BXCL501 for Agitation Associated With Bipolar Disorders or Schizophrenia: Positive Pre-sNDA Meeting With FDA

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BioXcel Therapeutics today announced that it has received positive pre supplemental New Drug Application (sNDA) meeting responses from the US Food and Drug Administration (FDA) on its candidate BXCL501 for agitation associated with bipolar disorders or schizophrenia.¹

Outside of the FDA-approved indication, dexmedetomidine (Igalmi) sublingual film, BXCL501 is an investigational proprietary, orally dissolving film formulation of dexmedetomidine, which is a selective alpha-2 adrenergic receptor agonist.

The primary purpose of the planned meeting with FDA was to gain alignment on the content and format of the planned submission for the outpatient use of BXCL501. This includes the clinical, nonclinical, and chemistry and manufacturing and controls requirements. BioXcel received written comments from the FDA on August 14, 2025, at this pre-sNDA preliminary meeting, and they will serve as the official record. Based upon these written responses, BioXcel concluded that the objectives of the pre-sNDA meeting have been accomplished and has determined that the meeting—which was originally scheduled for August 20, 2025—is no longer required. Acceptance of the sNDA will be subject to the FDA’s review of the complete filing.

“We are pleased with the pre-sNDA meeting feedback we received from the FDA, which confirmed agreement on the content and format for our planned sNDA submission, and reflects a shared commitment to addressing the urgent needs of patients living with bipolar disorder or schizophrenia,” said Vimal Mehta, PhD, the CEO of BioXcel Therapeutics. “This marks an important milestone in our mission to bring a safe and effective outpatient treatment to patients suffering from agitation, potentially transforming the treatment paradigm.”

Igalmi is currently FDA-approved for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in medically supervised settings.² Igalmi is available in 2 dose strengths, 120 mcg and 180 mcg. Igalmi is administered under the supervision of a health care provider, placed under the tongue or behind the lower lip. Igalmi’s safety and effectiveness has not been studied beyond 24 hours from the first dose.

The regulatory package will include data from the pivotal phase 3 SERENITY At-Home trial, which support the potential label expansion for at-home use. The trial was a double-blind, placebo-controlled 12-week study designed to evaluate the safety of a 120 mcg dose of BXCL501 for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home setting.³ The trial design and protocol were agreed with FDA at a Type C Meeting held in March 2024. BioXcel anticipates sharing topline data later this month.

BXCL501 has also been granted Breakthrough Therapy designation by the FDA for the acute treatment of agitation associated with dementia and Fast Track designation for the acute treatment of agitation associated with schizophrenia, bipolar disorders, and dementia. There are no FDA-approved therapies for the acute treatment of agitation in the at-home setting.

Based on the FDA’s feedback, BioXcel believes that the planned sNDA regulatory package will be sufficient to support the sNDA submission, which is on track for the first quarter of 2026.

References

1. BioXcel Therapeutics announces positive FDA Pre-sNDA meeting comments for sNDA submission for BXCL501 in agitation associated with bipolar disorders or schizophrenia. News release. News release. August 18, 2025. https://www.globenewswire.com/news-release/2025/08/18/3134889/0/en/BioXcel-Therapeutics-Announces-Positive-FDA-Pre-sNDA-Meeting-Comments-for-sNDA-Submission-for-BXCL501-in-Agitation-Associated-with-Bipolar-Disorders-or-Schizophrenia.html

2. BioXcel Therapeutics announces FDA approval of IGALMI™ (dexmedetomidine) sublingual film for acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. News release. April 6, 2022. Accessed August 18, 2025. https://ir.bioxceltherapeutics.com/news-releases/news-release-details/bioxcel-therapeutics-announces-fda-approval-igalmitm

3. BioXcel Therapeutics announces last patient last visit in SERENITY At-Home pivotal phase 3 safety trial for acute treatment of agitation associated with bipolar disorders or schizophrenia. News release. August 1, 2025. Accessed August 18, 2025. https://ir.bioxceltherapeutics.com/news-releases/news-release-details/bioxcel-therapeutics-announces-last-patient-last-visit-serenity