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A Phase 2 Trial to Evaluate the Efficacy and Safety of KarXT when Dosed in Conjunction with Background Antipsychotic Therapy for the Treatment of Psychosis in Patients with Schizophrenia who have an Inadequate Response to Current Standard of Care Therapies

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Trial Profile

A Phase 2 Trial to Evaluate the Efficacy and Safety of KarXT when Dosed in Conjunction with Background Antipsychotic Therapy for the Treatment of Psychosis in Patients with Schizophrenia who have an Inadequate Response to Current Standard of Care Therapies

Status: Planning
Phase of Trial: Phase II

Latest Information Update: 07 Aug 2020

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At a glance

  • Drugs Trospium chloride/xanomeline (Primary)
  • Indications Psychotic disorders
  • Focus Registrational; Therapeutic Use
  • Sponsors Karuna Therapeutics
  • Most Recent Events

    • 07 Aug 2020 New trial record
    • 05 Aug 2020 According to a Karuna Therapeutics media release, data evaluating this study is intended to support a supplemental NDA filing assuming the successful development of KarXT as a monotherapy for the treatment of adults with schizophrenia. The Company plans to initiate this trial following the initiation of the Phase 3 trials within the EMERGENT program.
    • 05 Aug 2020 According to a Karuna Therapeutics media release, the company was previously planned to initiate a phase Ib trial assessing potential Drug-Drug Interactions with a selection of currently marketed antipsychotics in healthy volunteers, but based on multiple considerations, including the evaluation of existing preclinical and clinical data supporting the potential of KarXT to augment traditional antipsychotic drugs, the Company will move forward directly to initiate a Phase 2 trial.
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