Wockhardt Limited has received US FDA approval for ZAYNICH (cefepime and zidebactam), a novel intravenous antibiotic for the treatment of adults with complicated urinary tract infections including pyelonephritis. ZAYNICH is indicated for infections caused by susceptible Gram-negative pathogens including Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Enterobacter cloacae complex, and Pseudomonas aeruginosa. The drug had previously been granted Qualified Infectious Disease Product and Fast Track designations by the FDA.
ZAYNICH is the first New Chemical Entity fully developed and commercialised by an Indian pharmaceutical company to receive FDA approval. Wockhardt has a pipeline of six antibiotics at various stages of clinical development and commercialisation, three targeting Gram-negative pathogens and three targeting Gram-positive pathogens. The approval was based on the Phase 3 ENHANCE-1 clinical trial, which enrolled 530 patients across 64 sites in the US, Europe, LATAM, China, and India.
In the trial, ZAYNICH met the primary composite endpoint with a clinical cure and microbiological response rate of 89.0 percent versus 68.4 percent for meropenem, a treatment difference of 20.6 percent. The drug was generally well tolerated, with diarrhoea, hypertension, headache, and hypokalaemia reported as the most common adverse reactions.
ZAYNICH targets multiple penicillin-binding proteins simultaneously, providing bactericidal activity against the most challenging multidrug-resistant Gram-negative bacteria for which treatment options are limited. More than 2.8 million antimicrobial-resistant infections occur each year in the US, resulting in over 35,000 deaths. cUTI accounts for over 600,000 hospitalisations in the US annually.
ZAYNICH was approved by the Drugs Controller General of India on May 27, 2026. Wockhardt has also submitted a Marketing Authorization Application to the European Medicines Agency.
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