FDA Approval

FDA Approves Cefepime and Zidebactam (Zaynich) for Complicated Urinary Tract Infections Including Pyelonephritis

Anthony Calabro, MA

Key Highlights

  • The FDA approved cefepime and zidebactam (Zaynich) for adults with complicated urinary tract infections, including pyelonephritis, caused by susceptible Gram-negative microorganisms.
  • Approval was based in part on ENHANCE-1, a phase 3 randomized, double-blind, multicenter study comparing cefepime and zidebactam with meropenem in hospitalized adults with complicated urinary tract infection or acute pyelonephritis.
  • In ENHANCE-1, cefepime and zidebactam achieved a composite clinical cure and microbiologic response rate of 89% vs 68.4% with meropenem at the test-of-cure visit.
  • Cefepime and zidebactam previously received FDA Priority Review, Fast Track, and Qualified Infectious Disease Product designations.

On June 1, 2026, Wockhardt Ltd announced that the FDA approved cefepime and zidebactam (Zaynich, Wockhardt), a novel intravenous antibiotic, for the treatment of adults with complicated urinary tract infections, including pyelonephritis, caused by susceptible Gram-negative pathogens.

Cefepime and zidebactam are indicated for infections caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Enterobacter cloacae complex, and Pseudomonas aeruginosa. The cefepime-zidebactam combination targets multiple penicillin-binding proteins and was previously granted Priority Review, Fast Track, and Qualified Infectious Disease Product designations.

The approval was based in part on ENHANCE-1, a phase 3 randomized, double-blind, multicenter study evaluating the efficacy, safety, and tolerability of cefepime and zidebactam compared with meropenem in 530 hospitalized adults with complicated urinary tract infection or acute pyelonephritis across 64 sites in the United States, Europe, Latin America, China, and India. At the primary endpoint, cefepime and zidebactam achieved a composite clinical cure and microbiologic response rate at the test-of-cure visit of 89% vs 68.4% with meropenem, for a treatment difference of 20.6% (95% CI, 12.3-29.5).

“Multidrug-resistant bacterial infections are a substantial burden for patients and the healthcare system, as patients with these infections typically require longer, more intensive care, and are at increased risk of life-threatening complications,” Keith Kaye, MD, MPH, professor of medicine and division chief for infectious diseases at Rutgers Robert Wood Johnson Medical School, said in the press release.

The most common adverse reactions occurring in 2% or more of patients receiving cefepime and zidebactam were diarrhea, hypertension, headache, and hypokalemia.

The prescribing information includes warnings and precautions for hypersensitivity reactions, neurotoxicity, Clostridioides difficile–associated diarrhea, positive direct Coombs tests, prolonged prothrombin time, development of drug-resistant bacteria, and interactions with urine glucose testing. Cefepime and zidebactam are contraindicated in patients with a known history of serious hypersensitivity to cefepime, zidebactam, or other beta-lactam antibacterial drugs.

Reference
Wockhardt. Wockhardt receives U.S. FDA approval for ZAYNICH™ (cefepime and zidebactam), a novel intravenous antibiotic for the treatment of adult patients with complicated urinary tract infection including pyelonephritis. PR Newswire. Published June 1, 2026. Accessed June 11, 2026. https://www.prnewswire.com/news-releases/wockhardt-receives-us-fda-approval-for-zaynich-cefepime-and-zidebactam-a-novel-intravenous-antibiotic-for-the-treatment-of-adult-patients-with-complicated-urinary-tract-infection-including-pyelonephritis-302786691.html