BioXcel Therapeutics announces SERENITY Phase 3 trial met primary endpoint

BioXcel Therapeutics (BTAI) announced that the SERENITY At-Home Pivotal Phase 3 trial evaluating the safety of BXCL501, the Company’s proprietary, sublingual film formulation of dexmedetomidine, as an acute treatment for agitation associated with bipolar disorders or schizophrenia in the at-home setting, met its primary endpoint. The data from this successful study will form the basis of the sNDA submission for label expansion of IGALMI in the at-home setting planned for the first quarter of 2026. SERENITY AT-Home Primary Endpoint Data: The 120 mcg dose of BXCL501 was well-tolerated in patients with episodes of agitation in the outpatient setting and met the primary objective. This tolerability outcome was observed across repeat dosing and through the duration of the trial; No discontinuations due to tolerability in the BXCL501 arm; Adverse event profile consistent with approved IGALMI label and multiple clinical trials in the institutional setting; No drug-related serious adverse events, syncopes or falls reported; No new or unexpected treatment emergent adverse events; No severe TEAEs associated with BXCL501 treatment and most TEAEs were mild; No trend of more frequent AEs over time or with repeat dosing; Tolerability remained consistent throughout the repeat dosing in the trial