FDA Approves Oral Utebzi Antibiotic for Complicated Urinary Tract Infections

MONDAY, June 22, 2026 (HealthDay News) — The U.S. Food and Drug Administration has approved Utebzi (tebipenem pivoxil), an oral antibiotic, for the treatment of complicated urinary tract infections (cUTIs).

Utebzi is indicated for cUTIs, including pyelonephritis, in adult patients who have limited or no alternative oral treatment options.

The approval is based upon results from the PIVOT-PO phase 3 trial, which showed Utebzi to be noninferior to intravenous imipenem-cilastatin in hospitalized patients with cUTI, including for pyelonephritis. Results were based on the overall response, which was a composite of clinical cure plus microbiological eradication. Oral Utebzi (600 mg) demonstrated a 58.5 percent overall success rate (261 of 446 participants) versus 60.2 percent (291 of 483 participants) for intravenous imipenem-cilastatin (500 mg).  The safety profile of Utebzi was generally similar to other carbapenem antibiotics, with the most commonly reported adverse events (in ≥3 percent of patients) being diarrhea and headache — all mild or moderate.

“With antibiotic resistance continuing to rise, patients and health care professionals need new treatment options,” Tony Wood, chief scientific officer at GSK, said in a statement. “The approval of Utebzi provides the first and only oral carbapenem antibiotic for appropriate adults with complicated UTIs, a solution that could help reduce reliance on hospital-based intravenous care and support efforts to address resistant infections.”

Approval of Utebzi was granted to GSK.

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