FDA Approval

FDA Approves Utebzi as First Oral Carbapenem Therapy for Complicated Urinary Tract Infections in Adults

Key Highlights

  • Tebipenem pivoxil (Utebzi) is the first oral carbapenem therapy approved for complicated urinary tract infections, including pyelonephritis.
  • The approval applies to adults with infections caused by several susceptible microorganisms and limited or no alternative oral treatment options.
  • In a global randomized noninferiority trial, pivoxil demonstrated comparable effectiveness to imipenem-cilastatin.
  • Common adverse events included diarrhea, headache, nausea, abdominal pain, increased liver enzymes, and Clostridioides difficile infection.

On June 17, the FDA approved tebipenem pivoxil (Utebzi; GlaxoSmithKline, plc) tablets for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis, caused by susceptible microorganisms in adults with limited or no alternative oral treatment options. Tebipenem pivoxil is the first oral carbapenem therapy approved for this indication.

The approval was supported by data from a global, randomized, double-blind, noninferiority trial (NCT06059846) in adults with cUTI, including pyelonephritis. In the trial, 1,690 hospitalized patients were randomly assigned to receive tebipenem pivoxil 600 mg orally every 6 hours or imipenem-cilastatin 500 mg intravenously every 6 hours for 7 to 10 days. A total of 929 patients were included in the intent-to-treat population. Efficacy was assessed as a composite of clinical cure, defined as the resolution of signs and symptoms of infection, and microbiological response, defined as a reduction in baseline pathogens, at a follow-up visit. Composite response rates indicated that tebipenem pivoxil’s effectiveness was comparable to that of imipenem-cilastatin.

The most common adverse events associated with tebipenem pivoxil were diarrhea, headache, nausea, abdominal pain, increased liver enzymes, and Clostridioides difficile infection.

The FDA noted that patients with allergic reactions to tebipenem pivoxil or other beta-lactam antibacterials should not take the medication. It should also not be used in patients with primary or secondary carnitine deficiency or inborn errors of metabolism that may result in clinically significant carnitine deficiency.

The recommended regimen evaluated in the pivotal trial was tebipenem pivoxil 600 mg orally every 6 hours for 7 to 10 days.

Reference
US Food and Drug Administration. FDA approves first oral carbapenem therapy for complicated urinary tract infections. Published June 17, 2026. Accessed June 18, 2026. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-oral-carbapenem-therapy-complicated-urinary-tract-infections