NEW HAVEN, Conn. | May 28, 2026
BioXcel Therapeutics presented new positive data from its Phase 3 SERENITY At-Home clinical trial at the 2026 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, highlighting the efficacy of BXCL501 (sublingual dexmedetomidine) for the acute treatment of agitation associated with bipolar disorders and schizophrenia in the at-home setting. The new analyses demonstrated consistent reductions in agitation severity across a broad range of patients, further supporting the potential expansion of IGALMI® into a first-in-class at-home treatment option for psychiatric agitation.
BXCL501 Demonstrates Consistent Efficacy Across Agitation Severity Levels
BioXcel Therapeutics reported that exploratory efficacy analyses from the randomized, double-blind, placebo-controlled Phase 3 study showed that BXCL501 significantly reduced agitation symptoms compared with placebo regardless of baseline symptom severity. Patients participating in the study self-administered the treatment during agitation episodes over a 12-week period and evaluated symptom changes using the modified Clinical Global Impression-Severity (mCGI-S) scale before dosing and two hours after treatment. The findings revealed meaningful improvements in patients experiencing mild, moderate, and severe agitation, with the strongest treatment effect observed among individuals with severe agitation episodes.
Durable Benefits Observed with Repeated At-Home Dosing
The new analyses also demonstrated that the clinical benefits of BXCL501 were maintained throughout repeated dosing events during the study period. Importantly, treatment effectiveness remained consistent regardless of baseline agitation severity, suggesting that the therapy may provide reliable symptom control for patients who experience recurring episodes of agitation. These findings build upon previously reported positive primary safety results from the SERENITY At-Home trial and further strengthen the clinical profile of BXCL501 as a potential treatment option for managing psychiatric agitation outside traditional healthcare settings.
Advertisement
FDA Review Underway for Potential At-Home Use Approval
BioXcel Therapeutics is currently seeking regulatory approval to expand the use of IGALMI®, which contains BXCL501, for at-home treatment of acute agitation associated with bipolar disorders or schizophrenia. The U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) and assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 14, 2026. If approved, IGALMI would become the first FDA-approved therapy specifically indicated for the at-home treatment of acute agitation in patients with bipolar disorders or schizophrenia, potentially transforming care by allowing earlier intervention and reducing the need for emergency medical services.
According to Dusan Kostic, Ph.D., Senior Vice President of Clinical and Medical Affairs at BioXcel Therapeutics, the latest findings further strengthen the growing body of evidence supporting BXCL501 as a safe and effective treatment for acute agitation in community settings. The company believes the therapy could address a significant unmet need by providing patients and caregivers with a rapid, non-invasive treatment option that can be administered at the onset of agitation symptoms.
Source: BioXcel Therapeutics press release
