Ipsen ((GB:0MH6)) announced an update on their ongoing clinical study.
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Study Overview: Ipsen is conducting a Phase IV multicentre study titled ‘Prospective Non-interventional, Phase IV Multicentre Study to Assess the Effectiveness, Safety and Tolerability of Elafibranor 80 mg/Day in Participants With Primary Biliary Cholangitis Receiving Treatment in a Real-world Setting.’ The study aims to observe the effectiveness, safety, and tolerability of elafibranor in treating Primary Biliary Cholangitis (PBC), a rare progressive liver disease, in a real-world setting.
Intervention/Treatment: The study focuses on the drug elafibranor, administered at 80 mg/day. Elafibranor is intended to manage symptoms and slow the progression of PBC, potentially reducing the need for liver transplants.
Study Design: This is an observational cohort study with a prospective time perspective. It is non-interventional, meaning participants will continue their usual treatment while data is collected to assess the drug’s real-world effectiveness and safety.
Study Timeline: The study began on June 3, 2024, with the latest update submitted on August 27, 2025. These dates are crucial as they mark the study’s progress and ongoing recruitment status, indicating active data collection and analysis.
Market Implications: This study’s update could positively influence Ipsen’s stock performance by demonstrating the drug’s effectiveness in a real-world setting, potentially increasing investor confidence. The study’s results could also impact the competitive landscape for PBC treatments, highlighting Ipsen’s commitment to addressing unmet medical needs in this area.
The study is currently ongoing, with further details available on the ClinicalTrials portal.