Boehringer Ingelheim expands global rollout of JASCAYD® following Japan approval for pulmonary fibrosis treatment

Boehringer Ingelheim expands global rollout of JASCAYD® following Japan approval for pulmonary fibrosis treatment

(IN BRIEF) Boehringer Ingelheim has received approval from Japan’s Ministry of Health, Labour and Welfare for JASCAYD® (nerandomilast) to treat adults with idiopathic pulmonary fibrosis and progressive pulmonary fibrosis. The oral PDE4B inhibitor is the first therapy of its kind approved for these conditions and the first new IPF treatment introduced in more than ten years. Approval was based on Phase III FIBRONEER™ clinical trials showing that nerandomilast slowed lung function decline compared with placebo and demonstrated a potential reduction in mortality risk. Japan becomes the fourth market to authorize the treatment as Boehringer Ingelheim continues global regulatory expansion efforts.

(PRESS RELEASE) INGELHEIM, 18-May-2026 — /EuropaWire/ — Boehringer Ingelheim has 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 progressive pulmonary fibrosis (PPF), expanding global access to the company’s newly developed lung disease therapy.

The approval makes Japan the fourth market worldwide to authorize nerandomilast following approvals in the United States, China and the United Arab Emirates. According to the company, JASCAYD® is the first phosphodiesterase 4B (PDE4B) inhibitor approved for IPF and PPF treatment, combining antifibrotic and immunomodulatory effects in a single oral therapy. The company also described it as the first new approved treatment option for IPF in more than a decade.

Professor Arata Azuma, Head of the Department of Respiratory Medicine at Tokorozawa Mihara General Hospital and Emeritus Professor at Nippon Medical School, said the approval has the potential to significantly change the treatment landscape for pulmonary fibrosis. He highlighted the therapy’s dual antifibrotic and anti-inflammatory mechanisms and pointed to clinical trial data showing reduced lung function decline in patients receiving nerandomilast.

The approval is based on data from the Phase III FIBRONEER™-IPF and FIBRONEER™-ILD clinical trials, described by the company as the largest Phase III research program conducted for IPF and PPF to date. In both trials, nerandomilast met the primary endpoint of slowing lung function decline, measured through changes in forced vital capacity (FVC) over 52 weeks compared with placebo.

In pooled analyses of the two studies, the company reported a nominally significant 59% reduction in risk of death in patients receiving the 18 mg dose of nerandomilast without existing treatment compared with placebo.

Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim, described the approval as a pivotal moment for people living with IPF and PPF, emphasizing that physicians in Japan now have access to a new oral treatment option that combines clinically meaningful efficacy with a tolerable safety profile aimed at helping patients remain on therapy longer.

According to the company, between 10,000 and 30,000 people in Japan are estimated to be living with IPF, while national estimates for PPF are currently unavailable. The company noted that existing antifibrotic therapies are not always used because of concerns regarding gastrointestinal and liver-related side effects, particularly among older adults.

The FIBRONEER™ studies also evaluated the safety profile of nerandomilast. The most commonly reported adverse event was diarrhea, which was generally mild or moderate in severity. Trial discontinuation rates due to adverse reactions remained relatively comparable to placebo groups across the studies.

Boehringer Ingelheim said regulatory reviews for nerandomilast are continuing in the European Union, the United Kingdom and additional international markets, with further approvals anticipated during 2026.

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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SOURCE: Boehringer Ingelheim