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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 Schizophrenia

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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 Schizophrenia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 Jan 2026

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At a glance

  • Drugs Dexmedetomidine (Primary)
  • Indications Agitation
  • Focus Therapeutic Use
  • Acronyms SERENITY I
  • Sponsors BioXcel Therapeutics

Most Recent Events

  • 12 Jan 2026 According to a BioXcel Therapeutics media release, the company is on track to Submit a sNDA for IGALMI this Month.
  • 07 Jan 2026 According to a BioXcel Therapeutics media release, the company plans to submit an sNDA to the USFDA for the approval of IGALMI for at-home use in the acute treatment of agitation associated with bipolar disorders or schizophrenia. Based on the accelerated submission timeline, the company believes IGALMI could be approved for at-home use as early as 2026.
  • 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.

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