BioXcel Therapeutics announced positive topline exploratory efficacy data from its SERENITY At-Home Pivotal Phase 3 safety trial. BXCL501 demonstrated a significant mean reduction in the modified Clinical Global Impression–Severity (mCGI-S) score from baseline compared to placebo at two hours across 2,433 treated episodes (p<.05).
The trial also showed that complete resolution of agitation symptoms, as measured by mCGI-S, was significantly higher with BXCL501 compared to placebo across all agitation episode severities (p<.0001). Specifically, 50% overall resolution was seen with BXCL501 versus 33% with placebo, with severe agitation resolving in 61% of BXCL501 episodes compared to 18% on placebo.
BXCL501 maintained a consistent reduction in agitation symptoms over both the duration of the trial and with repeated dosing, indicating continued benefits. These positive results, combined with previously announced safety and tolerability data, reinforce BXCL501’s potential for at-home use and will form the basis of the sNDA submission for label expansion of IGALMI in Q1 2026.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.