BioXcel Therapeutics receives positive FDA feedback on sNDA submission.

BioXcel Therapeutics announced that it has received positive pre-sNDA meeting responses from the FDA, aligning on the content and format of its planned sNDA submission for BXCL501. The sNDA aims to expand the IGALMI label for at-home (outpatient) use, with a submission planned for Q1 2026. The FDA's feedback supports the planned regulatory package, keeping the submission on track.

BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, has received positive pre-sNDA meeting responses from the U.S. Food and Drug Administration (FDA). The meeting, originally scheduled for August 20, 2025, was held to gain alignment with the FDA regarding the content and format of the Company’s planned supplemental New Drug Application (sNDA) submission for the at-home (outpatient) use of BXCL501. The FDA's feedback supports the planned regulatory package, keeping the sNDA submission on track for the first quarter of 2026 [1].

The primary purpose of the pre-sNDA meeting was to discuss the clinical, nonclinical, and chemistry and manufacturing and controls (CMC) requirements for the planned sNDA submission. The FDA's positive feedback indicates that the Company's planned sNDA package is sufficient to support the submission. Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics, expressed satisfaction with the meeting's outcome, stating, "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" [1].

The sNDA submission aims to expand the IGALMI label for at-home use. IGALMI, currently FDA-approved for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in medically supervised settings, is available in two dose strengths, 120 mcg and 180 mcg. To support the potential label expansion, data from the pivotal Phase 3 SERENITY At-Home trial will be included in the regulatory package. The SERENITY At-Home Phase 3 trial is a double-blind, placebo-controlled 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. The trial design and protocol were agreed upon with the FDA at a Type C Meeting held in March 2024. The Company recently announced the completion of the last patient last visit (LPLV), with topline data expected this month [1].

BXCL501 is an investigational proprietary, orally dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist. It has 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. The safety and efficacy of BXCL501 for these investigational uses have not been established [1].

References:
[1] 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