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A Prospective, Phase 3, Randomized, Multi-center, Double-blind Study of the Efficacy, Tolerability, and Safety of Oral Sulopenem Etzadroxil/Probenecid Versus Oral Amoxicillin/Clavulanate 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 the Efficacy, Tolerability, and Safety of Oral Sulopenem Etzadroxil/Probenecid Versus Oral Amoxicillin/Clavulanate for Treatment of Uncomplicated Urinary Tract Infections (uUTI) in Adult Women

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 25 Nov 2024

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At a glance

  • Drugs Sulopenem (Primary) ; Amoxicillin/clavulanic acid; Probenecid
  • Indications Urinary tract infections
  • Focus Registrational; Therapeutic Use
  • Acronyms REASSURE
  • 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 Apr 2024 Status changed from active, no longer recruiting to completed.
  • 30 Jan 2024 Iterum expects that the FDA will complete its review and take action six months from the date the FDA receives the resubmitted NDA (or during the fourth quarter of 2024)

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