is a twice daily oral, preferential PDE4B inhibitor with antifibrotic and immunomodulatory effects approved in the United States, China, the United Arab Emirates, Japan, Thailand, the United Kingdom, Brazil and the European Union for the treatment of adults with IPF and for the treatment of adults with PPF.

Regulatory submissions for nerandomilast in IPF and PPF are also under review in 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).

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

*FVC is a measure of lung function, measured in mL.
**The key secondary endpoint was time to first acute IPF/ILD exacerbation, first hospitalization for respiratory cause, or death over the duration of trial

Richeldi, et al. NEJM. 2025;392:2193-2202.Maher, et al. NEJM. 2025. doi:10.1056/NEJMoa2503643Hoyer N, et al. Respir Res. 2019;20(1).Grant-Orser A, et al. BMJ Open Respir Res. 2024;11:e002333.Cottin V, et al. Front Med (Lausanne). 2022;9:799912.Zheng Q et al. ERJ Open Res. 2022;8(1):00591-2021.Cen Z, et al. Ann Med. 2024;56(1):2406439.Nasser M, et al. Respir Res 2021;22:162.Siegel RL, et al. A Cancer Journal for Clinicians. 2024;74(1):12–49.Vancheri C, et al. Eur Respir J. 2010;35(3):496–504.Esbriet SmPC — Roche, 2014.Ofev SmPC — Boehringer Ingelheim, 2025 (Last updated: Oct 2025).Levra S et al. Biomedicines. 2022;10(12):3229.Upagupta C, et al. Eur Respir Rev. 2018;27:180033.Kondoh Y, Inoue Y. Adv Ther. 2025;42(7):2988–3001.van Cleemput, J, et al. Adv Ther. 2019;36, 298–317.Wang J, et al. MedComm (2020). 2024;5(10):e744.Podolanczuk A, et al. Eur Respir J. 2023;61(4).

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• Boehringer headquarters