FDA approves tebipenem pivoxil for complicated urinary tract infections

On June 17, 2026, the FDA approved tebipenem pivoxil (Utebzi), for complicated urinary tract infections (cUTI), including pyelonephritis, caused by several susceptible microorganisms in adult patients who have limited or no alternative oral treatment options.^1,2

This decision marks the first approval of an oral carbapenem therapy in the US.

“[Up until now,] the only carbapenems we had to treat multi-drug resistant bugs were IV formulations. Anyone with a complicated UTI that had resistance to our usual oral antibiotics and was symptomatic was required to either be hospitalized for intravenous antibiotics or required a PICC line or infusion center, which is time consuming and costly,” explained Debra L. Fromer, MD, of Hackensack Meridian Health, in correspondence with Urology Times^®. “The advent of a new oral carbapenem reduces the strain on the health care system by being able to shorten length of stays and being able to treat patients in an outpatient setting.”

Data on tebipenem pivoxil

The approval is supported by results from the phase 3 PIVOT-PO trial (NCT06059846), which met its primary end point by showing that tebipenem pivoxil was noninferior to imipenem-cilastatin in regard to the overall response rate (composite of clinical cure plus microbiological eradication) at the test-of-cure (TOC) visit in hospitalized adult patients with cUTI.

The trial was stopped early for efficacy following an interim analysis of the data in May 2025. Results from the study were presented as a late-breaking abstract at IDWeek 2025.³

In total, the global, double-blind trial had enrolled 1690 patients with cUTI, including acute pyelonephritis. Patients in the trial were randomly assigned 1:1 to receive 600 mg tebipenem pivoxil orally every 6 hours or 500 mg intravenous imipenem-cilastatin every 6 hours for a total of 7 to 10 days. The trial’s primary end point was overall response rate (consisting of a composite score of clinical cure plus microbiological eradication) at the TOC visit (about 17 days from first dose administration of study drug) in patients with qualifying pathogens susceptible to imipenem.

Data showed an overall success rate of 58.5% among patients who received tebipenem pivoxil compared with a rate of 60.2% among those who received imipenem-cilastatin (adjusted treatment difference: -1.3%; 95% CI, -7.5% to 4.8%).

Clinical cure (absence of symptoms) at the TOC visit was achieved in 93.5% of patients in the tebipenem pivoxil cohort vs 95.2% in the imipenem-cilastatin cohort (adjusted treatment difference, -1.6%; 95% CI, -4.7% to 1.4%). The rates of microbiological response at the TOC visit were 60.3% in the tebipenem pivoxil arm compared with 61.3% in the imipenem-cilastatin arm (adjusted treatment difference, -0.8%; 95% CI, -6.9% to 5.3%).

In patients with infections caused by antimicrobial-resistant Enterobacterales, clinical and microbiological response rates were consistent with what was observed in the overall population.

The safety profile for tebipenem pivoxil was also consistent with that of other carbapenem antibiotics. The most common adverse events in the trial were diarrhea and headache, all of which were mild to moderate and non-serious.

“For patients with cUTIs and their caregivers, this approval is a major milestone as today’s standard of care places a serious burden on them and hospitals,” said Bilal Chughtai, MD, chief of urology at Plainview Hospital, Northwell Health and associate professor of urology at the Zucker School of Medicine at Hofstra/Northwell, in a news release from GSK.² “A new effective oral treatment offering an alternative option to intravenous care has the potential to enable more treatment in the outpatient settings with the ambition to improve their experience.”

REFERENCES

1. FDA approves first oral carbapenem therapy for complicated urinary tract infections. News release. US Food & Drug Administration. June 17, 2026. Accessed June 17, 2026. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-oral-carbapenem-therapy-complicated-urinary-tract-infections

2. Utebzi (tebipenem pivoxil) approved in the US for adults with complicated urinary tract infections (cUTIs). News release. GSK. June 17, 2026. Accessed 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/

3. PIVOT-PO phase 3 data show tebipenem HBr's potential as the first oral carbapenem antibiotic for patients with complicated urinary tract infections (cUTIs). News release. Spero Therapeutics. October 21, 2025. Accessed June 18, 2026. https://s3.amazonaws.com/b2icontent.irpass.cc/2748/rl158673.pdf