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A Phase 3, Open-label Extension Study to Assess the Long-term Safety of KarXT for the Treatment of Mania or Mania With Mixed Features in Bipolar-I Disorder (BALSAM-3)

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Trial Profile

A Phase 3, Open-label Extension Study to Assess the Long-term Safety of KarXT for the Treatment of Mania or Mania With Mixed Features in Bipolar-I Disorder (BALSAM-3)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 18 Sep 2025

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At a glance

  • Drugs Trospium chloride/xanomeline (Primary)
  • Indications Bipolar I disorders
  • Focus Adverse reactions
  • Acronyms BALSAM-3
  • Sponsors Bristol-Myers Squibb

Most Recent Events

  • 31 Jul 2025 Status changed from not yet recruiting to recruiting.
  • 22 Apr 2025 New trial record

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