Abstract
Abstract
Purpose
Complicated urinary tract infections (cUTIs), including pyelonephritis, are increasingly challenging when resistant Enterobacterales eliminate conventional oral treatment options. Tebipenem pivoxil (UTEBZI), approved by the US Food and Drug Administration in June 2026, is the first oral carbapenem approved in the United States for selected adults with cUTI. This review evaluates its pharmacology, microbiological activity, efficacy, safety, and potential role in intravenous (IV)-to-oral treatment and antimicrobial stewardship
Methods
A structured narrative review of PubMed/MEDLINE, regulatory documents, clinical-trial reports, guidelines, pharmacokinetic/pharmacodynamic studies, microbiological studies, and relevant oral step-down literature was conducted through 12 August 2026. Priority was given to randomized phase 3 trials, FDA prescribing information, and IDSA guidance
Results
ADAPT-PO and PIVOT-PO demonstrated noninferiority of complete oral tebipenem regimens to IV ertapenem and IV imipenem-cilastatin, respectively, with high clinical cure rates. Tebipenem retains activity against many ESBL- and AmpC-producing Enterobacterales but lacks reliable activity against major carbapenemases. Neither phase 3 trial randomized clinically improving patients after initial IV therapy; therefore, direct randomized evidence for a formal tebipenem step-down strategy is lacking. Important uncertainties include limited bacteremia data, every-six-hour adherence, optimal post-IV duration, cost-effectiveness, microbiome effects, and resistance selection
Conclusion
Tebipenem is an important culture-directed oral option for selected adults with cUTI when narrower effective oral agents are unavailable. Its most defensible early role is replacement of otherwise necessary continued IV carbapenem therapy in carefully selected patients, with source control, susceptibility confirmation, renal doseadjustment, safety screening, duration planning, and stewardship oversight. Dedicated switch, bacteremia, implementation, and resistance-surveillance studies remain needed.