BioXcel Reaches Key Milestone in Phase 3 Trial for At-Home Agitation Treatment, Results Coming in August

Author: Benzinga Newsdesk | August 19, 2025 07:06am

BioXcel Therapeutics, Inc. (NASDAQ:BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced completion of the database lock for its SERENITY At-Home pivotal Phase 3 safety trial for acute treatment of agitation associated with bipolar disorders or schizophrenia. Topline results from the study are expected in August.

"The database lock is a significant step forward, and we are thrilled to have reached this critical milestone in an efficient manner as we look forward to reporting top-line results from the SERENITY At-Home pivotal Phase 3 safety trial soon," said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. "I want to extend our heartfelt gratitude to the clinical team, our patients, principal investigators and their study staff, and all our independent service providers for their dedication and collaborative efforts as we seek to make BXCL501 available to patients, as no FDA-approved therapies are available for the acute treatment of agitation in the at-home setting, which remains a significant need."

The SERENITY At-Home Phase 3 trial is a double-blind, placebo-controlled study designed to evaluate the safety of a 120 mcg dose of BXCL501 for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home setting:

• The trial enrolled more than 200 patients across 22 sites nationwide, with no single site enrolling more than 11% of the total patient population.
• The distribution of enrolled patients was balanced between the two patient populations, bipolar disorders and schizophrenia.
• The vast majority of patients dosed completed the full 12-week study.
• Data from more than 2,600 agitation episodes was collected.

BioXcel partnered with Worldwide Clinical Trials (WCT), a recognized Clinical Research Organization (CRO), to conduct the Serenity At-Home trial. Robust sponsor oversight controls were implemented to oversee the collaborators and patient safety, including patient eligibility reviews, two DSMB reviews during the peak recruitment period, and ensuring that no clinical site contributed an outsized percentage of the randomized patients. Independent industry experts were engaged by BioXcel for additional oversight of high enrolling sites for GCP compliance.

BXCL501 was granted Fast Track Designation for the acute treatment of agitation associated with bipolar disorders or schizophrenia. There are no FDA-approved therapies for the acute treatment of agitation in the at-home setting.

Posted In: BTAI