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A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Adults With DSM-5 Schizophrenia

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Trial Profile

A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Adults With DSM-5 Schizophrenia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Jan 2026

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At a glance

  • Drugs Trospium chloride/xanomeline (Primary)
  • Indications Schizophrenia
  • Focus Registrational; Therapeutic Use
  • Acronyms EMERGENT-3
  • Sponsors Karuna Therapeutics

Most Recent Events

  • 23 Dec 2025 According to Zai Lab media release, company announced that Chinas National Medical Products Administration (NMPA) approved the New Drug Application (NDA) for COBENFY (xanomeline and trospium chloride) for the treatment of schizophrenia in adults.
  • 17 Jan 2025 According to Zai Lab Limited media release, National Medical Products Administration (NMPA), China has accepted the New Drug Application (NDA) for KarXT for the treatment of schizophrenia in adults based on results from a Phase 1 China Pharmacokinetics (PK) study, the Phase 3 China study (ZL-2701-001) and data from the global EMERGENT clinical program (EMERGENT-1, EMERGENT-2, and EMERGENT-3 trials and in addition long-term safety data from the EMERGENT-4 and EMERGENT-5 trials).
  • 27 Sep 2024 According to Bristol Myers Squibb media release, company announced that the U.S. Food and Drug Administration (FDA) has approved COBENF (xanomeline and trospium chloride), an oral medication for the treatment of schizophrenia in adults.

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