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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Oct 2023

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At a glance

  • Drugs Dexmedetomidine (Primary)
  • Indications Agitation; Bipolar disorders; Bipolar I disorders; Bipolar II disorders
  • Focus Registrational; Therapeutic Use
  • Acronyms SERENITY II
  • Sponsors BioXcel Therapeutics

Most Recent Events

  • 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 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.
  • 24 Aug 2022 Results of post hoc analysis from NCT04268303 and NCT04276883 using 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, published in the Advances in Therapy
  • 10 Jun 2022 Results (n=758) of a post hoc pooled analysis of dexmedetomidine oral dissolving films assessing PANSS-Excited component items in acute agitation with schizophrenia or bipolar disorder patients using data from two clinical studies: SERENITY I and SERENITY II presented at the 175th Annual Meeting of the American Psychiatric Association

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