Boehringer Ingelheim advances potential first-in-class IL-11 inhibitor to Phase II Clinical Research in Idiopathic Pulmonary Fibrosis

Not intended for US and UK audiences

• BI 765423 has been developed to target IL-11, a key driver of fibrosis
  
  
• New study will investigate potential of BI 765423 to improve lung function for patients with idiopathic pulmonary fibrosis (IPF)

Ingelheim, Germany, 13 January 2026 – Boehringer Ingelheim today announced the start of a Phase IIa clinical trial evaluating BI 765423, a novel monoclonal antibody targeting interleukin-11 (IL-11), in patients with idiopathic pulmonary fibrosis (IPF). This study marks a significant milestone in the company’s commitment to advancing care for people living with progressive fibrotic lung diseases.

IPF is a progressive, life-shortening lung disease that affects over three million people worldwide and most patients experience worsening breathlessness and declining lung function. 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. Current medicines can slow disease progression but cannot fully halt lung function decline or reverse lung scarring. There remains a high unmet need for stopping disease progression or reversing the effects of IPF.

“With BI 765423, we aim to go beyond slowing disease and to pursue next generation therapies that could restore lung functionality for people living with IPF,” said Vittoria Zinzalla, Global Head of Experimental Medicine at Boehringer Ingelheim. “Our aim is to transform the lives of patients and their families by demonstrating the potential of this first-in-class IL-11 inhibitor to deliver clear benefits for patients, backed by compelling evidence and delivered at speed. “

IL-11 plays a key role in fibrosis across multiple organs, and pre-clinical studies have shown that anti-IL-11 treatment can halt fibrosis and restore barrier function, resulting in improved lung function and tissue integrity. BI 765423 is designed to bind directly to IL-11, blocking its interaction with its receptor and thereby interrupting the signaling pathways that cause fibrosis. By targeting this mechanism, BI 765423 aims not only to slow lung damage but also to help restore lung functionality.

In Phase I studies, BI 765423 showed a favorable safety and tolerability profile in healthy volunteers across a wide dose range. The Phase IIa study will be the first to evaluate its efficacy in patients with IPF. It is an acquired asset from Enleofen with in-licensed IP from Singapore Health Services and the National University of Singapore.

Boehringer Ingelheim has a long-standing commitment to advancing care in pulmonary fibrosis and was just granted FDA approval for JASCAYD®, the first new treatment option in IPF in a decade.

Boehringer Ingelheim
Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,500 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at www.boehringer-ingelheim.com.

Intended Audiences Notice
This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.