BioXcel Therapeutics announced positive safety results from the first 115 patients in its SERENITY At-Home Phase 3 trial of BXCL501 for acute treatment of agitation related to bipolar disorders or schizophrenia. The independent Data Safety Monitoring Board recommended the trial continue as planned, with topline data expected in Q3 2025. The trial is fully enrolled and continues to gather data over a 12-week period.
This positive safety update is a crucial step towards potentially expanding the use of BXCL501 (marketed as IGALMI for in-clinic use) to the at-home setting. Currently, no FDA-approved treatments exist for managing these agitation episodes at home, representing a significant unmet need for patients and their caregivers. Successful completion of this trial could offer a much-needed treatment option, potentially improving patient care and reducing the burden on healthcare systems by avoiding emergency room visits or hospitalizations.
The SERENITY At-Home trial is a double-blind, placebo-controlled study evaluating the safety of a 120 mcg dose of BXCL501 in 200 patients. Over 205 patients have been dosed, with more than 150 receiving multiple doses over the 12-week trial period. The primary endpoint is safety, measured by adverse events. Exploratory endpoints include patient- or caregiver-reported assessments of severity and change in agitation after dosing.
The positive DSMB recommendation significantly de-risks the development of BXCL501 for at-home use. If the final data confirms the initial safety profile, BioXcel Therapeutics can proceed with a supplemental New Drug Application (sNDA) for label expansion. This could open a substantial new market for BXCL501, offering a convenient and effective treatment option for agitation in the comfort of patients’ homes. This would not only benefit patients but also potentially create significant value for BioXcel Therapeutics.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
