BioXcel Reports SERENITY Phase 3 Efficacy Data Showing BXCL501 Cuts Severe Agitation
BTAI•Phase 3 SERENITY At-Home trial analyses showed self-administered 120-mcg BXCL501 reduced agitation across mild, moderate and severe episodes over 12 weeks, with the strongest effect in severe cases. FDA set a PDUFA target action date of November 14, 2026 for the sNDA of IGALMI for at-home acute agitation.
1. New Exploratory Efficacy Results
Phase 3 SERENITY At-Home trial analyses showed self-administered 120-mcg BXCL501 reduced agitation across mild, moderate and severe episodes over 12 weeks, with the strongest effect in severe cases.
2. Trial Design and Patient Population
The randomized, double-blind, placebo-controlled study enrolled 200 patients who self-administered 120-mcg doses during agitation episodes, assessing symptom severity via mCGI-S scales before dosing and two hours post-dose over a 12-week period.
3. FDA Regulatory Timeline
FDA set a PDUFA target action date of November 14, 2026 for the sNDA of IGALMI for at-home acute agitation treatment, following acceptance of the supplemental New Drug Application earlier this year.
4. Potential First At-Home Treatment
If approved, BXCL501 could become the first FDA-approved at-home therapy for acute agitation in bipolar disorders and schizophrenia, offering a transformative outpatient option.
