Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

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)

Next Previous
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: Discontinued
Phase of Trial: Phase III

Latest Information Update: 26 Jun 2026

Price :
$35 *
Note:
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

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

  • 17 Jun 2026 According to a Spero Therapeutics media release, company announced that the US Food and Drug Administration (FDA) has approved Utebzi, an oral antibiotic for the treatment of complicated urinary tract infections, This approval is supported by positive results from the PIVOT-PO phase III trial.
  • 13 May 2026 According to a Spero Therapeutics media release, in February 2026, GSK announced that the U.S. Food and Drug Association (FDA) set the Prescription Drug User Fee Act (PDUFA) date to complete the review of the tebipenem HBr NDA as June 18, 2026. The NDA was submitted by GSK in December 2025, supported by results from the Phase 3 PIVOT-PO trial.
  • 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.

You need to be a logged in or subscribed to view this content

Request demo (opens in a new window)
If your organization or you do not have a subscription, try one of the following: If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top