Boehringer Ingelheim’s JASCAYD® (nerandomilast) Receives Approval for Progressive Pulmonary Fibrosis
Thursday, December 11, 2025
Boehringer Ingelheim has received approval from China’s National Medical Products Administration (NMPA) for JASCAYD® (nerandomilast), marking the first new treatment for adults with progressive pulmonary fibrosis (PPF) in more than five years.
PPF is a progressive and ultimately fatal condition marked by irreversible scarring of lung tissue. It can develop as a result of autoimmune diseases or exposure to inhaled irritants. Around half of those diagnosed are expected to die within five years. Diagnosis is often delayed by up to two years, and a significant proportion of patients remain untreated.
PPF affects an estimated 5.6 million people worldwide and is often linked to underlying autoimmune conditions such as rheumatoid arthritis or systemic sclerosis. It may also arise from long-term exposure to harmful substances, including asbestos and silica. As the disease advances, lung function continues to decline, everyday activities become more difficult, and the risk of death increases. Many patients experience delays in diagnosis or discontinue treatment, further affecting outcomes.
Nerandomilast is an oral preferential PDE4B inhibitor approved in China for the treatment of IPF and PPF. It has also been approved by the U.S. Food and Drug Administration for IPF and is currently under priority review for PPF. Regulatory submissions are under way in the European Union, the UK, Japan and other regions, with additional approvals expected in 2026.
Nerandomilast is the only preferential phosphodiesterase 4B (PDE4B) inhibitor authorised for this indication. It offers immunomodulatory, vascular and antifibrotic effects, addressing several key disease pathways.
The approval is based on the largest clinical trial programme conducted in PPF to date and represents a major advance for patients who have had limited therapeutic options for this life-threatening condition.
The NMPA’s approval is based on results from the Phase III FIBRONEER™-ILD trial. The study met its primary endpoint, showing that nerandomilast slowed the decline in Forced Vital Capacity (FVC) over 52 weeks compared with placebo. FVC is a key measure of lung function, and the findings indicate meaningful benefit for patients. The treatment also showed favourable safety and tolerability, with low discontinuation rates and no need for liver monitoring. The trial results also indicated an improvement in survival, with a reduced risk of death during the study period.
The approval responds to long-standing challenges faced by people with PPF, who have had limited treatment choices for many years. The availability of nerandomilast in China is regarded as an important milestone for the PPF community. The company is also working to expand access globally.
This decision follows nerandomilast’s recent approval in China for idiopathic pulmonary fibrosis (IPF).
Source: boehringer-ingelheim.com
