BioXcel Therapeutics Granted New U.S. Patent For IGALMI Dosing In Acute Agitation, Expanding Protection Through 2043

On July 15, 2025, BioXcel Therapeutics, Inc. announced that the United States Patent and Trademark Office had allowed U.S. Patent Application No. 18/600,419 with claims pertaining to the administration of a single dose of up to 120 mcg of dexmedetomidine in an oromucosal formulation for the treatment of acute agitation associated with schizophrenia or bipolar disorder in certain patient subpopulations where the patient exhibits a maximum allowed QT prolongation of less than six microseconds. The allowed claims mirror the recommended IGALMI dosing regime for treatment of patients meeting this QT prolongation criteria. Once issued, this patent will be eligible for listing in the Orange Book for Igalmi and will be the 14th Orange Book listed patent for Igalmi. This patent will have an expiry date of January 12, 2043, subject to patent term adjustment.