Ipsen’s Phase III Study on Elafibranor: A Potential Game-Changer for Liver Disease Treatment

Ipsen ((GB:0MH6)) announced an update on their ongoing clinical study.

In a significant advancement for liver disease treatment, Ipsen is conducting a Phase III clinical study titled ‘A Phase III Randomised, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm Study to Evaluate the Efficacy and Safety of Elafibranor 80 mg on Long-Term Clinical Outcomes in Adult Participants With Primary Biliary Cholangitis (PBC).’ The study aims to assess whether elafibranor can prevent disease progression in patients with Primary Biliary Cholangitis, a condition that can lead to liver cirrhosis and potentially require a liver transplant.

The study tests the efficacy of elafibranor, an experimental drug administered as a daily 80 mg oral tablet, against a placebo. Elafibranor is intended to prevent clinical outcomes that indicate disease worsening, such as the need for a liver transplant or death, while also evaluating its long-term safety and effects on symptoms like itching and fatigue.

This interventional study is designed with a randomized, parallel-group model and employs triple masking to ensure unbiased results. The primary purpose is treatment-focused, aiming to provide a new therapeutic option for PBC patients.

The study began on August 22, 2023, and is currently recruiting participants. It is expected to reach primary completion by August 26, 2025, marking a significant milestone in its timeline. The last update was also submitted on August 26, 2025, indicating ongoing progress.

For investors, this study could influence Ipsen’s stock performance positively if elafibranor proves effective, potentially enhancing Ipsen’s competitive position in the pharmaceutical industry. The outcome of this study may also impact investor sentiment, given the high stakes involved in developing treatments for chronic liver diseases.

The study is ongoing, with further details available on the ClinicalTrials portal.