- Business
- BioXcel Therapeutics, Inc. is a U.S.-based, artificial intelligence-enabled biopharmaceutical company focused on discovering, developing and commercializing medicines for neuroscience indications, with immuno-oncology activities conducted through its wholly owned subsidiary, OnkosXcel Therapeutics, LLC. The Company applies a drug re-innovation model that combines clinically validated compounds and approved drugs with proprietary data analytics and machine-learning algorithms to identify new therapeutic uses and develop differentiated formulations. Its principal commercial product is IGALMI® (dexmedetomidine) sublingual film, a prescription medicine administered under healthcare-provider supervision for the acute treatment of agitation associated with schizophrenia and bipolar I or II disorder in adults; the product is placed under the tongue or behind the lower lip. Its lead development asset, BXCL501, is a proprietary orally dissolving formulation of dexmedetomidine being developed for additional neuropsychiatric uses, including at-home treatment of acute agitation associated with schizophrenia or bipolar I or II disorder in adults, acute agitation associated with Alzheimer’s dementia, acute stress reactions and opioid withdrawal. BXCL501 has received FDA Breakthrough Therapy designation for agitation associated with Alzheimer’s dementia, while its investigational uses remain unapproved. BioXcel serves healthcare providers, hospitals, behavioral-health facilities, patients, pharmaceutical trade partners and other participants in the U.S. healthcare market. Incorporated in 2017, the Company is headquartered in New Haven, Connecticut. In 2026, BioXcel submitted and obtained FDA acceptance of a supplemental New Drug Application seeking to expand IGALMI’s use into the at-home setting, with a Prescription Drug User Fee Act target action date of November 14, 2026; it also completed an approximately $8.0 million registered direct offering and advanced clinical and commercial-preparation activities for the potential outpatient launch. In August 2026, BioXcel entered into an asset sale agreement with Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd., covering substantially all Company assets, including IGALMI and the pending BXCL501 supplemental NDA; Teva is designated as the stalking-horse bidder in a proposed court-supervised Section 363 sale process. Concurrently, BioXcel, OnkosXcel Therapeutics, LLC, and OnkosXcel Employee Holdings, LLC commenced voluntary Chapter 11 proceedings in the U.S. Bankruptcy Court for the District of Delaware, obtained a commitment for $19 million in debtor-in-possession financing from existing secured lenders and stated that IGALMI would remain commercially available while it conducts the sale process.