New Analysis of BXCL501 At-Home Administration Shows Reduction of Agitation in Bipolar and Schizophrenia

BXCL501 (sublingual dexmedetomidine) showed a reduction in agitation associated with bipolar disorder and schizophrenia in the at-home setting, particularly in severe agitation episodes.¹ This additional analysis of BXCL501, presented at the annual meeting of the American Society for Clinical Psychopharmacology, evaluated the drug for acute treatment of agitation in bipolar disorder and schizophrenia.

“These new analyses from the SERENITY At-Home Phase 3 trial further strengthen the growing body of evidence supporting BXCL501 as a potential treatment option for acute agitation associated with bipolar disorders or schizophrenia in the at-home setting,” said Dusan Kostic, PhD, senior vice president of clinical and medical affairs at BioXcel Therapeutics.¹

In the randomized, double-blind, placebo-controlled phase 3 SERENITY trial, patients self-administered BXCL501 during agitation episodes for 12 weeks. Before dosing and 2 hours post-dosing, patients completed a modified Clinical Global Impression-Severity scale. A total of 246 patients were included in the phase 3 study, with data collected from 2628 agitation episodes (average 11.7 episodes per treated patient).² Over 80% of patients completed the full 12-week trial and no discontinuations occurred due to tolerability issues in the treatment group. Adverse events were consistent with previously reported profiles, including no drug-related serious adverse events, no new or unexpected treatment emergent adverse events, and no indication of increasingly frequent adverse events over time or with repeated doses.

Positive primary safety results were reported previously from the phase 3 SERENITY study of BXCL501, showing favorable safety and efficacy of the medication.³ The latest analysis explored efficacy in agitation associated with schizophrenia and bipolar disorder in the at-home setting. BXCL501 showed reduced agitation compared with placebo across all levels of symptom severity (mild, moderate, and severe), with the most pronounced effect in severe agitation episodes. The medication continued to be beneficial with repeated dosing, regardless of severity of baseline agitation.

BXCL501, 120mcg dexmedetomidine sublingual film, is a compound approved as Igalmi for the acute treatment of agitation in schizophrenia and bipolar 1 or 2 disorder. However, the current indication is only for administration of Igalmi in a medically supervised setting.

Based on overall positive data, BioXcel Therapeutics submitted a supplemental New Drug Application (sNDA) for label expansion of the dexmedetomidine formulation to the US Food and Drug Administration (FDA). The sNDA was accepted in April 2026, with a Prescription Drug User Fee Act action date of November 14, 2026. “If approved, BXCL501 could become the first FDA-approved treatment for acute agitation in the at-home setting, significantly impacting the lives of patients,” Kostic highlighted in a press release.

References

1. BioXcel Therapeutics presents new data from SERENITY at-home phase 3 trial for agitation associated with bipolar disorders or schizophrenia at 2026 ASCP annual meeting. Press release. May 28, 2026. Accessed May 29, 2026. https://www.globenewswire.com/news-release/2026/05/28/3302675/0/en/bioxcel-therapeutics-presents-new-data-from-serenity-at-home-phase-3-trial-for-agitation-associated-with-bipolar-disorders-or-schizophrenia-at-2026-ascp-annual-meeting.html

2. BioXcel Therapeutics announces SERENITY at-home pivotal phase 3 safety trial met its primary endpoint in support of sNDA submission for label expansion of Igalmi. Press release. August 27, 2025. Accessed May 29, 2026. https://ir.bioxceltherapeutics.com/news-releases/news-release-details/bioxcel-therapeutics-announces-serenity-home-pivotal-phase-3

3. BioXcel Therapeutics reports positive topline exploratory efficacy data from SERENITY at-home pivotal phase 3 safety trial for agitation associated with bipolar disorders or schizophrenia. Press release. September 10, 2025. Accessed May 29, 2026. https://ir.bioxceltherapeutics.com/news-releases/news-release-details/bioxcel-therapeutics-reports-positive-topline-exploratory