JASCAYD® (nerandomilast) approved in Japan, advancing global access to a new IPF and PPF treatment

Boehringer Ingelheim Limited

Not intended for UK and US audiences

JASCAYD® (nerandomilast) now approved by Japan’s MHLW for the treatment of adults with idiopathic pulmonary fibrosis and adults with progressive pulmonary fibrosis

Approval enables access to the first oral PDE4B inhibitor with antifibrotic and immunomodulatory effects authorized for use in IPF and PPF, and the first new treatment in IPF for more than a decade

Japan joins the US, China and United Arab Emirates in approving nerandomilast, broadening global access to a new treatment option for these life-threatening lung conditions1,2

Boehringer Ingelheim today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved JASCAYD® (nerandomilast) for the treatment of adults with idiopathic pulmonary fibrosis (IPF) and adults with progressive pulmonary fibrosis (PPF). It is the first phosphodiesterase 4B (PDE4B) inhibitor with antifibrotic and immunomodulatory effects approved in these indications. The decision makes Japan the fourth market worldwide to approve nerandomilast and represents an important new treatment option for people with these progressive and life‑limiting fibrosing lung conditions.

“Idiopathic pulmonary fibrosis and progressive pulmonary fibrosis are rare and intractable diseases, which have limited treatment options. Specifically in IPF, we have seen little clinical trial success over the past decade,” said Professor Arata Azuma, MD, PhD, Head of the Department of Respiratory Medicine, Tokorozawa Mihara General Hospital/Emeritus Professor, Nippon Medical School. “The approval of JASCAYD® is a major achievement that has the potential to transform the treatment paradigm for these conditions. With a novel mechanism of action that exerts both antifibrotic and anti-inflammatory effects in the lungs, JASCAYD® demonstrated a reduction in lung function decline in both FIBRONEER™-IPF and FIBRONEER™-ILD. Furthermore, a pooled analysis of these trials demonstrated a nominally significant reduction in risk of death. The introduction of JASCAYD® as a new treatment option offers great hope to people living with IPF and PPF.”

The approval of JASCAYD® is supported by results from the Phase III FIBRONEER™‑IPF and FIBRONEER™‑ILD trials, the largest Phase III program conducted across IPF and PPF to date.3,4 In FIBRONEER™-IPF, 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 52.3 Similarly, in FIBRONEER™-ILD, nerandomilast met its primary endpoint, demonstrating a statistically significant difference in FVC absolute change versus placebo at week 52.4 While the key secondary endpoint was not met in either trial*, in a pooled analysis of both trials, a 59% reduction in the risk of death was observed in the nerandomilast 18 mg group without existing treatment compared with placebo, with a nominally significant difference.5

“Today’s approval of JASCAYD® in Japan marks a pivotal moment for people living with IPF and PPF and, in IPF, the first new treatment option in more than a decade,” said Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim. “With JASCAYD®, physicians in Japan now have a new oral treatment option that combines clinically meaningful efficacy with a well-tolerated profile that can support sustained treatment, helping more patients stay on therapy and face the future with greater confidence.”

In Japan, it is estimated that between 10,000 and 30,000 people are living with IPF,6 there are currently no national estimates for PPF. Although antifibrotic treatments are available, approximately one‑third of patients do not receive medication due to concerns about gastrointestinal and liver side effects, particularly among older adults.7,8 Of those who do begin treatment, many stop taking it early, leaving them vulnerable to disease progression.9

About FIBRONEER™

In both FIBRONEER™ trials, FIBRONEER™-IPF and FIBRONEER™-ILD, nerandomilast met its primary endpoint of absolute change in Forced Vital Capacity (FVC) from baseline to week 52 compared to placebo.3,4 FVC is a measure of lung function, measured in mL. In FIBRONEER™-IPF, the difference between placebo group in absolute change in FVC from baseline to week 52 was 44.9 mL and 68.8 mL in nerandomilast 9 mg group and 18 mg group, respectively, which demonstrated the superiority of nerandomilast over placebo, with a statistically significant difference in both groups.3 In FIBRONEER™-ILD, the difference between placebo group in absolute change in FVC from baseline to week 52 was 81.1 mL and 67.2 mL in nerandomilast 9 mg group and 18 mg group, respectively, which demonstrated the superiority of nerandomilast over placebo, with a statistically significant difference in both groups.4

*Nerandomilast did not meet its key secondary endpoint in either trial, which was time to first occurrence of any of the components of the composite endpoint: acute IPF/ILD exacerbation, first hospitalization for respiratory cause, or death – whichever occurred first.3,4

In the FIBRONEER™ trials, the most commonly observed adverse event was diarrhea, and was typically mild or moderate in intensity. 3,4 Specifically, in FIBRONEER™-IPF, diarrhea was reported in 16.0% of the placebo group, 31.1% of the nerandomilast 9 mg group, and 41.3% of the nerandomilast 18 mg group.3 In FIBRONEER™-ILD, it was reported in 24.7% of the placebo group, 29.5% of the nerandomilast 9 mg group and 36.6% of the nerandomilast 18 mg group.4 In FIBRONEER™-IPF, discontinuation due to adverse reactions occurred in patients treated with nerandomilast 18 mg (14.0%) and 9 mg (11.7%), with or without background antifibrotic treatment, compared to placebo (10.7%).3 In FIBRONEER™-ILD, adverse events led to permanent discontinuation of the trial regimen in 10.0% of the nerandomilast 18 mg group, 8.1% in the nerandomilast 9 mg group, and 10.2% in the placebo group.4

About nerandomilast

JASCAYD® (nerandomilast) is an oral PDE4B inhibitor with antifibrotic and immunomodulatory 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, 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.10,11,12 Signs and symptoms of IPF and PPF include a persistent dry cough and shortness of breath on exertion.13,14

In IPF, the root cause of pulmonary fibrosis is not known.6 The disease primarily affects people over the age of 50 and affects more men than women.15

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.10

Together, IPF and PPF may affect up to 9.2 million people worldwide.16,17 Approximately half of people with IPF or PPF die within 5 years of diagnosis18,19,20 – a higher mortality rate than many cancers.20,21,22

About 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.

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