BioXcel Therapeutics announced the completion of the database lock for its SERENITY At-Home pivotal Phase 3 safety trial. This critical milestone means that all clinical data from the trial has been finalized and secured, making it ready for analysis.
The SERENITY At-Home trial evaluated the safety of a 120 mcg dose of BXCL501 for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home setting. Data from more than 2,600 agitation episodes were collected during the study.
Topline results from the study remain on track for release in August. The database lock is a crucial step preceding the announcement of these results, which are expected to support a supplemental New Drug Application (sNDA) for label expansion of IGALMI.
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