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A Multicenter, Double-blind, Randomized, Clinical Study to Assess the Efficacy and Safety of Intravenous S-649266 in Complicated Urinary Tract Infections with or without Pyelonephritis or Acute Uncomplicated Pyelonephritis Caused by Gram-Negative Pathogens in Hospitalized Adults in Comparison with Intravenous Imipenem/Cilastatin

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Trial Profile

A Multicenter, Double-blind, Randomized, Clinical Study to Assess the Efficacy and Safety of Intravenous S-649266 in Complicated Urinary Tract Infections with or without Pyelonephritis or Acute Uncomplicated Pyelonephritis Caused by Gram-Negative Pathogens in Hospitalized Adults in Comparison with Intravenous Imipenem/Cilastatin

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 05 Feb 2026

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At a glance

  • Drugs Cefiderocol (Primary) ; Imipenem/cilastatin
  • Indications Gram-negative infections; Pyelonephritis; Urinary tract infections
  • Focus Registrational; Therapeutic Use
  • Acronyms APEKs-cUTI
  • Sponsors Shionogi

Most Recent Events

  • 08 Jan 2026 According to a Shionogi media release, company has announced that its group company, Shionogi China Co received approval from the National Medical Products Administration (NMPA) of China for cefiderocol for the treatment of complicated urinary tract infections including pyelonephritis caused by Gram-negative bacteria.
  • 02 Apr 2025 According to a Shionogi media release, The Therapeutic Goods Administration (TGA) regulatory authority in Australia accepted the market authorisation application for cefiderocol in December 2024 and the application is under evaluation. The acceptance of this application is based on the results obtained from APEKS-cUTI, CREDIBLE-CR and APEKS-NP.
  • 21 Feb 2025 According to a Shionogi media release, the company announced that JEIL PHARMACEUTICAL CO., LTD its partner in South Korea has obtained marketing approval from the South Korean regulatory authorities for the gram-negative bacterial infection treatment "Fetroja"(cefiderocol) (hereafter "Fetroja"). The approval is based on the data of APEKS-cUTI, CREDIBLE-CR and APEKS-NP studies.

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