> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Iterum Therapeutics’ Antibiotic OK’d for UTIs
- URL: https://www.fdaweb.com/iterum-therapeutics-antibiotic-okd-for-utis/
- Published: 2024-10-25T12:00:00.000Z
- Updated: 2026-09-14T14:45:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158060

FDA has approved an Iterum Therapeutics NDA for Orlynvah (sulopenem etzadroxil and probenecid) for treating uncomplicated urinary tract infections (uUTIs) caused by the designated microorganisms *Escherichia coli*, *Klebsiella pneumoniae*, or *Proteus mirabilis* in adult women who have limited or no alternative oral antibacterial treatment options.

Approval was based on data from two Phase 3 clinical trials (SURE 1 and REASSURE) that evaluated the safety and efficacy of Orlynvah compared to ciprofloxacin (SURE 1) and Augmentin (REASSURE) in the treatment of adult women with uUTI. “SURE 1 showed superiority to ciprofloxacin in fluoroquinolone resistant infections, while REASSURE showed non-inferiority and statistical superiority to Augmentin in the Augmentin susceptible population,” the company says.

Orlynvah is described as a novel oral penem antibiotic that possesses potent activity against species of Enterobacterales including those that encode extended spectrum beta-lactamase or AmpC-type beta-lactamases that often show resistance to third generation cephalosporins.