Overview
- The FDA approved Utebzi (tebipenem pivoxil) on June 17, 2026 for complicated urinary tract infections, including pyelonephritis, in adults who have limited or no alternative oral treatment options.
- Approval was based on the global Phase 3 PIVOT-PO trial in about 1,690 hospitalized patients, where oral tebipenem achieved a 58.5% overall success rate versus 60.2% for IV imipenem-cilastatin and met the trial’s noninferiority margin.
- The label limits use to infections caused by specified susceptible pathogens (Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae complex, Klebsiella oxytoca, and Enterococcus faecalis) and targets patients without other oral options.
- Prescribers must weigh safety warnings in the FDA label, including common adverse events such as diarrhea and nausea, contraindication with valproic acid or divalproex, and risks of carnitine deficiency in susceptible patients.
- GSK, which holds an exclusive global license from Spero, said Utebzi is expected to be available to U.S. patients by the end of 2026 and stakeholders say the oral option could allow more outpatient care and reduce IV hospital days for resistant or severe cases.