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A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)

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Trial Profile

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 14 Aug 2025

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At a glance

  • Drugs Trospium chloride/xanomeline (Primary)
  • Indications Bipolar I disorders
  • Focus Registrational; Therapeutic Use
  • Acronyms BALSAM-2
  • Sponsors Bristol-Myers Squibb

Most Recent Events

  • 29 Jun 2025 Status changed from not yet recruiting to recruiting.
  • 08 May 2025 New trial record

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