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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 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.
About this update from Wockhardt Limited
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 bacteria In 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 tolerated More than 2.8 million antimicrobial-resistant infections occur each year in the U.S., resulting in more than 35,000 deaths1 SHORT 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. "The threat of drug-resistant infections is an escalating crisis, leaving clinicians with fewer tools to treat patients facing these aggressive pathogens. The FDA approval of ZAYNICH is a monumental step forward in validating a new option for these underserved populations," said Dennis Deruelle, MD, FHM, Chief Medical Officer at Wockhardt. "This milestone underscores our commitment to addressing critical unmet needs and offers a profound sense of hope to the families we are working to serve." "This approval is a significant realization of our mission to provide patients with novel antibiotics that help to address one of the most urgent global health threats—antimicrobial resistance,"2 said Dr. Habil F. Khorakiwala, Founder and Chairman of Wockhardt Group. "Furthermore, ZAYNICH is the first New Chemical Entity fully developed and commercialized by an Indian pharmaceutical company to receive an FDA approval, representing a historic milestone not only for Wockhardt, but for the Indian pharmaceutical industry." Zaynich, unlike most beta-lactam and beta-lactamase inhibitor combinations targets multiple penicillin binding protein (PBP 1a/b, 2, 3) simultaneously in most clinically important Gram negatives expressing diverse resistance mechanisms. This unique, multi-target syn...