BioXcel Therapeutics announced that an independent Data Safety Monitoring Board (DSMB) recommended the continuation of the SERENITY At-Home pivotal Phase 3 safety trial without modification. This recommendation followed a review of unblinded safety data from the first 115 patients dosed as of May 2, 2025.
The SERENITY At-Home trial, which is fully enrolled, is 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 positive DSMB outcome indicates a favorable safety profile observed thus far.
Topline data from this trial is expected in the third quarter of 2025. These results are intended to support a potential supplemental new drug application (sNDA) submission for label expansion of IGALMI in the at-home setting, addressing a significant unmet medical need.
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