BioXcel initiates patient enrollment in pivotal Phase 3 SERENITY At-Home trial for BXCL501

BioXcel Therapeutics, Inc.

Phase 3 trial evaluates safety of 120 mcg BXCL501 (dexmedetomidine ODF) for acute agitation in bipolar or schizophrenia in the at-home setting.
Double-blind, placebo-controlled study will enroll ~200 patients; patients self-administer drug/placebo over 12-week period.
Primary objective is safety; exploratory endpoint modified CGI-C two hours after dosing; trial duration expected 9–12 months.
No changes to guidance or financial outlook; company previously disclosed substantial doubt about going concern.

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