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Phase II clinical trial of TNX-601 CR for major depressive disorder

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Trial Profile

Phase II clinical trial of TNX-601 CR for major depressive disorder

Status: Planning
Phase of Trial: Phase II

Latest Information Update: 06 Oct 2022

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At a glance

  • Drugs Naloxone/tianeptine (Primary)
  • Indications Major depressive disorder
  • Focus Therapeutic Use
  • Sponsors Tonix Pharmaceuticals Holding Corp

    • Most Recent Events

    • 03 Oct 2022 According to a Tonix Pharmaceuticals Holding Corp media release, U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application to support a Phase 2 clinical trial with TNX-601 ER, a once-daily formulation of tianeptine as a potential treatment for major depressive disorder (MDD).
    • 14 Mar 2022 According to a Tonix Pharmaceuticals Holding Corp media release, this study is expected to begin in the first quarter of 2023.
    • 09 Aug 2021 According to the Tonix Pharmaceuticals Inc media release, this trial is expected to initiate in the first half of 2022 pending results of nonclinical toxicology studies and IND clearance.
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