FDA Approves Cefepime-Zidebactam Injection

Phase 3 ENHANCE-1 results showed higher composite clinical cure and microbiologic response rates with cefepime-zidebactam vs meropenem in hospitalized adults with complicated urinary tract infection or acute pyelonephritis.

By
Kathryn Wighton
June 3, 2026
2 min

Conexiant

Overview

The FDA has approved cefepime and zidebactam for treating adults with complicated urinary tract infections (cUTIs), showing a clinical cure and microbiologic response rate of 89%.

Background

Complicated urinary tract infections (cUTIs) are a significant health concern, leading to over 600,000 hospitalizations annually in the US. The rise of multidrug-resistant bacterial infections poses a substantial burden on healthcare systems.

Data Highlights

Parameter	Cefepime-Zidebactam	Meropenem
Composite clinical cure and microbiologic response rate	89%	68%

Key Findings

Cefepime and zidebactam approved for cUTIs and pyelonephritis caused by susceptible Gram-negative pathogens.
Approval based on the phase 3 ENHANCE-1 trial involving 530 patients across multiple countries.
Combination therapy achieved a significantly higher response rate compared to meropenem.
Common adverse reactions include diarrhea, headache, hypertension, and hypokalemia.
FDA granted Priority Review, Fast Track, and Qualified Infectious Disease Product designations for this treatment.

Clinical Implications

Awareness of potential adverse reactions and appropriate dosing adjustments for renal impairment is essential for safe administration.

Conclusion

The approval of cefepime and zidebactam marks a significant development in the fight against multidrug-resistant infections, offering hope for improved patient outcomes in complicated urinary tract infections.