May 30, 2026 – Wockhardt announced that the U.S. Food and Drug Administration (FDA) has approved Zaynich (cefepime and zidebactam), a novel intravenous antibiotic for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, in adults caused by susceptible Gram-negative pathogens. Zaynich had previously received Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA.
Unique Mechanism: Multi-Target Penicillin-Binding Protein Synergy
Zaynich is a fixed-dose combination of the fourth-generation cephalosporin cefepime and zidebactam, which act synergistically against the most challenging multidrug-resistant Gram-negative bacteria. Unlike most other beta-lactam combination products, Zaynich simultaneously targets multiple penicillin-binding proteins (PBP1a/b, 2, and 3). This unique multi-target synergy enables it to kill drug-resistant Gram-negative bacteria for which current treatment options are extremely limited.
Phase 3 Clinical Data: ENHANCE-1 Study Met Primary Endpoint
In the Phase 3 ENHANCE-1 clinical trial, Zaynich demonstrated superior efficacy compared to meropenem for the composite endpoint of overall clinical cure and microbiological response at the end-of-treatment visit: 89.0% vs. 68.4%. The treatment difference was 20.6% (95% CI: 12.3, 29.5). Zaynich was generally well tolerated.
Expert and Company Statements: Addressing the Antimicrobial Resistance Crisis
Dr. Dennis Deruelle, FHM, Chief Medical Officer at Wockhardt, said: "The threat of resistant infections is a growing crisis, and clinicians have fewer and fewer tools to address these aggressive pathogens. The FDA approval of Zaynich is a major step forward in providing a new option for these underserved populations. This milestone underscores our commitment to addressing critical unmet needs and brings profound hope to the families we serve."
Dr. Habil F. Khorakiwala, Founder and Chairman of the Wockhardt Group, said: "This approval is a major realization of our mission – to deliver novel antibiotics to patients and help combat one of the world's most urgent health threats – antimicrobial resistance. Furthermore, Zaynich is the first FDA-approved new chemical entity to be fully discovered, developed, and commercialized by an Indian pharmaceutical company – a historic milestone not just for Wockhardt but for the Indian pharmaceutical industry."
Dr. Keith Kaye, M.D., M.P.H., Professor of Medicine and Chief of the Division of Infectious Diseases at Rutgers Robert Wood Johnson Medical School, noted: "Multidrug-resistant bacterial infections place a heavy burden on patients and healthcare systems because those infected often require longer, more intensive treatments and are at greater risk of life-threatening complications. The need for new antibiotics active against these resistant pathogens remains. We are pleased that this approval means patients in the US and around the world will soon have access to a uniquely anticipated new option."
Disease Burden: Complicated Urinary Tract Infections and Resistance
Each year, over 600,000 hospitalizations in the United States are attributed to complicated urinary tract infections. An increasing number of cUTIs are caused by antimicrobial-resistant bacteria, including multidrug-resistant strains, which are a major cause of bloodstream infections associated with significant morbidity, mortality, and a heavy burden on healthcare systems.
Over 2.8 million antimicrobial-resistant infections occur in the United States each year, resulting in more than 35,000 deaths.
About the ENHANCE-1 Pivotal Trial
The FDA approval was based in part on results from the ENHANCE-1 study, a Phase 3, randomized, double-blind, multicenter study evaluating the efficacy, safety, and tolerability of Zaynich compared to meropenem in hospitalized adults with cUTI or acute pyelonephritis (AP). The study enrolled 530 patients across 64 centers in the United States, Europe, Latin America, China, and India.
