Database Lock in Trial for New At-Home Treatment of Agitation in Bipolar Disorders and Schizophrenia

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BioXcel Therapeutics announced the completion of a database lock for the SERENITY At-Home pivotal phase 3 safety trial, which is evaluating BXCL501 (dexmedetomidine) for the acute treatment of agitation associated with bipolar disorders and schizophrenia.¹

The SERENITY At-Home phase 3 trial is a double blind, placebo study evaluating the efficacy of BXCL501 to treat agitation associated with bipolar I and II or schizophrenia. BXCL501 was granted Fast Track designation by the US Food and Drug Administration (FDA). If approved, it will be the first FDA approved at-home treatment for agitation in schizophrenia and bipolar disorders. More than 200 patients with a history of agitation despite stable treatment for schizophrenia or bipolar enrolled in the phase 3 trial. Ratios of participants with schizophrenia vs bipolar disorders were balanced in the total enrollment. When they experienced agitation episodes, participants self-administered the 120 mcg dose sublingual, orally dissolving film at-home. Data from over 2600 of these agitation episodes with use of BXCL501 treatment were collected. Participants (or their caregivers/an informant) also completed a modified global impression of severity and clinical global impression of change 2 hours after treatment to measure the patient experience in the at-home setting.

Earlier this week, BioXcel announced positive pre-supplemental New Drug Application (sNDA) meeting responses from the FDA to expand use of BXCL501 to treat agitation associated with bipolar disorders and schizophrenia.² The pre sNDA package was submitted in July with the intention of label expansion for outpatient use.³ BXCL501, as Igalmi, is FDA approved for treatment of these disorders in specifically an inpatient setting with clinician administration. The medication is also pending approval for acute treatment of agitation associated with Alzheimer dementia.

BXCL501 is a selective a-2 adrenergic receptor agonist administered either under the tongue or inside the lower lip with a dissolving film. Effectiveness and safety of the medication has not yet been studied beyond 24 hours after administration, and it is not known if the treatment is safe for children. The most common adverse effects in previous clinical trials of Igalmi were sleepiness or drowsiness, a prickling or tingling sensation or numbness of the mouth, dizziness, dry mouth, low blood pressure, and low blood pressure upon standing.¹

BioXcel announced further data and topline results are expected to be available in August. The sNDA submission is on track for the beginning of 2026.¹

Vincent O’Neill, MD, chief of product development and medical officer at BioXcel Therapeutics said in a press release, “We are pleased with the progress on our late-stage trials, which leverage our extensive clinical development experience.”

Chief executive officer of BioXcel, Vimal Mehta, PhD, added, "I want to extend our heartfelt gratitude to the clinical team, our patients, principal investigators and their study staff, and all our independent service providers for their dedication and collaborative efforts as we seek to make BXCL501 available to patients, as no FDA-approved therapies are available for the acute treatment of agitation in the at-home setting, which remains a significant need."

References

1. BioXcel therapeutics announces database lock in serenity at-home pivotal phase 3 safety trial for acute treatment of agitation associated with bipolar disorders or schizophrenia. BioXcel Therapeutics. Press release. August 19, 2025. Accessed August 19, 2025. https://ir.bioxceltherapeutics.com/news-releases/news-release-details/bioxcel-therapeutics-announces-database-lock-serenity-home.

2. Kuntz L. BXCL501 for agitation associated with bipolar disorders or schizophrenia: positive pre-sNDA meeting with FDA. Psychiatric Times. August 18, 2025. Accessed August 19, 2025. https://www.psychiatrictimes.com/view/bxcl501-for-agitation-associated-with-bipolar-disorders-or-schizophrenia-positive-pre-snda-meeting-with-fda

3. Kuntz L. Potential label expansion for Igalmi: pre-supplemental new drug application meeting package submitted. Psychiatric Times. July 21, 2025. Accessed August 19, 2025. https://www.psychiatrictimes.com/view/potential-label-expansion-for-igalmi-pre-supplemental-new-drug-application-meeting-package-submitted