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A Phase 2, Randomized, Double-blinded Study to Assess the Safety, Tolerability, and Efficacy of KarXT in Hospitalized Adults With DSM-5 Schizophrenia

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Trial Profile

A Phase 2, Randomized, Double-blinded Study to Assess the Safety, Tolerability, and Efficacy of KarXT in Hospitalized Adults With DSM-5 Schizophrenia

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 01 Dec 2023

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At a glance

  • Drugs Trospium chloride/xanomeline (Primary)
  • Indications Schizophrenia
  • Focus Registrational; Therapeutic Use
  • Acronyms EMERGENT-1
  • Sponsors Karuna Therapeutics
  • Most Recent Events

    • 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.
    • 02 Nov 2023 According to a Karuna Pharmaceuticals media release, data from the study will be presented at upcoming medical congresses in the fourth quarter of 2023.
    • 28 Sep 2023 According to a Karuna Pharmaceuticals media release, based on the EMERGENT-1, EMERGENT-2, EMERGENT-3 in addition to long-term safety data from the ongoing EMERGENT-4 and EMERGENT-5 trials, the company has submitted a New Drug Application (NDA) application to the USA Food and Drug Administration (FDA).
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