FDA approves GSK and Spero's oral carbapenem antibiotic Utebzi

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Utebzi (tebipenem pivoxil) approved in the US for adults with complicated urinary tract infections (cUTIs)

June 17, 2026 4:21 PM EDT

First and only oral carbapenem antibiotic approved in the US Approval based on PIVOT-PO trial demonstrating non-inferiority compared to intravenous treatment1 More than 3 million cases of cUTIs are treated annually in the US2 with up to a third of patients impacted by resistant infections3

PHILADELPHIA--(BUSINESS WIRE)-- GSK plc (LSE/NYSE: GSK) and Spero Therapeutics (Nasdaq: SPRO) today announced that the US Food and Drug Administration (FDA) has approved Utebzi, an oral antibiotic for the treatment of complicated urinary tract... More