USFDAJun 17, 2026, 12:12 PM
GSK's Utebzi (tebipenem pivoxil) approved by US FDA for cUTIs
AI Summary
GSK plc and Spero Therapeutics announced that the US FDA has approved Utebzi (tebipenem pivoxil), an oral antibiotic for complicated urinary tract infections (cUTIs) in adults with limited or no alternative oral treatment options. This marks the first and only oral carbapenem antibiotic approved in the US for cUTIs, including pyelonephritis. The approval is supported by the PIVOT-PO phase III trial, which demonstrated non-inferiority compared to intravenous treatment. Utebzi is expected to be available to US patients by the end of 2026, offering a potential solution to reduce reliance on hospital-based intravenous care for resistant infections.
Key Highlights
- US FDA approved Utebzi (tebipenem pivoxil), an oral antibiotic for complicated urinary tract infections (cUTIs).
- Utebzi is the first and only oral carbapenem antibiotic approved in the US for cUTIs.
- Approval is based on the PIVOT-PO phase III trial, demonstrating non-inferiority to intravenous imipenem-cilastatin.
- The PIVOT-PO trial showed a 58.5% overall success rate for Utebzi compared to 60.2% for IV treatment.
- More than 3 million cases of cUTIs are treated annually in the US, with up to 34% treatment failure.
- Utebzi is anticipated to be made available to US patients by the end of 2026.
Price Impact
More from GSK