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A Phase 3, Multicenter, Two-part Study With a 5-week Double-blind Part (Randomized, Parallel-group, Placebo-controlled) Followed by a 12-week Open-label Extension Part, to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Chinese Adult Subjects With DSM-5 Schizophrenia

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Trial Profile

A Phase 3, Multicenter, Two-part Study With a 5-week Double-blind Part (Randomized, Parallel-group, Placebo-controlled) Followed by a 12-week Open-label Extension Part, to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Chinese Adult Subjects With DSM-5 Schizophrenia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 16 Apr 2025

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At a glance

  • Drugs Trospium chloride/xanomeline (Primary)
  • Indications Schizophrenia
  • Focus Registrational; Therapeutic Use
  • Acronyms UNITE-001
  • Sponsors Karuna Therapeutics

Most Recent Events

  • 10 Apr 2025 Status changed from recruiting to completed.
  • 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).
  • 29 Oct 2024 According to a Zai Lab media release, based on the positive results from this trial company is moving swiftly to submit a new drug application (NDA) to China National Medical Products Administration (NMPA) for KarXT in schizophrenia in early 2025.

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