ONO Pharmaceutical Co ((OPHLF)) announced an update on their ongoing clinical study.
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Ono Pharmaceutical Co. Ltd is conducting a Phase 1 study titled ‘A Phase 1, Open-Label, Parallel-Group Study to Investigate the Pharmacokinetics of Tirabrutinib in Participants With Mild, Moderate, and Severe Hepatic Impairment Compared to Healthy Participants.’ The study aims to explore how the drug tirabrutinib is processed in the body among individuals with varying degrees of liver impairment compared to those with normal liver function. This research is significant as it could inform dosage adjustments and safety considerations for patients with liver issues.
The intervention being tested is tirabrutinib, an oral medication administered in a single 80 mg dose. It is designed to assess its pharmacokinetics, which refers to how the drug is absorbed, distributed, metabolized, and excreted in the body.
The study follows an interventional design with a non-randomized, parallel-group model. There is no masking involved, meaning all participants and researchers know the treatment being administered. The primary purpose of the study is to gather pharmacokinetic data.
The study began on August 31, 2025, with the latest update submitted on October 16, 2025. These dates are crucial for tracking the progress and ensuring the study adheres to its timeline.
For investors, this study could impact Ono Pharmaceutical’s stock performance by potentially expanding the market for tirabrutinib if successful. It also positions the company competitively within the pharmaceutical industry, particularly in treatments for conditions like Primary Central Nervous System Lymphoma.
The study is currently recruiting, with further details available on the ClinicalTrials portal.
