A Phase 3, Randomized, Double-Blind, Double-Dummy, Multicenter, Prospective Study to Assess the Efficacy and Safety of Eravacycline Compared With Ertapenem in Complicated Intra-abdominal Infections

Trial Profile

A Phase 3, Randomized, Double-Blind, Double-Dummy, Multicenter, Prospective Study to Assess the Efficacy and Safety of Eravacycline Compared With Ertapenem in Complicated Intra-abdominal Infections

Completed
Phase of Trial: Phase III

Latest Information Update: 27 Feb 2018

At a glance

  • Drugs Eravacycline (Primary) ; Ertapenem
  • Indications Bacterial infections; Intra-abdominal infections
  • Focus Registrational; Therapeutic Use
  • Acronyms IGNITE 1
  • Sponsors Tetraphase Pharmaceuticals
  • Most Recent Events

    • 27 Feb 2018 According to a Tetraphase Pharmaceuticals media release, the FDA has completed its initial 60-day review of the New Drug Application (NDA) for eravacycline for the treatment of complicated intra-abdominal infections (cIAI), and determined that the application is sufficiently complete to permit a substantive review. The PDUFA (Prescription Drug User Fee Act) goal date for the completion of the FDA's review of the eravacycline NDA is set for 28 Aug 2018.
    • 02 Jan 2018 According to a Tetraphase Pharmaceuticals media release, based on the data from IGNITE1 and IGNITE4 studies the company has submitted New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for intravenous (IV) eravacycline for the treatment of complicated intra-abdominal infections (cIAI).
    • 17 Aug 2017 According to a Tetraphase Pharmaceuticals media release, based on the data from this study, the Marketing Authorization Application (MAA) for IV eravacycline for the treatment of complicated intra-abdominal infections (cIAI) has been submitted and was validated by the European Medicines Agency (EMA).
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