BioXcel submits sNDA for at-home use of IGALMI for agitation in bipolar/schizophrenia

BioXcel Therapeutics, Inc.

Submitted sNDA to FDA on January 14, 2026 for IGALMI in the at-home setting.
IGALMI currently approved only under healthcare provider supervision since April 2022.
No FDA-approved at-home options exist for acute agitation in bipolar disorders or schizophrenia.
Seeking to expand IGALMI's label to cover broader at-home patient population.

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