BioXcel receives positive recommendation from DSMB for SERENITY Phase 3 trial

BioXcel Therapeutics (BTAI) announced that an independent Data Safety Monitoring Board, DSMB, recommended that the SERENITY At-Home Phase 3 safety trial of BXCL501 for acute treatment of agitation associated with bipolar disorders or schizophrenia continue without modification. The DSMB recommendation followed a review of unblinded safety data from the first 115 patients dosed as of the May 2, 2025 cutoff date. The trial is fully enrolled and collection of data over the 12-week period is continuing. “We are pleased with the favorable DSMB meeting outcome and are excited about the upcoming data readout for our first at-home trial with BXCL501,” said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. “Results are intended to help support a potential sNDA submission for label expansion of IGALMI(R) in the at-home setting – a sizeable unmet medical need given there are no FDA-approved therapies for bipolar or schizophrenia-related agitation in this environment.”