BioXcel Therapeutics Announces 33% Enrollment in SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or Schizophrenia

Core Insights - BioXcel Therapeutics is progressing with its SERENITY At-Home trial, which is pivotal for evaluating the safety of BXCL501 in treating agitation associated with bipolar disorders or schizophrenia in a home setting [1][2][4] - The trial aims to enroll 200 patients and has reached 33% enrollment, with topline data expected in the second half of 2025 to support a potential supplemental new drug application (sNDA) for IGALMI® [1][3][4] Company Overview - BioXcel Therapeutics, Inc. is a biopharmaceutical company focused on developing transformative medicines in neuroscience using artificial intelligence [13] - The company’s investigational product, BXCL501, is an orally dissolving film formulation of dexmedetomidine, currently under investigation for various indications including agitation associated with Alzheimer's dementia and bipolar disorders [12][13] Trial Details - The SERENITY At-Home trial is a double-blind, placebo-controlled study assessing the safety of a 120 mcg dose of BXCL501 for acute treatment of agitation [4] - The trial is designed for patients with a history of agitation episodes, allowing them to self-administer the treatment during episodes over a 12-week period [4] Market Context - There are an estimated 23 million annual episodes of agitation associated with bipolar disorders or schizophrenia occurring in the home setting in the U.S., with no FDA-approved therapies currently available for acute treatment in this context [3][4] - The SERENITY At-Home trial represents a significant opportunity for BioXcel to address an unmet medical need in the treatment of agitation [3]