BioXcel Therapeutics announces 33% enrollment in SERENTIY at-home Phase 3 trial

BioXcel Therapeutics (BTAI) announced it has reached 33% enrollment in its 200-patient SERENITY At-Home trial. The Phase 3 trial is designed to evaluate the safety of BXCL501 in the at-home setting for the acute treatment of agitation associated with bipolar disorders or schizophrenia. Topline data results, which are expected in the second half of 2025, are intended to support a potential supplemental new drug application submission to expand the label of the FDA-approved IGALMI sublingual film. “We are pleased with the timely progress of our SERENITY At-Home trial,” said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. “It marks the first at-home trial of BXCL501, evaluating the lowest approved dose of IGALMI – 120mcg – with safety as the primary objective. Nearly all trial sites have opened and are actively enrolling patients. We are leveraging our extensive trial experience with BXCL501 and are working closely with our clinical research organization and principal investigators to optimize patient enrollment and data collection.”