BioXcel Therapeutics announced the completion of the last patient last visit (LPLV) in its pivotal Phase 3 SERENITY At-Home clinical trial. This milestone signifies the conclusion of patient data collection for the study, which evaluated the safety of a 120 mcg dose of BXCL501 for acute agitation in bipolar disorders or schizophrenia in the at-home setting.
The trial enrolled over 200 patients across 22 sites nationwide, with data collected from more than 2,200 agitation episodes. The vast majority of patients dosed completed the full 12-week study, indicating good patient retention.
Topline data from the SERENITY At-Home study is anticipated to be released this month, August 2025. These results are intended to support the planned supplemental New Drug Application (sNDA) to potentially expand the label of IGALMI for use in the at-home (outpatient) setting, addressing a significant unmet medical need.
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