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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: 05 Jan 2026

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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

  • 22 Dec 2025 According to a Spero Therapeutics media release, The NDA submission triggers a $25 million milestone payment to Spero, expected to be received in Q1 2026.
  • 22 Dec 2025 According to a Spero Therapeutics media release, company announced that its development partner, GSK, filed a New Drug Application (NDA) resubmission to the U.S. Food and Drug Administration (FDA) for tebipenem HBr for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis.
  • 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.

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