Business
BioXcel Therapeutics Announces Enrollment of First Patients in U.S. Department of War-Funded Study of BXCL501 (Sublingual Dexmedetomidine) for Treatment of Acute Stress Reactions
DoW-funded Phase 2a trial led by University of North Carolina at Chapel Hill (UNC) Institute for Trauma Recovery Positive outcomes from trial can potentially
About this update from Bioxcel Therapeutics, Inc.
[{"type":"text","content":"DoW-funded Phase 2a trial led by University of North Carolina at Chapel Hill (UNC) Institute for Trauma Recovery Positive outcomes from trial can potentially impact Veteran Affairs/Department of War Clinical Practice Guidelines for management of acute stress reactions (ASR) NEW HAVEN, Conn., April 08, 2026 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company built on artificial intelligence (“AI”) to develop transformative medicines in neuroscience, today announced the enrollment of the first patients in a U.S. Department of War (DoW)-funded Phase 2a clinical trial evaluating BXCL501 (sublingual dexmedetomidine) for the treatment of acute stress reactions (ASR), also known as acute stress disorder (ASD). The trial is being led by the University of North Carolina at Chapel Hill (UNC) Institute of Trauma Recovery and marks a significant milestone in the collaboration between BioXcel Therapeutics and UNC. The double-blind, placebo-controlled trial (NCT06943404) is designed to enroll 100 patients experiencing ASRs following motor vehicle collisions and will evaluate the potential of BXCL501 to reduce ASR symptom severity, improve neurocognitive function, and prevent the progression to chronic posttraumatic neuropsychiatric symptoms. BioXcel Therapeutics is supplying BXCL501 for the trial. ASR symptoms occur in the days and weeks after trauma, and include anxiety, sleep disturbance, concentration difficulty, pain, and somatic symptoms such as dizziness and lightheadedness. Chronic adverse posttraumatic neuropsychiatric symptoms occur when acute stress reactions do not resolve, and include persistent pain, posttraumatic stress, and depressive symptoms. ASRs are common among service men and women, police and other first responders, and survivors of shootings and natural disasters. ASRs affect more than 40 million Americans who seek emergency department care annually after traumatic stress exposure (e.g., motor vehicle collision).1,2 “Supporting service men and women resilience and effectively treating ASRs is an urgent military priority,” said Samuel McLean, M.D., MPH, Professor of Psychiatry and Emergency Medicine and Director of the Institute for Trauma Recovery at the UNC School of Medicine, and Principal Investigator of the study. “We are excited to evaluate BXCL501 as a potential treatment to ...