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A Prospective Phase 3 Randomized Multi-center Double-blind Study of Efficacy Tolerability & Safety of Oral Sulopenem-etzadroxil/Probenecid vs Ciprofloxacin for Treatment of Uncomplicated Urinary Tract Infections (uUTI) in Adult Women

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Trial Profile

A Prospective Phase 3 Randomized Multi-center Double-blind Study of Efficacy Tolerability & Safety of Oral Sulopenem-etzadroxil/Probenecid vs Ciprofloxacin for Treatment of Uncomplicated Urinary Tract Infections (uUTI) in Adult Women

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 Oct 2024

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At a glance

  • Drugs Sulopenem (Primary) ; Ciprofloxacin
  • Indications Urinary tract infections
  • Focus Registrational; Therapeutic Use
  • Acronyms SURE 1
  • Sponsors Iterum Therapeutics

Most Recent Events

  • 25 Oct 2024 According to an Iterum Therapeutics media release, the U.S. Food and Drug Administration (FDA) has approved new drug application for ORLYNVAH (sulopenem etzadroxil and probenecid) for the treatment of uncomplicated urinary tract infections caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options. This is the first approved indication for ORLYNVAH.
  • 19 Jun 2023 Results (n=1071) characterizing the beta lactamase content of select Enterobacterales isolates recovered from patients enrolled in this trial presented at the ASM Microbe 2023
  • 07 Sep 2022 Results published in the Clinical Infectious Diseases

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