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The FDA on June 17, 2026 approved Utebzi (tebipenem pivoxil), GSK's oral antibiotic, for adults with complicated urinary tract infections, including pyelonephritis, caused by designated susceptible organisms, who have limited or no alternative oral treatment options.
Tebipenem pivoxil is a prodrug of tebipenem, which the label classes as a penem antibacterial. GSK describes Utebzi as the first and only oral carbapenem approved in the US, and says carbapenems were until now available only intravenously.
Trial 1, which GSK calls PIVOT-PO (NCT06059846), enrolled 1,690 hospitalized patients and compared Utebzi 600 mg every six hours with intravenous imipenem-cilastatin for seven to ten days. Among the 929 patients with a qualifying pathogen at baseline, combined clinical cure and microbiological response at test of cure reached 58.5% on Utebzi and 60.2% on imipenem-cilastatin, which met non-inferiority. In the small subgroup with bacteremia at baseline the rates were 40.6% (13 of 32 patients) and 61.8% (21 of 34).
The label's warnings include hypersensitivity, seizures and Clostridioides difficile infection, and it tells prescribers not to exceed the recommended duration because of a risk of carnitine deficiency.
GSK licensed tebipenem pivoxil from Spero Therapeutics, which shared development, and has since taken over the application. The trial compared Utebzi with an intravenous antibiotic in hospitalized patients, and use is reserved for adults with limited or no alternative oral options in the labeled population.
Sources: FDA prescribing information; Drugs@FDA, NDA 215960; GSK press release; PIVOT-PO (NCT06059846)
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