BioXcel Therapeutics has received a positive recommendation from its independent Data Safety Monitoring Board (DSMB) to proceed with the SERENITY At-Home pivotal Phase 3 safety trial, which is focused on the acute treatment of agitation associated with bipolar disorders or schizophrenia. The DSMB’s endorsement allows the trial to continue as planned, following a review of safety data from the first 115 patients as of May 2, 2025.
The SERENITY At-Home trial, which is fully enrolled with over 205 patients, aims to assess the safety of BXCL501, a proprietary sublingual film formulation of dexmedetomidine, in managing agitation at home. Patients are self-administering either the active drug or a placebo when agitation episodes occur over a 12-week period. The trial is double-blind and placebo-controlled, and topline data is expected to be released in Q3 2025.
Vimal Mehta, CEO of BioXcel, expressed enthusiasm about the DSMB’s decision and the upcoming data readout, which could support a supplemental New Drug Application (sNDA) for IGALMI® in the at-home treatment setting. This represents a significant opportunity to address the unmet medical need for FDA-approved therapies for agitation linked to bipolar disorders and schizophrenia.
BXCL501 is currently under investigation not only for disturbances in these disorders but also for agitation associated with Alzheimer’s dementia, highlighting its potential versatility. The FDA has granted Breakthrough Therapy designation for BXCL501 in dementia-related agitation and Fast Track designation for its other investigational uses, emphasizing the urgency surrounding its development.
The positive developments from the SERENITY trial could offer hope for patients and caregivers dealing with the challenges of behavioral agitation, particularly in non-hospital settings. This advancements could mark a significant step towards improving quality of life for those affected by these mental health conditions.
Overall, BioXcel’s progress reflects a promising path toward innovative treatment options in an area lacking effective solutions, potentially paving the way for significant advancements in mental health care.