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A Pivotal Phase III Clinical Study of Evenamide (NW-3509) in Patients with Schizophrenia Experiencing Worsening of Psychosis on Atypical Antipsychotics

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Trial Profile

A Pivotal Phase III Clinical Study of Evenamide (NW-3509) in Patients with Schizophrenia Experiencing Worsening of Psychosis on Atypical Antipsychotics

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 09 Apr 2021

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At a glance

  • Drugs Evenamide (Primary)
  • Indications Schizophrenia
  • Focus Registrational; Therapeutic Use
  • Sponsors Newron Pharmaceuticals
  • Most Recent Events

    • 01 Apr 2021 According to a Newron Pharmaceuticals media release, the proposed phase III clinical trial program with evenamide targets patients with schizophrenia experiencing worsening of psychosis on atypical antipsychotics (CT profile 288917), and treatment-resistant patients not responding to clozapine. Clozapine is the only antipsychotic approved worldwide for treatment-resistant schizophrenia (CT profile 335685). The program will commence once study 008A results are available.
    • 16 Mar 2021 According to a Newron Pharmaceuticals media release, the company remains on track to initiate the pivotal Phase III program in Q3 2021.
    • 11 Aug 2020 According to a Newron Pharmaceuticals media release, Phase III studies with evenamide will be initiated in Q2 2021.

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