The European Commission has approved JASCAYD (nerandomilast), the first oral PDE4B inhibitor, for adults with IPF and PPF based on Phase III FIBRONEER trials.
Written By: Kalyani Boharapi,
M. Pharm (Reg. Affairs)
Reviewed By: Pharmacally Editorial Team
Boehringer Ingelheim has announced that the European Commission has granted marketing authorization for JASCAYD® (nerandomilast) for the treatment of adults with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). The approval marks the first new treatment authorized for IPF in the European Union in more than a decade and the first new therapy for PPF in over five years.
JASCAYD is the first oral, preferential phosphodiesterase 4B (PDE4B) inhibitor approved in the EU, offering a novel mechanism of action with both antifibrotic and immunomodulatory effects. The approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in May 2026 and addresses an important unmet need in progressive fibrosing lung diseases, where treatment discontinuation due to adverse events remains a significant clinical challenge.
FIBRONEER™ Phase III Program Supported Approval
The EC decision is based on results from the Phase III FIBRONEER™ clinical program, the largest clinical trial program conducted in IPF and PPF to date. Both the FIBRONEER-IPF (NCT05321069) and FIBRONEER-ILD (NCT05321082) studies met their primary endpoint, demonstrating that nerandomilast slowed lung function decline, measured by the absolute change in forced vital capacity (FVC) from baseline to Week 52, compared with placebo.
Although the key secondary endpoint, time to first acute IPF/ILD exacerbation, respiratory-related hospitalization, or death, was not met in either study, a numerical reduction in mortality was observed across both trials, reaching nominal statistical significance in the FIBRONEER™-ILD study.
Favorable Safety and Tolerability Profile
Nerandomilast demonstrated a favorable safety and tolerability profile throughout the clinical development program. Treatment did not require routine liver monitoring, and patients receiving nerandomilast as monotherapy experienced discontinuation rates comparable to placebo. These findings may support long-term treatment adherence, an important consideration for patients living with chronic progressive fibrosing lung diseases.
Commenting on the approval, Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim, said the authorization provides physicians across Europe with a long-awaited treatment option that combines efficacy with a well-characterized safety profile while supporting long-term adherence. He also emphasized the importance of earlier recognition and diagnosis of pulmonary fibrosis, noting that timely intervention is critical for patients with progressive disease.
Professor Marlies Wijsenbeek of Erasmus MC University Medical Centre highlighted that treatment discontinuation due to side effects remains a major challenge in managing IPF and PPF. She noted that the FIBRONEER™ trials demonstrated that nerandomilast preserves lung function while offering a tolerability profile that enables patients to remain on therapy. She also emphasized the benefit of eliminating the need for ongoing liver monitoring.
Addressing the Burden of Progressive Pulmonary Fibrosis
IPF and PPF affect more than 500,000 people across Europe and are characterized by irreversible scarring of lung tissue that progressively impairs respiratory function. Once lung function is lost, it cannot be restored. Common symptoms include persistent dry cough, shortness of breath, fatigue, and clubbing of the fingers or toes.
Globally, IPF and PPF are estimated to affect up to 9.2 million people. Despite available treatments, the prognosis remains poor, with approximately half of patients dying within five years of diagnosis, a mortality rate higher than that associated with many cancers. Adverse events such as nausea, photosensitivity, and diarrhea frequently lead patients to interrupt or discontinue existing therapies, and in IPF, approximately half of those who discontinue treatment do so within six months.
Sue Farrington, President of the Federation of European Scleroderma Associations (FESCA), described the approval as a long-awaited breakthrough for the IPF and PPF community. She noted that having a treatment patients can reliably remain on offers renewed stability and hope for individuals living with progressive fibrotic lung diseases and their families.
About JASCAYD® (Nerandomilast)
JASCAYD is a twice-daily oral, preferential PDE4B inhibitor with antifibrotic and immunomodulatory properties. In addition to the European Union, the therapy has been approved for adults with IPF and PPF in the United States, China, Japan, Thailand, the United Kingdom, Brazil, and the United Arab Emirates. Regulatory submissions remain under review in additional countries, with further approvals anticipated during 2026.
Beyond pulmonary fibrosis, Boehringer Ingelheim is also investigating nerandomilast for the treatment of rheumatic diseases, including systemic sclerosis (SSc) and idiopathic inflammatory myopathies (IIM).
Reference
About the Writer
Kalyani Boharapi (LinkedIn) is a pharmacy professional and healthcare writer currently pursuing an M.Pharm in Regulatory Affairs at Dr. D. Y. Patil College of Pharmacy, with interests in pharmaceutical regulations, drug development, and healthcare innovation. She has academic exposure to dossier preparation, scientific writing, and regulatory documentation. Kalyani has also completed certification courses in Generative AI, AI in Pharma, and Bioinformatics, and actively participates in pharmaceutical conferences to stay updated with emerging trends and advancements in the healthcare and pharmaceutical industry.