BioXcel's SERENITY At-Home Phase 3 Study Of BXCL501 Meets Primary Goal

(RTTNews) - 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.