On Oct. 9, 2025, Boehringer Ingelheim’s JASCAYD® (nerandomilast) tablets has been approved by the U.S. Food and Drug Administration (FDA) as an oral treatment option for idiopathic pulmonary fibrosis (IPF) in adult patients. JASCAYD is the first and only preferential inhibitor of phosphodiesterase 4B (PDE4B) to be approved in this indication. This represents a novel mechanism of action that exerts both antifibrotic and immunomodulatory effects, thereby slowing the decline in lung function in IPF patients.

The FDA approval is based on data from two clinical trials: FIBRONEER™-IPF (NCT05321069) and Trial 2 (NCT04419506). The primary endpoint in FIBRONEER™-IPF was the absolute change from baseline in Forced Vital Capacity (FVC), a measure of lung function, in mL at week 52. JASCAYD demonstrated a significantly smaller FVC decline compared to placebo. Specifically, the adjusted mean decline in patients receiving 18 mg or 9 mg JASCAYD was -106 mL and -122 mL, respectively, versus -170 mL in the placebo group. Additionally, a treatment effect was shown as early as week two with JASCAYD 18 mg compared to placebo, with changes from baseline in FVC continuing to diverge over time to week 52.

IPF is one of the more common progressive fibrosing interstitial lung diseases. It is deadlier than many forms of cancer, with a lower five-year survival rate compared to prostate cancer, female breast cancer and colon cancer. IPF substantially impacts quality of life and half of patients succumb to the disease within five years of diagnosis. In IPF, the root cause of pulmonary fibrosis is not known.¹ Symptoms and signs of IPF include a dry and persistent cough, shortness of breath, fatigue and finger clubbing (widening and rounding of the topics of the fingers). IPF may affect up to 3.6 million people worldwide, and an estimated 200,000 people in the U.S. The disease primarily affects people over the age of 50 and affects more men than women.