BioXcel Therapeutics has reached 33% enrollment (67 patients) in its 200-patient Phase 3 SERENITY At-Home trial for BXCL501 (dexmedetomidine sublingual film). The trial aims to evaluate the safety of the lowest approved dose (120mcg) of BXCL501 for at-home treatment of agitation related to bipolar disorders or schizophrenia. Topline data is anticipated in the latter half of 2025 and will be used to support a potential supplemental New Drug Application (sNDA) to expand the current label of IGALMI®, the approved version of BXCL501.
This trial addresses a significant unmet need: an estimated 23 million annual episodes of agitation associated with bipolar disorders or schizophrenia occur at home in the U.S., with no FDA-approved treatments currently available for this specific setting. Demonstrating the safety and efficacy of BXCL501 for at-home use could significantly improve patient care by providing a readily accessible treatment option during these acute episodes, potentially preventing escalation and the need for emergency interventions. This could also alleviate strain on caregivers and the healthcare system.
The SERENITY At-Home trial is a double-blind, placebo-controlled study. Twenty-three clinical trial sites have been activated, and a Data Safety Monitoring Board will assess safety data collected over the 12-week trial period. Patients will self-administer the medication during agitation episodes, and exploratory endpoints include modified global impression of severity (mCGI-S) and change (mCGI-C) assessments two hours post-dose.
Positive results from the SERENITY At-Home trial would represent a substantial step forward for BioXcel Therapeutics, potentially expanding the market for IGALMI® considerably and positioning it as a first-in-class at-home treatment option for agitation. This would not only benefit patients and caregivers but also establish a new standard of care in managing acute psychiatric episodes in the home setting. The trial’s outcome may also influence the development of other at-home treatments for mental health conditions.
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.
