BioXcel Therapeutics, Inc.

BioXcel Therapeutics, Inc. is a biopharmaceutical company that uses artificial intelligence (AI) to develop medicines in neuroscience. Its wholly owned subsidiary, OnkosXcel Therapeutics, focuses on developing medicines in immuno-oncology. The company uses a proprietary AI platform that leverages existing approved drugs or clinically evaluated product candidates, big data, and machine learning algorithms to identify new therapeutic indications, aiming to reduce development costs and accelerate timelines. BioXcel Therapeutics' most advanced neuroscience candidate is BXCL501. In indications other than those approved by the U.S. Food and Drug Administration (FDA) as IGALMI®, BXCL501 is an investigational, proprietary, orally dissolving sublingual film formulation of dexmedetomidine in development for the treatment of agitation associated with psychiatric and neurological disorders. On April 6, 2022, the FDA approved IGALMI® (dexmedetomidine) sublingual film for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults, approved for self-administration under healthcare provider supervision. On July 6, 2022, IGALMI® became commercially available in doses of 120 and 180 micrograms ("mcg"). On August 27, 2025, the SERENITY At-Home Pivotal Phase 3 trial evaluating BXCL501 for acute agitation associated with bipolar disorders or schizophrenia in the at-home setting met its primary objective, forming the basis for an sNDA submission for IGALMI®'s label expansion into the at-home setting. The company's most advanced immuno-oncology asset, BXCL701, is an investigational oral innate immune activator from OnkosXcel Therapeutics, being developed as a potential therapy for aggressive forms of prostate cancer, pancreatic cancer, and other solid and liquid tumors.