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A Phase 3, Randomized, Multicenter, Double-Blind, Double-Dummy, Parallel-Group, Comparative Study to Assess the Efficacy, Safety and Tolerability of Eravacycline Versus Ertapenem in the Treatment of Complicated Intra-Abdominal Infections (cIAI) in Hospitalized Adults

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Trial Profile

A Phase 3, Randomized, Multicenter, Double-Blind, Double-Dummy, Parallel-Group, Comparative Study to Assess the Efficacy, Safety and Tolerability of Eravacycline Versus Ertapenem in the Treatment of Complicated Intra-Abdominal Infections (cIAI) in Hospitalized Adults

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 21 Mar 2023

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At a glance

  • Drugs Eravacycline (Primary) ; Ertapenem
  • Indications Intra-abdominal infections
  • Focus Registrational; Therapeutic Use
  • Sponsors Everest Medicines

Most Recent Events

  • 16 Mar 2023 According to an Everest Medicines media release, the National Medical Products Administration (NMPA) of China has approved its New Drug Application (NDA) for Xerava (eravacycline) for the treatment of complicated intra-abdominal infections (cIAI) in adult patients and plans to launch Xerava in China in Q3, 2023.
  • 07 Oct 2022 According to an Everest Medicines media release, the company announced that the Department of Health of the Hong Kong Special Administrative Region, China, has approved a New Drug Application (NDA) for XERAVA (eravacycline) for the treatment of complicated intra-abdominal infections (cIAI) in adult patients in Hong Kong.
  • 30 Aug 2021 According to an Everest Medicines media release, NDA approval for eravacycline for the treatment in cIAI in China expected in the first half of 2022.

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