Ipsen ((GB:0MH6)) announced an update on their ongoing clinical study.
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Study Overview: Ipsen is conducting a Phase I clinical study titled A Phase I, Open-label, Parallel-group Study to Evaluate the Single-dose Pharmacokinetics of Palovarotene in Male and Female Participants With Moderate and Severe Hepatic Impairment and Matched Participants With Normal Hepatic Function. The study aims to understand how liver impairment affects the processing of palovarotene, a drug intended for specific medical conditions, compared to healthy individuals. This research is significant as it could inform dosage adjustments and safety measures for patients with liver issues.
Intervention/Treatment: The study tests the drug Palovarotene, administered in a single dose of up to 10 mg. The purpose is to evaluate its pharmacokinetics and safety in participants with varying degrees of liver function.
Study Design: This interventional study uses a randomized, parallel-group model without masking. Participants are divided into three groups based on liver function: healthy, moderate impairment, and severe impairment. The primary goal is to gather basic scientific data on the drug’s behavior in the body.
Study Timeline: The study began on March 24, 2025, with the last update submitted on August 28, 2025. These dates are crucial for tracking the study’s progress and ensuring timely updates on its findings.
Market Implications: This study could impact Ipsen’s stock performance by potentially expanding the use of Palovarotene to patients with liver impairments, thus broadening its market. Investors may view this as a positive development, especially if the study results in favorable safety and efficacy outcomes. Competitors in the liver treatment space may need to adjust their strategies accordingly.
The study is currently recruiting, with further details available on the ClinicalTrials portal.