BioXcel Therapeutics submits supplemental new drug application to US FDA for Igalmi label expansion in the at home setting

BioXcel Therapeutics

20 January 2026 - BioXcel Therapeutics today announced it submitted a supplemental new drug application to the US FDA for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at home (outpatient) setting with Igalmi. 

The supplemental new drug application was submitted on 14 January 2026.

Read BioXcel Therapeutics press release

Michael Wonder

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Michael Wonder

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Medicine , US , Dossier , Registration