BioXcel Therapeutics announced a second positive recommendation from an independent Data Safety Monitoring Board (DSMB) to continue the SERENITY At-Home pivotal Phase 3 safety trial without modification. This recommendation followed a review of unblinded safety data from 178 patients dosed as of May 28, 2025.
The trial, which is fully enrolled, is evaluating the safety of BXCL501 for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home setting. The repeated positive DSMB recommendations reinforce the favorable safety profile observed in the study.
Topline data from the SERENITY At-Home trial is expected in the third quarter of 2025. These results are intended to support a potential supplemental new drug application (sNDA) submission to expand the IGALMI label for at-home use, addressing a large unmet medical need.
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