Boehringer Ingelheim Gains EU Approval for New Pulmonary Fibrosis Treatment JASCAYD

Boehringer Ingelheim Gains EU Approval for New Pulmonary Fibrosis Treatment JASCAYD

(IN BRIEF) Boehringer Ingelheim has received European Commission marketing authorisation for JASCAYD® (nerandomilast) for adults with idiopathic pulmonary fibrosis and progressive pulmonary fibrosis. JASCAYD is the first oral preferential PDE4B inhibitor approved in the EU, offering a new mechanism of action with antifibrotic and immunomodulatory effects. The approval is based on the Phase III FIBRONEER™ programme, where nerandomilast slowed lung function decline in both IPF and PPF trials. The approval marks the first new EU treatment for IPF in more than a decade and for PPF in more than five years. Boehringer Ingelheim said the treatment showed a favourable safety and tolerability profile, with no requirement for liver monitoring and monotherapy discontinuation rates similar to placebo.

(PRESS RELEASE) INGELHEIM, 17-Jul-2026 — /EuropaWire/ — Boehringer Ingelheim has announced that the European Commission has granted marketing authorisation for JASCAYD®, also known as nerandomilast, for the treatment of adults with idiopathic pulmonary fibrosis and adults with progressive pulmonary fibrosis.

JASCAYD is the first oral preferential phosphodiesterase 4B inhibitor approved in the European Union. It offers a novel mechanism of action with antifibrotic and immunomodulatory effects.

The approval marks the first new treatment authorised in the EU for idiopathic pulmonary fibrosis in more than a decade and the first for progressive pulmonary fibrosis in more than five years.

Boehringer Ingelheim said the approval addresses an important unmet need by offering a treatment that slows disease progression while showing a favourable safety and tolerability profile in clinical trials.

Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim, said the approval gives physicians across the EU a long-awaited new treatment option for people living with IPF and PPF.

“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 Deshpande.

He added that the milestone should also increase awareness of the need for earlier recognition and diagnosis of pulmonary fibrosis, noting that every moment matters for people living with progressive disease.

The European Commission approval follows a positive opinion from the Committee for Medicinal Products for Human Use in May and is based on results from the FIBRONEER™ Phase III programme, described by Boehringer Ingelheim as the largest clinical trial programme conducted to date in IPF and PPF.

In both the FIBRONEER™-IPF and FIBRONEER™-ILD trials, nerandomilast met the primary endpoint by slowing lung function decline, measured by absolute change in forced vital capacity from baseline to week 52, compared with placebo.

Although the key secondary endpoint was not met in either trial, a numerical reduction in mortality was observed across both studies, reaching nominal significance in FIBRONEER™-ILD.

Nerandomilast demonstrated a favourable safety and tolerability profile, with no requirement for liver monitoring. As monotherapy, discontinuation rates were similar to placebo.

Professor Marlies Wijsenbeek, Pulmonary Physician at Erasmus MC University Medical Centre, said one of the challenges in managing IPF and PPF is that patients sometimes stop treatment early because side effects are difficult to tolerate.

“The FIBRONEER™ trials showed us that nerandomilast preserves lung function with a tolerability profile that allows patients to stay on their medication,” said Prof Wijsenbeek.

She described this as a major clinical advancement for patients across the EU and said the removal of ongoing liver monitoring is an additional improvement.

IPF and PPF affect more than 500,000 people across Europe and cause irreversible scarring of the lungs, severely restricting breathing. Approximately half of those diagnosed with these progressive lung diseases die within five years, a prognosis worse than many cancers.

Existing therapies can be difficult for some patients to continue because of side effects such as nausea, photosensitivity and diarrhoea. In IPF, around half of patients who stop therapy do so within six months.

Sue Farrington, President of the Federation of European Scleroderma Associations, said the approval is a long-awaited breakthrough for the IPF and PPF community in the EU.

“When diagnosed with a progressive and irreversible lung condition like IPF or PPF, your greatest fear is running out of treatment options,” said Farrington.

She said the authorisation offers renewed hope for people living with systemic sclerosis and other diseases that can lead to progressive lung fibrosis.

Idiopathic pulmonary fibrosis and progressive pulmonary fibrosis are both characterised by the irreversible build-up of scar tissue in the lungs, reducing the lungs’ ability to take in oxygen and transfer it into the bloodstream. Once lung function is lost, it cannot be regained.

Signs and symptoms may include persistent dry cough, shortness of breath, fatigue and clubbing of the fingers or toes.

In IPF, the cause of the fibrosis is unknown. The condition mainly affects people over the age of 50 and is more common in men than women.

In PPF, lung scarring may be linked to another condition, such as rheumatoid arthritis or systemic sclerosis, exposure to inhaled substances such as asbestos or mould, or an unknown cause. The disease worsens despite treatment of the underlying condition.

Together, IPF and PPF may affect up to 9.2 million people worldwide.

JASCAYD is a twice-daily oral preferential PDE4B inhibitor with antifibrotic and immunomodulatory effects. It has been approved in the United States, China, the United Arab Emirates, Japan, Thailand, the United Kingdom, Brazil and the European Union for adults with IPF and adults with PPF.

Regulatory submissions for nerandomilast in IPF and PPF are 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 and myositis.

Boehringer Ingelheim is a biopharmaceutical company active in human and animal health. Founded in 1885 and independently owned, the company focuses on research and development in areas of high unmet medical need and employs approximately 54,300 people across more than 130 markets.

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 diagnosis6,7,8 – 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

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15. Kondoh Y, Inoue Y. Adv Ther. 2025;42(7):2988–3001.
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17. Wang J, et al. MedComm (2020). 2024;5(10):e744.
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Tereza Urbankova
Senior Media Relations Manager
E-Mail: press@boehringer-ingelheim.com
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SSOURCE: Boehringer Ingelheim