IGALMI® (dexmedetomidine) - (SERENITY III)

April 1, 2026: BioXcel Therapeutics, Inc. (NASDAQ: BTAI) announced the FDA accepted its supplemental New Drug Application (sNDA) seeking approval of IGALMI (dexmedetomidine) sublingual film for at-home (outpatient) use for the acute treatment of agitation associated with bipolar I/II disorder or schizophrenia. The FDA assigned a PDUFA target action date of November 14, 2026.

The release notes IGALMI is currently administered under healthcare provider supervision for acute agitation in adults with schizophrenia or bipolar I/II disorder; the sNDA aims to expand use to the at-home setting, where the company says there is no FDA-approved treatment option.

The company also describes BXCL501 as its proprietary orally dissolving film formulation of dexmedetomidine, investigational for acute agitation associated with Alzheimer’s dementia and for at-home acute agitation in bipolar disorders or schizophrenia. BXCL501 has FDA Breakthrough Therapy designation for agitation associated with dementia and Fast Track designation for agitation associated with schizophrenia, bipolar disorders, and dementia.