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A Phase 3, Randomized, Double-blind, Double-dummy, Multicenter, Multinational Study to Assess the Efficacy and Safety of Orally Administered Tebipenem Pivoxil Hydrobromide (TBP-PI-HBr) Compared to Intravenously Administered Imipenem-cilastatin in Patients With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)

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Trial Profile

A Phase 3, Randomized, Double-blind, Double-dummy, Multicenter, Multinational Study to Assess the Efficacy and Safety of Orally Administered Tebipenem Pivoxil Hydrobromide (TBP-PI-HBr) Compared to Intravenously Administered Imipenem-cilastatin in Patients With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Dec 2025

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At a glance

  • Drugs Tebipenem pivoxil (Primary) ; Cilastatin; Imipenem; Imipenem/cilastatin
  • Indications Pyelonephritis; Urinary tract infections
  • Focus Registrational; Therapeutic Use
  • Acronyms PIVOT-PO
  • Sponsors Spero Therapeutics

Most Recent Events

  • 13 Nov 2025 According to a Spero Therapeutics media release, company expect to submit the FDA filing this quarter and anticipate regulatory decision in 2H 2026.
  • 21 Oct 2025 According to a Spero Therapeutics media release, GSK plans to work with US regulatory authorities to include the data as part of a filing in Q4 2025.
  • 21 Oct 2025 According to a Spero Therapeutics media release, company presented efficacy and safety results from this study on October 20, 2025, in a late-breaking oral abstract session at IDWeek 2025 in Atlanta, Georgia.

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