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# BioXcel Plans sNDA for At-Home Bipolar Drug
- URL: https://www.fdaweb.com/bioxcel-plans-snda-for-at-home-bipolar-drug/
- Published: 2025-08-27T12:00:00.000Z
- Updated: 2026-09-14T15:20:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159764

BioXcel Therapeutics says its pivotal Phase 3 SERENITY At-Home trial met its main safety endpoint, supporting a planned supplemental NDA submission to expand the label of its agitation treatment Igalmi (BXCL501) for unsupervised use in patients with bipolar disorders or schizophrenia. The 12-week, placebo-controlled study evaluated BioXcel’s sublingual film formulation of dexmedetomidine in the outpatient setting. Results showed that the 120 mcg dose was well tolerated, with no discontinuations due to tolerability and an adverse event profile consistent with previously approved use in hospitals and other supervised settings, according to the company.

BioXcel says patients successfully self-administered BXCL501 in more than 2,400 episodes of agitation during the trial. Preliminary exploratory data also suggested consistent benefits with repeat dosing, including symptom resolution across mild to severe agitation cases.

“This outcome is transformative in our journey toward outpatient use of BXCL501,” the company says in a release, adding that it sees a “significantly larger” potential market opportunity than previously estimated. BioXcel plans to file a supplemental NDA in the first quarter of 2026.

BXCL501, marketed as Igalmi, is currently FDA-approved for the acute treatment of agitation linked to Bipolar I or II disorder and schizophrenia in medically supervised settings. If approved for at-home use, it would become the first FDA-cleared therapy for unsupervised treatment of agitation episodes, the company says.