INGELHEIM, Germany, July 17, 2026
Boehringer Ingelheim has announced that the European Commission (EC) has granted marketing authorization for JASCAYD® (nerandomilast), the first oral preferential phosphodiesterase 4B (PDE4B) inhibitor approved in the European Union for the treatment of adults with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). The landmark approval introduces the first new therapy for IPF in more than a decade and the first new treatment for PPF in over five years, providing patients with an innovative oral treatment designed to slow lung function decline while maintaining a favorable safety and tolerability profile. The approval was supported by the global Phase III FIBRONEER™ clinical trial program, the largest clinical development program conducted in pulmonary fibrosis to date, highlighting Boehringer Ingelheim’s continued leadership in respiratory medicine and commitment to addressing diseases with significant unmet medical need.
FIBRONEER Phase III Trials Demonstrate Strong Clinical Benefits
The European Commission’s decision is based on positive findings from the FIBRONEER™-IPF and FIBRONEER™-ILD Phase III studies, which successfully met their primary endpoint by demonstrating that nerandomilast significantly slowed the decline in lung function, measured through forced vital capacity (FVC), compared with placebo over 52 weeks. Although the predefined key secondary endpoint was not achieved, investigators observed a numerical reduction in mortality across both studies, with nominal statistical significance reported in the FIBRONEER™-ILD trial. Importantly, JASCAYD® demonstrated a well-characterized safety profile, with monotherapy discontinuation rates similar to placebo and no requirement for routine liver monitoring, addressing a major limitation associated with currently available antifibrotic therapies. These findings position nerandomilast as a significant advancement in the treatment of progressive fibrotic lung diseases by combining efficacy with improved long-term treatment tolerability.
First-in-Class Oral Therapy Addresses Major Unmet Need
Idiopathic pulmonary fibrosis and progressive pulmonary fibrosis are chronic, irreversible lung diseases characterized by progressive scarring that permanently damages lung tissue and reduces the body’s ability to absorb oxygen. Across Europe, these conditions affect more than 500,000 people, while globally an estimated 9.2 million individuals may be living with fibrotic lung diseases. Approximately half of patients die within five years of diagnosis, making pulmonary fibrosis more lethal than many forms of cancer. Existing treatment options often lead to discontinuation because of adverse effects such as gastrointestinal complications and photosensitivity. As a first-in-class oral PDE4B inhibitor, JASCAYD® offers a novel antifibrotic and immunomodulatory mechanism of action, providing physicians with an important new therapeutic option that may improve treatment adherence while slowing disease progression. The convenience of oral administration combined with a favorable tolerability profile is expected to support long-term disease management for patients living with these life-threatening respiratory conditions.
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Boehringer Ingelheim Advances Global Respiratory Innovation
The approval of JASCAYD® further strengthens Boehringer Ingelheim’s leadership in respiratory and pulmonary fibrosis research. Beyond its approvals in the European Union, the therapy has already received regulatory authorization in the United States, United Kingdom, China, Japan, Brazil, Thailand, and the United Arab Emirates, with additional regulatory reviews underway worldwide. The company is also investigating nerandomilast in systemic sclerosis and idiopathic inflammatory myopathies, expanding its potential role across multiple fibrotic and immune-mediated diseases. This latest European approval reflects continued investment in innovative therapies that target underlying disease biology rather than symptoms alone. With the introduction of the first oral PDE4B inhibitor for IPF and PPF, Boehringer Ingelheim delivers a significant advancement for respiratory medicine while offering renewed hope to patients, caregivers, and healthcare professionals seeking more effective long-term treatment options for progressive pulmonary fibrosis.
Source: Boehringer Ingelheim press release
