The FDA approved Spero Therapeutics’ oral carbapenem antibiotic tebipenem pivoxil hydrobromide (branded Utebzi) for complicated urinary tract infections, including pyelonephritis. The approval came after four years following an FDA complete response letter, with the agency citing Phase III results showing noninferiority versus intravenous imipenem-cilastatin. In the Phase III program, efficacy endpoints supported the oral regimen’s comparison to standard IV therapy, enabling a pathway to a fully oral option for cUTI. Spero’s development program was supported by a 2022 licensing deal in which GSK acquired global rights outside certain regions covered by original developer Meiji Seika. Utebzi is expected to be available by the end of 2026. The approval highlights ongoing efforts to shift select serious bacterial infections away from IV-first treatment paradigms.