BioXcel Therapeutics, Inc. (BTAIQ)

BioXcel Therapeutics, Inc. is a biopharmaceutical company that uses artificial intelligence approaches to develop medicines in neuroscience and immuno-oncology. Its proprietary AI platform combines big data and machine learning algorithms with existing approved drugs and clinically evaluated product candidates to identify new therapeutic indications. The company says this approach can lower development cost and time. Tools include a knowledge graph linking neuropsychiatric symptoms, brain circuits, drug targets and existing drugs. The company's in-house capability is complemented by services and technology from BioXcel LLC, its former parent company.

The lead product is IGALMI (dexmedetomidine, or Dex) sublingual film. The FDA approved it in April 2022 for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults, and it is self-administered under the supervision of a health care provider. It became commercially available in July 2022 in 120 and 180 microgram doses. Its investigational counterpart, BXCL501, is an orally dissolving film formulation of Dex. Trials are underway for at-home use in agitation associated with bipolar disorders and schizophrenia, for acute agitation in Alzheimer's patients in residential care facilities and nursing homes, and for adjunctive treatment of Major Depressive Disorder. The immuno-oncology asset BXCL701 is an investigational oral innate immune activator being developed for aggressive prostate cancer, pancreatic cancer and other solid and liquid tumors.

IGALMI targets agitation in schizophrenia and bipolar disorder, with potential expansion into agitation in Alzheimer's disease, in the U.S. market. The company sells to hospitals and emergency departments. It expanded its institutional sales force from 26 to 70 representatives in December 2022 to cover more than 1,700 target hospitals. It reports more than 65 formulary wins and group purchasing organization contracts covering nearly 50% of target beds as of February 28, 2023. Marketing relies on conventions, peer-led speaker programs and digital campaigns. If IGALMI is approved outside the U.S., the company would consider launching through third-party collaborations. For its neuroscience assets, it is evaluating strategic options such as licensing, partnering and co-commercialization.

IGALMI is distributed through a third-party logistics provider and wholesalers. The company competes with antipsychotics, including intramuscular haloperidol and olanzapine, and with benzodiazepines and sublingual antipsychotic tablets used for agitation. Other approved film products include those from BioDelivery Sciences International. The text does not identify the company's headquarters or manufacturers.