Wockhardt has secured U.S. Food and Drug Administration’s (USFDA) approval for 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 USFDA. ZAYNICH is the first New Chemical Entity fully developed and commercialized by an Indian pharmaceutical company to receive an USFDA approval.
The USFDA approval was based, in part, on the results from ENHANCE-1, a Phase 3, randomized, double-blind, multicenter study which evaluated the efficacy, safety and tolerability of ZAYNICH compared with meropenem in the treatment of hospitalized adults with cUTI or acute pyelonephritis (AP). ZAYNICH demonstrated efficacy at the primary endpoint, achieving a composite clinical cure and microbiological response rate of 89.0% versus 68.4% for meropenem Treatment difference 20.6% (95% CI; 12.3, 29.5). ZAYNICH was generally well tolerated in the phase 3 study. The study enrolled 530 patients from the U.S., Europe, LATAM, China and India, and spanned across 64 sites.
ZAYNICH was approved by the Drugs Controller General of India (DCGI) on May 27, 2026. The company has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency.
Wockhardt is a research based Global Pharmaceutical and Biotech company.
