BioXcel Therapeutics Announces Successful Phase 3 Trial Results for BXCL501 in Treating Agitation at Home for Bipolar Disorder and Schizophrenia Patients
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BioXcel Therapeutics Inc. has announced successful results from the SERENITY At-Home Pivotal Phase 3 trial for BXCL501, a sublingual film for treating agitation in bipolar disorder and schizophrenia patients at home. The trial met its primary endpoint, showing BXCL501 was well-tolerated with no serious drug-related adverse events. This data will support a supplemental New Drug Application for expanding IGALMI®'s label for at-home use, with submission expected in Q1 2026.
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