GSK’s Utebzi receives US approval for adults with complicated urinary tract infections

GSK and Spero Therapeutics have announced that the US Food and Drug Administration has approved Utebzi, an oral antibiotic indicated for the treatment of complicated urinary tract infections including pyelonephritis, caused by certain susceptible pathogens, in adult patients who have few or no viable oral treatment alternatives. Utebzi holds the distinction of being the first and only oral carbapenem antibiotic to reach this patient population, and its approval flows from a development and exclusive global licensing agreement between GSK and Spero Therapeutics.

Complicated urinary tract infections represent a significant healthcare burden in the US, with over 3 million cases arising each year and treatment failure affecting as many as 34% of patients. Multidrug-resistant pathogens are frequently behind these infections, which generate upwards of 6 billion dollars in annual healthcare expenditure. Carbapenems have long served as the cornerstone treatment for severe or resistant infections, yet prior to this approval they had only been available through intravenous delivery, a limitation that drives up hospital resource use and weighs on patients’ quality of life. Tebipenem pivoxil opens the door to an effective oral alternative that can be taken outside of a hospital environment.

“With antibiotic resistance continuing to rise, patients and healthcare professionals need new treatment options. 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,” said Tony Wood, Chief Scientific Officer, GSK.

“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. 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,” said Dr. Bilal Chughtai, Chief of Urology at Plainview Hospital, Northwell Health and Associate Professor of Urology at the Zucker School of Medicine at Hofstra/Northwell.

“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. We are proud to reach this important milestone. Through our partnership with GSK, we look forward to this much-needed oral treatment option reaching cUTI patients to help reduce the burden of the disease,” said Esther Rajavelu, President and Chief Executive Officer, Spero Therapeutics.

Positive findings from the PIVOT-PO Phase III trial underpin the approval, with the study establishing that tebipenem pivoxil performed on a non-inferior basis compared to intravenous imipenem-cilastatin in hospitalised patients with complicated urinary tract infections including pyelonephritis. The measure used was overall response, a composite of clinical cure and microbiological eradication, assessed at the test of cure visit. Oral tebipenem pivoxil at 600 mg delivered an overall success rate of 58.5% across 446 participants, against 60.2% among 483 participants receiving intravenous imipenem-cilastatin at 500 mg, with an adjusted treatment difference of minus 1.3%.

The safety characteristics of tebipenem pivoxil bore close resemblance to those of imipenem-cilastatin and other agents within the carbapenem class. Diarrhoea and headache were the most frequently reported adverse events, each occurring in at least 3% of patients, and all such events were mild or moderate in severity with none classified as serious.

Utebzi is expected to become available to patients across the US before the close of 2026, adding to the momentum GSK has built across its expanding anti-infectives portfolio. The development of tebipenem pivoxil received partial funding from the US Department of Health and Human Services through the Biomedical Advanced Research and Development Authority under the Administration for Strategic Preparedness and Response.

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Related Topics and Keywords

GSK, urinary tract infections, Utebzi, Utebzi (tebipenem pivoxil), UTI