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Bioxcel Therapeutics Announced Topline Exploratory Efficacy Data From SERENITY At-home Pivotal Phase 3 Safety Trial, Which Demonstrated Bxcl501 Had Continued Effects And Consistent Benefit With Repeat Dosing For Agitation Associated With Bipolar Disorders Or Schizophrenia

Author: Benzinga Newsdesk | September 10, 2025 06:31am

BXCL501 demonstrated a significant mean reduction in mCGI-S score from baseline compared to placebo at 2 hours across 2,433 treated episodes (p<.05)
Complete resolution of agitation was significantly higher with BXCL501 compared to placebo across agitation episode severity (p<.0001)
BXCL501 showed a similar reduction in agitation symptoms over both the duration of the trial and number of treated episodes, demonstrating continued effects and consistent benefit with repeat dosing of BXCL501
Based on the large body of evidence and positive FDA feedback, Company plans to submit a sNDA in Q1 2026 for expanded usage of IGALMI in the outpatient setting

Posted In: BTAI