FDA Approves Oral Utebzi for Complicated UTIs

GSK claims FDA okay for first oral carbapenem antibiotic

GSK has helped top up the antibiotic armamentarium in the US, after securing the first FDA approval for an oral carbapenem, Utebzi.

First Oral Carbapenem Approved for Complicated UTIs

(MedPage Today) -- The FDA approved oral tebipenem pivoxil (Utebzi) as the first oral carbapenem antibiotic to treat complicated urinary tract infections (UTIs), the agency announced on Wednesday. Tebipenem pivoxil is indicated for complicated...

Utebzi (tebipenem pivoxil) approved in the US for adults with complicated urinary tract infections (cUTIs)

PHILADELPHIA--(BUSINESS WIRE)--Jun 17, 2026-

Utebzi: US approves antibiotic to treat urinary tract ​infections

GSK's Utebzi receives FDA approval for complicated urinary tract infections, providing a new oral treatment option.

Utebzi (tebipenem pivoxil) approved in the US for adults with complicated urinary tract ...

First and only oral carbapenem antibiotic approved in the USApproval based on PIVOT-PO trialdemonstrating non-inferiority compared to intravenous treatmentiMore than 3 million cases of cUTIs are treated annually in the USwith a third of patients impacted by resistant infectionsii,iii

FDA approves oral Utebzi for complicated UTIs

The FDA has approved oral Utebzi tablets as a treatment for complicated urinary tract infections, including pyelonephritis, in adults with “limited or no alternative oral treatment options,” the agency announced.Utebzi (tebipenem pivoxil, GSK and Spero Therapeutics) is the first oral carbapenem antibiotic approved for complicated UTIs in the United States. It is the second complicated