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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: 16 Sep 2026

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At a glance

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

Most Recent Events

  • 17 Jul 2026 This trial has been discontinued in Spain due to Sponsor Decision, according to Clinical Trials Information System record.
  • 03 Apr 2026 Planned number of patients changed from 300 to 450.
  • 31 Jul 2025 Status changed from not yet recruiting to recruiting.

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