USFDAJun 17, 2026, 12:37 PM
Spero Therapeutics: FDA Approves First Oral Carbapenem Antibiotic Utebzi
AI Summary
Spero Therapeutics, Inc. and GSK plc announced that the US FDA has approved Utebzi (tebipenem pivoxil), the first and only oral carbapenem antibiotic for adults with complicated urinary tract infections (cUTIs) who have limited or no alternative oral treatment options. The approval, based on the PIVOT-PO trial, marks a significant advancement in treating infections caused by resistant pathogens. Utebzi is expected to be available by the end of 2026, offering an oral alternative to intravenous carbapenems and potentially reducing reliance on hospital care.
Key Highlights
- Spero Therapeutics and GSK announce FDA approval of Utebzi (tebipenem pivoxil) for complicated urinary tract infections (cUTIs).
- Utebzi is the first and only oral carbapenem antibiotic approved in the US for cUTIs with limited or no alternative oral treatment options.
- The approval is based on the PIVOT-PO trial demonstrating non-inferiority to intravenous imipenem-cilastatin.
- The PIVOT-PO trial showed an overall success rate of 58.5% for tebipenem pivoxil vs. 60.2% for imipenem-cilastatin.
- Utebzi is anticipated to be available to US patients by the end of 2026.
- GSK holds exclusive global licensing rights from Spero Therapeutics for tebipenem pivoxil (excluding select Asian territories).
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