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# FDA OKs Meitheal’s Antibiotic for Urinary Tract Infections
- URL: https://www.fdaweb.com/fda-oks-meitheals-antibiotic-for-urinary-tract-infections/
- Published: 2025-11-04T12:00:00.000Z
- Updated: 2026-09-14T15:25:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160160

FDA has approved a Meitheal Pharmaceuticals NDA for Contepo (fosfomycin) for injection for treating adults with complicated urinary tract infections (cUTI), including acute pyelonephritis, caused by susceptible *Escherichia coli* and *Klebsiella pneumoniae*.

Fosfomycin is described by the company as a novel epoxide antibacterial and the only intravenous antibiotic of its kind approved in the U.S. It acts at an early stage of bacterial cell wall synthesis — earlier than β-lactam antibiotics — blocking the first committed step and effectively killing the bacteria, it says. The drug has no known cross-resistance with other antibiotic classes, according to Meitheal.

Approval was based on data from the Phase 2/3 ZEUS (ZTI-01) trial, which compared intravenous fosfomycin with piperacillin/tazobactam in hospitalized patients with cUTI. The company says the study showed noninferiority for Contepo on the primary endpoint of overall success — defined as clinical cure and microbiologic eradication — achieved by 63.5% of patients treated with fosfomycin versus 55.6% with piperacillin/tazobactam.

The treatment was generally well tolerated, it says, with the most common side effects including elevated liver enzymes, low potassium, neutropenia, nausea, and diarrhea.