New Hope for Pulmonary Fibrosis: Nerandomilast Shows Promise in Clinical Trials

Recent clinical research has demonstrated significant progress in the treatment of pulmonary fibrosis, a severe lung disease typically associated with a poor prognosis of 3 to 5 years post-diagnosis. The focus is on nerandomilast, an oral drug developed by Boehringer Ingelheim, which has shown the ability to reduce disease progression by over 50% within a year of treatment across two large-phase 3 trials.

Pulmonary fibrosis, including idiopathic pulmonary fibrosis (IPF) and secondary forms associated with autoimmune diseases or drug exposure, has long lacked effective therapies. Previous attempts to develop new drugs have largely failed during clinical testing, underscoring the need for innovative options. Nerandomilast, a selective phosphodiesterase 4B inhibitor, offers a new therapeutic avenue and can be combined with existing treatments such as nintedanib or pirfenidone.

The standout results were presented at the American Thoracic Society's Annual Congress in San Francisco, highlighting the drug’s efficacy in multiple patient groups. The FIBRONEER-IPF study focused on IPF patients, while the FIBRONEER-ILD study targets secondary progressive pulmonary fibrosis. The publication in the New England Journal of Medicine confirms the reliability of these findings.

Luca Richeldi, a leading expert in respiratory diseases at the Catholic University of the Sacred Heart, served as the global principal investigator. He emphasized that nerandomilast not only slowed disease progression but also had fewer side effects like diarrhea compared to previous therapies. Crucially, it delayed the need for oxygen therapy, which is often disabling for patients, significantly improving their quality of life.

The drug demonstrated a remarkable reduction in disease advancement, with a 50% decrease in progression over a year, based on a trial including 1,177 patients. Its benefit extends beyond IPF to other non-idiopathic fibrosis forms, broadening potential treatment options for various pulmonary conditions.

Further research is planned, focusing on early disease stages. A forthcoming two-year study will investigate whether early intervention with nerandomilast in patients with interstitial lung abnormalities (ILA) can further slow or prevent progression of fibrosis.

This breakthrough represents a major step forward in pulmonary fibrosis management, opening doors to combined and early treatment strategies that may greatly enhance patient outcomes.

Source: https://medicalxpress.com/news/2025-05-pulmonary-fibrosis-nerandomilast-inhibits-phosphodiesterase.html