BioXcel Therapeutics, Inc. (BTAI) Wednesday said that its SERENITY At-Home Phase 3 study evaluating BXCL501, the company's sublingual film formulation of dexmedetomidine, for the acute treatment for agitation associated with bipolar disorders or schizophrenia in the at-home setting, met its primary goal.
In the study, BXCL501 was well-tolerated in patients with episodes of agitation in the outpatient setting, and no discontinuations for tolerability were observed.
BXCL501 is already approved by the FDA under the brand name IGALMI for the same indication, under healthcare provider supervision.
Base on this data, the company plans to submit sNDA for label expansion of IGALMI in the at-home setting in the first quarter of 2026.
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May 01, 2026 15:54 ET Central banks dominated the economics news flow this week with almost all major ones announcing their latest policy decisions and many boosted expectations for a rate hike in June. In other news, several countries released the preliminary data for first quarter economic growth. In the U.S., comments by Fed Chair Jerome Powell were also in focus as his term ends this month.