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A Phase 3, Randomized, Double-blind, Active Controlled Noninferiority Study Evaluating the Efficacy, Safety, and Tolerability of Cefepime/VNRX-5133 in Adults With Complicated Urinary Tract Infections (cUTI), Including Acute Pyelonephritis

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Trial Profile

A Phase 3, Randomized, Double-blind, Active Controlled Noninferiority Study Evaluating the Efficacy, Safety, and Tolerability of Cefepime/VNRX-5133 in Adults With Complicated Urinary Tract Infections (cUTI), Including Acute Pyelonephritis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 02 Sep 2024

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At a glance

  • Drugs Cefepime/taniborbactam (Primary) ; Meropenem
  • Indications Bacterial infections; Pyelonephritis; Urinary tract infections
  • Focus Registrational; Therapeutic Use
  • Acronyms CERTAIN-1
  • Sponsors VenatoRx Pharmaceuticals

Most Recent Events

  • 28 Aug 2024 According to an Everest Medicines media release, the company expects to submit NDA of cefepime-taniborbactam for the cUTI indication in mainland China in 2025.
  • 23 Feb 2024 According to a Venatorx Pharmaceuticals media release, the CRL did not identify clinical safety or efficacy issues in the NDA, and the FDA did not request any new clinical trials to support the approval of cefepime-taniborbactam.
  • 23 Feb 2024 According to a Venatorx Pharmaceuticals media release, company announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for cefepime-taniborbactam combination antibiotic under review as a potential treatment for adult patients with complicated urinary tract infections (cUTI), including acute pyelonephritis caused by susceptible gram-negative microorganisms.

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