Utebzi’s approval gives clinicians the first US oral carbapenem for select cUTI patients, following Phase III data showing comparable results to IV treatment.
Complicated urinary tract infections (cUTIs) can become serious quickly, especially when they spread to the kidneys or involve bacteria that no longer respond well to commonly used antibiotics.
The FDA has approved Utebzi (tebipenem pivoxil) to treat adults with complicated urinary tract infections (cUTIs). These infections can become serious quickly, particularly when bacteria reach the kidneys, a condition known as pyelonephritis, or no longer respond well to standard antibiotics.
Utebzi is approved for adult patients who have limited or no other oral treatment options available.
Utebzi is the first and only oral carbapenem antibiotic approved in the US. Until now, carbapenems have only been available as intravenous (IV) treatments.
In May 2026, the FDA approved Zaynich (cefepime and zidebactam), an IV antibiotic for certain adults with cUTIs, including pyelonephritis.
Utebzi had a long road to approval. After the FDA declined an earlier Spero application in 2022, GSK licensed most global rights to the drug. The newer PIVOT-PO trial was later stopped early because it met its main goal, helping support the resubmitted application that led to approval.
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A New Option for Difficult Infections
Each year, more than 3 million cases of cUTIs are treated across the US. cUTIs are harder to treat because patients are not all the same. The infection may affect different parts of the urinary tract, occur alongside other health issues and involve bacteria that respond differently to antibiotics.
They can also involve bacteria that are difficult to treat. According to GSK, about one-third of cUTI patients in the US are affected by resistant infections.
Utebzi is approved for infections caused by certain susceptible bacteria, including E. coli, Klebsiella pneumoniae and several other common cUTI pathogens.
The Shift from IV to Oral Treatment
Carbapenems are a class of broad-spectrum antibiotics, meaning they can work against many types of bacteria. They are commonly used for severe or resistant bacterial infections. However, IV treatment can be a burden for patients and care teams.
An oral option may allow some appropriate adults to receive treatment outside a hospital-based IV setting, depending on their overall health, the bacteria causing the infection and lab tests showing which antibiotics are likely to work.
Related: Two New Oral Antibiotics, Nuzolvence and Blujepa, Approved for Gonorrhea
Phase III Data Supporting Approval
The FDA based its approval on findings from the Phase III PIVOT-PO trial, a global, randomized, double-blind study that compared oral tebipenem pivoxil with IV imipenem-cilastatin in hospitalized adults with cUTIs, including acute pyelonephritis.
A total of 1,690 patients took part in the study. One group received 600 mg of oral tebipenem pivoxil every six hours, while the other group received 500 mg of IV imipenem-cilastatin every six hours. Treatment lasted for seven to 10 days, with dose adjustments made for patients with reduced kidney function.
The study was designed as a non-inferiority trial. Researchers were not testing whether the oral drug was better, but whether it worked close enough to the established IV treatment while offering the advantage of oral dosing.
Utebzi met this target. At the test-of-cure visit (a specific follow-up appointment used by researchers and doctors to confirm that a treatment has successfully cleared an infection), about 17 days after treatment began, the overall success rate was 58.5% for patients taking oral tebipenem pivoxil compared with 60.2% for patients receiving IV imipenem-cilastatin.
Overall success combined symptom improvement or resolution with lab evidence that the bacteria were cleared or reduced.
Utebzi is expected to reach US patients by the end of 2026.
FAQs
How will doctors know whether Utebzi is appropriate for a patient?
Doctors typically use lab testing to identify the bacteria causing the infection and determine which antibiotics are likely to work. Utebzi is approved only for infections caused by certain susceptible bacteria.
Does Utebzi replace IV antibiotics for all complicated UTIs?
No. Utebzi is approved for certain adults with limited or no alternative oral options. Treatment decisions will still depend on the patient’s condition, infection severity, bacteria involved and susceptibility testing.
Why does oral dosing matter for complicated UTIs?
An oral option may reduce the need for hospital-based or infusion-based IV treatment in appropriate patients. This could make treatment logistics easier for some patients and care teams.
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