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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy And Safety Study of PRN Dosing of BXCL501 Over A 12 Week Period In Subjects With Agitation Associated With Dementia

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Trial Profile

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy And Safety Study of PRN Dosing of BXCL501 Over A 12 Week Period In Subjects With Agitation Associated With Dementia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 21 Nov 2023

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At a glance

  • Drugs Dexmedetomidine (Primary)
  • Indications Agitation
  • Focus Registrational; Therapeutic Use
  • Acronyms TRANQUILITY II
  • Sponsors BioXcel Therapeutics
  • Most Recent Events

    • 14 Nov 2023 According to a BioXcel Therapeutics media release, R&D expenses were $19.6 million for the third quarter of 2023, compared to $22.1 million for the same period in 2022. The decreased expenses were primarily attributable to a decrease in expenses associated with the BXCL501 SERENITY III and TRANQUILITY II clinical trials.
    • 25 Oct 2023 According to a BioXcel Therapeutics media release, the company announced positive findings from an independent third party audit of the data from this study.
    • 04 Oct 2023 According to a BioXcel Therapeutics media release, type B/ break through meeting scheduled on October 11 in which the company plans to review its TRANQUILITY clinical trial program with the FDA and to discuss the data package required to support submission of an sNDA for the approval of BXC501 for the acute treatment of agitation in mild to moderate dementia patients with probable Alzheimer's disease in assisted living facilities and at-home settings.
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