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BXCL501 FDA Approval Status

FDA Approved: No
Brand name: BXCL501
Generic name: dexmedetomidine
Company: BioXcel Therapeutics, Inc.
Treatment for: Agitation

BXCL501 (dexmedetomidine) is an orally dissolving thin film formulation of the approved alpha2-adrenergic agonist dexmedetomidine in development for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II.

Development Timeline for BXCL501

DateArticle
Mar 11, 2021BioXcel Therapeutics Submits New Drug Application to U.S. Food and Drug Administration for BXCL501 for the Acute Treatment of Agitation Associated with Schizophrenia and Bipolar Disorders
Dec 27, 2018BioXcel Therapeutics Receives FDA Fast Track Designation for BXCL501 for Acute Treatment of Agitation

Further information

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