BioXcel Therapeutics, Inc.

BioXcel Therapeutics, Inc. is a clinical-stage biopharmaceutical company headquartered in New Haven, Connecticut, USA. The company's core business revolves around leveraging artificial intelligence (AI) to discover and develop transformative medicines in the fields of neuroscience and immuno-oncology. Its mission is to utilize AI-driven drug re-innovation to identify new therapeutic indications, aiming to reduce development costs and accelerate timelines for bringing new treatments to patients.

BioXcel Therapeutics' key product is IGALMI® (dexmedetomidine) sublingual film, which is FDA-approved for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. The company's pipeline includes BXCL501, an investigational formulation of dexmedetomidine being evaluated for agitation associated with dementia, opioid withdrawal, and for at-home use in agitation related to schizophrenia and bipolar disorders. Through its wholly-owned subsidiary, OnkosXcel Therapeutics, the company is also developing BXCL701, an investigational oral innate immune activator for aggressive prostate cancer and other solid and liquid tumors.

Recent notable developments include the FDA's acceptance of a supplemental New Drug Application (sNDA) for IGALMI® for at-home use, with a PDUFA target action date of November 14, 2026. The company also announced the enrollment of the first patients in a U.S. Department of War-funded study of BXCL501 for acute stress reactions and reported positive Phase 2 topline results for BXCL501 in opioid withdrawal. Dr. Vimal Mehta serves as the Co-Founder, Chief Executive Officer, and a member of the Board of Directors. BioXcel Therapeutics has undergone a strategic reprioritization to focus on high-potential agitation-market opportunities and reduce operating expenses.