BioXcel's BXCL501 shows positive results in treating agitation episodes in bipolar and schizophrenia patients.

BioXcel Therapeutics has announced positive results from its SERENITY At-Home trial for BXCL501, a treatment for agitation episodes in patients with bipolar disorders or schizophrenia. The trial achieved its primary endpoint of tolerability and showed continued effects with repeat dosing. BioXcel plans to submit a supplemental new drug application (sNDA) to the FDA in Q1 2026 for expanded usage of BXCL501 in the outpatient setting without healthcare supervision. The trial treated over 2400 episodes of agitation, suggesting a significant market opportunity.