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An Open-label Study to Assess the Long-term Safety, Tolerability, and Efficacy of KarXT in De Novo Subjects With DSM-5 Schizophrenia

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Trial Profile

An Open-label Study to Assess the Long-term Safety, Tolerability, and Efficacy of KarXT in De Novo Subjects 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 Adverse reactions; Registrational
  • Acronyms EMERGENT-5
  • 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).
  • 31 Oct 2024 Results presented in a Bristol Myers Squibb media release
  • 31 Oct 2024 According to a Bristol Myers Squibb media release, new topline results from the Phase 3 EMERGENT-4 and EMERGENT-5 open-label trials, were presented presented at the 2024 Psych Congress, taking place from Oct 29 - Nov 2, 2024 in Boston, MA.

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