BioXcel Therapeutics(US:BTAI) Globenewswire·2026-02-19 12:00Core Insights - The discussion will focus on the high unmet need and lack of FDA-approved treatment options for acute agitation episodes in Alzheimer's dementia, affecting approximately 100 million episodes annually [1][2]. Company Overview - BioXcel Therapeutics, Inc. is a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience [6]. - The company is advancing preparations for the TRANQUILITY In-Care Phase 3 trial, which is a double-blind, placebo-controlled study evaluating BXCL501 for treating acute agitation episodes in Alzheimer's dementia [4][9]. Product Information - BXCL501 is a late-stage product candidate being evaluated for acute agitation episodes in Alzheimer's dementia, with no current FDA-approved therapies for this condition [3][8]. - BXCL501 has received Breakthrough Therapy designation from the FDA for the acute treatment of agitation associated with dementia and Fast Track designation for agitation associated with schizophrenia and bipolar disorders [8]. Clinical Trial Details - The TRANQUILITY In-Care trial aims to enroll approximately 200 patients aged 55 and older with mild to severe dementia, assessing the efficacy and safety of a 60 mcg dose of BXCL501 over a 12-week period [9]. - The primary endpoint of the trial is a change from baseline in the Positive and Negative Syndrome Scale-Excitatory Component total score at two hours post-first dose [9]. Event Information - A virtual key opinion leader (KOL) roundtable will be held on February 27, 2026, to discuss acute agitation episodes in Alzheimer's dementia and the potential role of BXCL501 [1][2][4]. - The event will be moderated by Anjalee Khemlani, an award-winning healthcare journalist [4]. Expert Panel - The roundtable will feature medical professionals specializing in geriatric psychiatry and Alzheimer's care, including George T. Grossberg, MD, and Anton P. Porsteinsson, MD [7].