BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company leveraging artificial intelligence to develop innovative neuroscience treatments, announced it plans to submit a supplemental New Drug Application (sNDA) this month to the U.S. Food and Drug Administration (FDA) for the at-home use of IGALMI® (dexmedetomidine) sublingual film. The application seeks approval for the acute treatment of agitation associated with bipolar disorders or schizophrenia in a home setting. Vimal Mehta, Ph.D., Chief Executive Officer of BioXcel Therapeutics, said the company is making strong progress toward the sNDA submission and launch planning. “Based on the accelerated timeline, we believe IGALMI could be approved for at-home use as early as 2026,” Mehta said. “We are now focused on preparing for launch and look forward to potentially offering a much-needed treatment option for patients and caregivers, where no FDA-approved solutions currently exist.” IGALMI® is already approved by the FDA for the acute treatment of agitation in adults with schizophrenia or bipolar I or II disorder, but it must be administered under the supervision of a healthcare provider. The new sNDA aims to expand its use to the at-home environment, a significant shift that could improve access and reduce the burden on clinical settings. The active ingredient in IGALMI®, dexmedetomidine, is a selective alpha-2 adrenergic receptor agonist. The investigational formulation, known as BXCL501, is an orally dissolving sublingual film being studied for acute agitation in multiple conditions, including Alzheimer’s dementia, bipolar disorders, and schizophrenia. It has received Breakthrough Therapy designation from the FDA for agitation in dementia and Fast Track designation for agitation in schizophrenia, bipolar disorders, and dementia. The company emphasized that the safety and efficacy of BXCL501 for these new uses have not yet been established. Important safety concerns include low blood pressure, dizziness, slow heart rate, and potential heart rhythm changes (QT prolongation). Patients must be monitored for these effects, and the drug should not be used in individuals with certain heart conditions or those taking medications that affect heart rhythm. Drowsiness is a common side effect, and patients should avoid driving or operating machinery for at least eight hours after use. BioXcel Therapeutics is also advancing other programs, including SERENITY and TRANQUILITY, and continues to use its AI-driven platform, EvolverAI, to repurpose existing drugs and discover new treatments. The company’s long-term goal is to transform the standard of care in neuropsychiatry by combining machine learning with human insight. The sNDA submission is part of a broader strategy to redefine how agitation is managed, particularly in real-world settings. While the company remains focused on regulatory progress, it also faces challenges, including the need for additional funding, the risk of material changes in its financial position, and the uncertainty of clinical and commercial success. Forward-looking statements in the announcement are based on current expectations and assumptions, and actual results may differ materially due to various risks, including those related to drug development, regulatory approval, market acceptance, and financial stability. The company cautions that these statements are not guarantees of future performance and disclaims any obligation to update them except as required by law.