JASCAYD® (nerandomilast) approved in Japan, advancing global access to a new IPF and PPF treatment
Monday, May 18, 2026
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. 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. Similarly, in FIBRONEER™-ILD, nerandomilast met its primary endpoint, demonstrating a statistically significant difference in FVC absolute change versus placebo at week 52. 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.
“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, 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. Of those who do begin treatment, many stop taking it early, leaving them vulnerable to disease progression.
