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New data shows BXCL501 reduces agitation in bipolar and schizophrenia patients at home, FDA decision due Nov 14, 2026

Company Fundamentals
28 May 2026
GlobeNewsWire
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Bullish
pluang ai news

BioXcel Therapeutics presented new positive data from its Phase 3 SERENITY At-Home trial showing that BXCL501, a sublingual dexmedetomidine film, effectively reduces agitation in patients with bipolar disorders or schizophrenia when self-administered at home. The treatment showed benefits across all agitation severity levels, with the strongest effect in severe cases, and maintained effectiveness with repeated dosing over 12 weeks. The FDA has set a target action date of November 14, 2026, for the drug's supplemental New Drug Application for at-home use. If approved, BXCL501 could become the first FDA-approved treatment for acute agitation in the home setting, offering a new option for patients and caregivers.

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