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

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

SHORT HILLS, N.J., June 1, 2026

ZAYNICH is a multi- penicillin-binding protein targeting combination of the 4th generation cephalosporin cefepime and zidebactam working synergistically against the most challenging multidrug-resistant Gram-negative bacteriaIn the Phase 3 ENHANCE-1 clinical trial, ZAYNICH demonstrated higher combined clinical cure and microbiologic response (composite endpoint) at the test of cure (TOC) visit versus meropenem, 89.0% vs 68.4% respectively and was generally well toleratedMore than 2.8 million antimicrobial-resistant infections occur each year in the U.S., resulting in more than 35,000 deaths1SHORT HILLS, N.J., June 1, 2026 /PRNewswire/ -- Wockhardt today announced that the U.S. Food and Drug Administration (FDA) has approved ZAYNICH™ (cefepime and zidebactam), a novel intravenous antibiotic for the treatment of adults with complicated urinary tract infections (cUTI), including pyelonephritis, caused by susceptible Gram-negative pathogens. ZAYNICH previously received Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA.