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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: 23 Jan 2025

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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

  • 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.
  • 29 Nov 2023 According to a Karuna Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for KarXT for the treatment of schizophrenia in adults based on the data from the EMERGENT program (EMERGENT-1, EMERGENT-2, and EMERGENT-3 trials and in addition long-term safety data from the EMERGENT-4 and EMERGENT-5 trials). The application has been granted a Prescription Drug User Fee Act (PDUFA) date of Sep 26, 2024.

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