FDA approves Utebzi, first oral carbapenem for complicated UTI

FDA has approved Utebzi (tebipenem pivoxil) tablets for adults with complicated UTIs, including pyelonephritis, caused by susceptible bacteria when patients have limited or no alternative oral treatment options.

The approval is clinically important because resistant complicated UTIs often require IV carbapenem therapy and hospital-based care. As the first oral carbapenem approved in the US, Utebzi may give clinicians a new oral step-down or outpatient treatment option for selected adults who are clinically stable but would otherwise need continued IV treatment.

Utebzi is active against susceptible Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae species complex, Klebsiella oxytoca, and Enterococcus faecalis. Use should be guided by culture and susceptibility results whenever possible, given the importance of preserving carbapenem activity in the setting of antimicrobial resistance.

The FDA decision was based on the phase 3 PIVOT-PO trial, a global, randomized, double-blind, double-dummy noninferiority study in 1,690 hospitalized adults with complicated UTI, including pyelonephritis. Patients received oral tebipenem pivoxil 600 mg every 6 hours or IV imipenem-cilastatin 500 mg every 6 hours for 7 to 10 days.

Efficacy was assessed as a composite of clinical cure and microbiologic response at a follow-up visit. Utebzi was comparable to IV imipenem-cilastatin, with overall response rates of 58.5% and 60.2%, respectively, in patients with qualifying susceptible pathogens.

The most common adverse events included diarrhea, headache, nausea, abdominal pain, increased liver enzymes, and Clostridioides difficile infection. Utebzi should not be used in patients with allergic reactions to Utebzi or other beta-lactam antibacterials, or in patients with primary or secondary carnitine deficiency or inborn errors of metabolism that may result in clinically significant carnitine deficiency.

“For patients with complicated urinary tract infections and their caregivers, this approval is a major milestone as today’s standard of care places a serious burden on them and hospitals,” said Bilal Chughtai, MD, chief of urology at Plainview Hospital, Northwell Health, and associate professor of urology at the Zucker School of Medicine at Hofstra/Northwell. “A new effective oral treatment offering an alternative option to intravenous care has the potential to enable more treatment in outpatient settings and improve their experience.”

Utebzi is expected to become available to US patients by the end of 2026.

Sources: FDA. 2026 June 17. [Press release]. FDA approves first oral carbapenem therapy for complicated urinary tract infections

GSK. 2026 June 17. [Press release]. Utebzi (tebipenem pivoxil) approved in the US for adults with complicated urinary tract infections (cUTIs)