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, having reached 33% enrollment of the targeted 200 patients, aimed at evaluating the safety of BXCL501 for treating agitation associated with bipolar disorders or schizophrenia in a home setting [1][2][3] - Topline data results are anticipated in the second half of 2025, which will support a potential supplemental new drug application (sNDA) for expanding the label of IGALMI [1][3] Company Overview - BioXcel Therapeutics, Inc. is a biopharmaceutical company focused on developing transformative medicines in neuroscience using artificial intelligence [13] - The company’s approach involves leveraging existing approved drugs and big data to identify new therapeutic indications [13] SERENITY At-Home 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 in home settings [4] - The trial will collect safety data over a 12-week period, with patients self-administering the drug during agitation episodes [4] Market Context - There are approximately 23 million annual episodes of agitation related to bipolar disorders or schizophrenia occurring in the U.S. home setting, with no FDA-approved therapies currently available for acute treatment in this context [3][4]