Daiichi Sankyo Company ((DSKYF)) announced an update on their ongoing clinical study.
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Daiichi Sankyo Company is currently conducting a Phase 1 clinical study titled ‘A Phase 1, Multicenter, Open-Label, Single-Dose Study to Assess the Pharmacokinetics, Safety and Tolerability of Quizartinib in Subjects With Severe Impaired Hepatic Function.’ The study aims to evaluate the pharmacokinetics (PK), safety, and tolerability of Quizartinib in individuals with severe hepatic impairment compared to healthy controls. This research is significant as it seeks to understand how severe liver conditions affect the processing of Quizartinib, potentially guiding safer and more effective treatment protocols.
The intervention being tested is Quizartinib, a drug administered as a single oral dose of 30 mg. It is designed to assess its pharmacokinetic profile in patients with severe hepatic impairment versus those with normal liver function.
The study employs a non-randomized, parallel intervention model without masking, focusing primarily on treatment. Participants are divided into two groups: those with severe hepatic impairment and healthy controls, both receiving the same dosage of Quizartinib.
The study began on December 13, 2024, with its primary completion and estimated completion dates yet to be announced. The most recent update was submitted on October 10, 2025. These dates are crucial for tracking the progress and expected timelines for data availability.
This study update could influence Daiichi Sankyo’s stock performance by showcasing their commitment to expanding the therapeutic applications of Quizartinib. Positive outcomes might enhance investor confidence and position the company favorably against competitors in the pharmaceutical industry, particularly in the niche of treatments for hepatic impairment.
The study is ongoing, and further details are available on the ClinicalTrials portal.
