BioXcel Therapeutics Planning to Submit sNDA This Month Seeking FDA Approval for At-Home Use of IGALMI®

Core Viewpoint - BioXcel Therapeutics plans to submit a supplemental New Drug Application (sNDA) for IGALMI® to the FDA for at-home use in treating agitation associated with bipolar disorders or schizophrenia, with potential approval as early as 2026 [1][2]. Company Overview - BioXcel Therapeutics, Inc. is a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience [10]. - The company’s approach involves leveraging existing approved drugs and big data to identify new therapeutic indications [10]. Product Information - IGALMI® (dexmedetomidine) is a sublingual film used for the acute treatment of agitation associated with schizophrenia and bipolar disorder I or II in adults, administered under healthcare supervision [4]. - BXCL501, the investigational formulation of dexmedetomidine, is being studied for treating agitation in Alzheimer's dementia and bipolar disorders in the at-home setting [3]. Regulatory Status - IGALMI has received Breakthrough Therapy designation for agitation associated with dementia and Fast Track designation for agitation related to schizophrenia and bipolar disorders [3]. - The safety and efficacy of IGALMI have not been established beyond 24 hours from the first dose, and its use in children is not known [4]. Market Potential - The company is focused on launch planning for IGALMI, aiming to provide a treatment option in the at-home setting where no FDA-approved alternatives currently exist [2].