BioXcel Seeks FDA Label Expansion For Schizophrenia Treatment

BioXcel Seeks FDA Label Expansion For Schizophrenia Treatment

BioXcel Therapeutics Inc. (NASDAQ:BTAI) announced that its SERENITY At-Home Phase 3 trial of BXCL501—its sublingual dexmedetomidine film for acute agitation in bipolar disorder or schizophrenia—met its primary endpoint. The results show consistent symptom reduction across 2,400+ episodes. It will now support an FDA supplemental filing to expand Igalmi's label for at-home use in Q1 2026. Efficacy in institutional settings was already established …

Primary Endpoint of Phase 3 Trial Met: BXCL501 for Agitation Associated With Bipolar Disorders or Schizophrenia

BioXcel Therapeutics reveals promising phase 3 results from the SERENITY trial, paving the way for potential at-home treatment of agitation in bipolar disorder and schizophrenia.

BioXcel to seek label update for psych drug after Phase 3 success

BioXcel is taking the next step in an effort to update the label of its psychiatric drug Igalmi. A Phase 3 trial studying Igalmi enrolled schizophrenia or bipolar disorder patients who suffer episodes of agitation ...