BioXcel Therapeutics Inc. (NASDAQ: BTAI) announced the U.S. Food and Drug Administration has accepted its supplemental new drug application for IGALMI to treat agitation associated with bipolar disorders or schizophrenia in at-home settings.

The FDA assigned a Prescription Drug User Fee Act target action date of November 14, 2026, for the application review. IGALMI is currently approved for use under healthcare provider supervision in clinical settings.

The supplemental application seeks approval for the first FDA-approved treatment option for acute agitation associated with bipolar disorders or schizophrenia in outpatient settings, according to the company's statement.

"The regulatory acceptance of our sNDA for IGALMI marks a key milestone in our company's mission to improve the lives of millions of patients suffering from agitation associated with bipolar disorders or schizophrenia, with no FDA approved treatment option for this condition in the at-home setting," said Vimal Mehta, chief executive officer of BioXcel Therapeutics.

IGALMI is a dexmedetomidine sublingual film that dissolves under the tongue or behind the lower lip. The medication's safety and effectiveness have not been studied beyond 24 hours from the first dose, and it is not approved for use in children.

BioXcel Therapeutics develops medicines using artificial intelligence and focuses on neuroscience applications. The company's drug development approach uses existing approved drugs combined with data analysis and machine learning algorithms to identify new therapeutic uses.

The information is based on a company press release statement.