Trial Profile

A Phase III Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Determine Efficacy and Safety of BXCL501 In Agitation Associated With Schizophrenia

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 10 Oct 2023

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At a glance

04 Oct 2023 According to a BioXcel Therapeutics media release, the Company will review its SERENITY III program with the FDA on November 8, 2023 in a Type C meeting and plans to discuss the data package required to support submission of an sNDA seeking approval of BXCL501 for the acute treatment of agitation associated with bipolar disorders I and II and schizophrenia in the at-home setting.
03 Oct 2022 Results published in the Journal of Clinical Psychiatry
24 Aug 2022 to use the evidence-based medicine metrics of number needed to treat, number needed to harm, and likelihood to be helped or harmed to appraise the clinical efficacy and tolerability of sublingual dexmedetomidine

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