FDA approved Utebzi, an oral carbapenem antibiotic developed by GSK in partnership with Spero Therapeutics, for the treatment of complicated urinary tract infections (cUTI) including pyelonephritis in adult patients with limited or no alternative oral treatment options.

The approval addresses a significant gap in the treatment of cUTIs, which affect more than 3 million patients in the U.S. annually and carries a treatment failure rate of up to 34%.¹ Until now, carbapenems have only been available through intravenous administration, requiring hospital-based care and increasing resource burden on both patients and healthcare systems.

What is Utebzi and how does it work?

Utebzi (tebipenem pivoxil) is an oral carbapenem antibiotic indicated for cUTIs caused by certain susceptible pathogens, specifically Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae species complex, Klebsiella oxytoca, and Enterococcus faecalis.¹ The treatment is administered as a 600 mg oral dose every six hours for seven to ten days, with dose adjustments for patients with reduced renal function.¹

As a carbapenem, it targets the same class of resistant and severe infections previously addressable only in inpatient settings, while offering the potential for treatment in outpatient environments.

The drug received both Qualified Infectious Disease Product and Fast Track designations from FDA, and its development was supported in part by federal funding from BARDA under the U.S. Department of Health and Human Services.¹

"The FDA approval of tebipenem pivoxil marks the culmination of more than a decade of dedication from our team, partners, and, most importantly, the patients who placed their trust in this program," said Esther Rajavelu, president and CEO of Spero Therapeutics.

What did the PIVOT-PO trial show?

Utebzi’s approval is based on results from the Phase III Pivot-PO trial, a global, randomized, double-blind, pivotal non-inferiority study that enrolled 1,690 hospitalized adult patients with cUTIs including acute pyelonephritis.² Patients were randomized 1:1 to receive oral tebipenem pivoxil or intravenous imipenem-cilastatin.

The primary endpoint was composite response, combining per-patient clinical cure and microbiological eradication, at the test-of-cure visit approximately 17 days from first dose. Tebipenem pivoxil achieved a 58.5% overall success rate (261/446 participants) compared with 60.2% for imipenem-cilastatin (291/483 participants), yielding an adjusted treatment difference of −1.3% (95% CI: −7.5%, 4.8%) within the prespecified non-inferiority margin of −10%.²

The safety profile was similar to that of imipenem-cilastatin and other carbapenems. The most frequently reported adverse events, occurring in 3% or more of patients, were diarrhea and headache, all of which were mild or moderate and non-serious.²

"With antibiotic resistance continuing to rise, patients and healthcare professionals need new treatment options," said Tony Wood, chief scientific officer at GSK. "The approval of Utebzi provides the first and only oral carbapenem antibiotic for appropriate adults with complicated UTIs, a solution that could help reduce reliance on hospital-based intravenous care and support efforts to address resistant infections."

Why is this approval significant?

Intravenous carbapenem therapy requires hospital admission or infusion center access, placing logistical and financial burdens on patients and the healthcare system alike. An effective oral alternative administered at home could reduce hospitalization rates and associated costs for a condition that already accounts for billions in annual healthcare expenditure.

"For patients with complicated urinary tract infections and their caregivers, this approval is a major milestone as today's standard of care places a serious burden on them and hospitals," said Dr. Bilal Chughtai, chief of urology at Plainview Hospital, Northwell Health and associate professor of urology at the Zucker School of Medicine. "A new effective oral treatment offering an alternative option to intravenous care has the potential to enable more treatment in outpatient settings."

Sources

1. Utebzi (tebipenem pivoxil) approved in the US for adults with complicated urinary tract infections (cUTIs) GSK June 17, 2026 https://www.gsk.com/en-gb/media/press-releases/utebzi-tebipenem-pivoxil-approved-in-the-us-for-adults-with-complicated-urinary-tract-infections-cutis/
2. A Study of Oral Tebipenem Pivoxil Hydrobromide (TBP-PI-HBr) Compared to Intravenous Imipenem-cilastatin in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) (PIVOT-PO) National Library of Medicine March 10, 2026 https://clinicaltrials.gov/study/NCT06059846