> ## 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.

# Priority Review for Venatorx UTI Drug NDA
- URL: https://www.fdaweb.com/priority-review-for-venatorx-uti-drug-nda/
- Published: 2023-08-15T12:00:00.000Z
- Updated: 2026-09-14T18:50:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155107

FDA has accepted and will give priority review to a Venatorx Pharmaceuticals NDA for cefepime-taniborbactam to treat complicated urinary tract infections (cUTI), including pyelonephritis, in adults. The company [says](https://www.venatorx.com/press-releases/venatorx-pharmaceuticals-announces-fda-acceptance-and-priority-review-of-new-drug-application-for-cefepime-taniborbactam-to-treat-complicated-urinary-tract-infections-cuti-including-pyelonephritis/?ref=fdaweb.com) the agency set 2/22/2024 as the PDUFA action date for the NDA.

It says the NDA is supported by results from the pivotal Phase 3 CERTAIN-1 study that evaluated the efficacy and safety of cefepime-taniborbactam compared to meropenem (Pfizer’s Merrem) in adults with cUTI, including acute pyelonephritis. Venatorx says cefepime-taniborbactam was superior to Merrem for the primary efficacy endpoint and was well-tolerated with no new safety findings.

Cefepime-taniborbactam is described as an investigational intravenous beta-tactam/beta-tactamase inhibitor antibiotic combination being developed to treat cUTIs and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia.