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Bristol-Myers Squibb to Launch Phase 3 Trial for Schizophrenia Drug KarXT in Adolescents

Bristol-Myers Squibb to Launch Phase 3 Trial for Schizophrenia Drug KarXT in Adolescents

Bristol-Myers Squibb Company (BMY) announced an update on their ongoing clinical study.

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Study Overview: Bristol-Myers Squibb has commenced a Phase 3 clinical trial titled A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Schizophrenia in Adolescents (13 to 17 Years of Age). The study aims to test the effectiveness and safety of KarXT, an investigational drug, in addressing the significant unmet needs of adolescents living with schizophrenia.

Intervention/Treatment: The trial involves two groups: one receiving the experimental drug KarXT, designed to manage symptoms of schizophrenia, and another receiving a placebo for comparison. The treatment will follow a specified dosing schedule.

Study Design: The study is interventional with participants being randomized into groups. The parallel model ensures both the treatment and placebo groups are studied simultaneously. It employs a quadruple masking method, meaning the participants, care providers, investigators, and outcome assessors are all blinded to the group assignments. The trial’s primary goal is to assess treatment outcomes.

Study Timeline: The study is not recruiting yet, with a submission date of December 16, 2025. Key milestones, including the primary and estimated completion dates, have not been disclosed yet but will be critical to assess progress.

Market Implications: Following this latest update, Bristol-Myers Squibb’s advancements in adolescent schizophrenia treatment could bolster investor confidence. Positive trial outcomes could provide a competitive edge in the psychiatric drug market, particularly as other pharmaceutical companies focus primarily on adult treatments. Investors will likely monitor the study’s progression closely.

The study is currently in the planning phase, and further details can be accessed on the ClinicalTrials portal.

To learn more about BMY’s potential, visit the Bristol-Myers Squibb Company drug pipeline page.

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