Wockhardt Ltd. has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (US FDA) for its novel antibacterial agent, Zidebactam-Cefepime injection (WCK 5222), marketed as Zaynich™. The submission seeks approval for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, with or without concurrent bacteremia caused by Gram-negative bacteria, including multidrug-resistant strains.
Globally, more than eight million cases of complicated urinary tract infections are reported annually in the US and EU, underscoring the significant burden of Gram-negative infections. This milestone marks the first NDA submission to the US FDA for a drug fully discovered and developed by an Indian pharmaceutical company, highlighting Wockhardt’s contribution to global pharmaceutical innovation.
Zidebactam-Cefepime represents a first-in-class β-lactam enhancer and β-lactam combination, offering a novel mechanism of action to address infections unresponsive to existing therapies. Clinical and non-clinical studies have demonstrated its potent activity against multi-drug resistant (MDR) and extreme drug-resistant (XDR) Gram-negative pathogens, including strains harboring NDM carbapenemases and PBP mutations. A Phase II study further validated its efficacy against a broad spectrum of carbapenem-resistant infections.
The NDA submission follows the successful completion of the Phase III ENHANCE 1 global clinical trial, conducted across 64 sites in India, the United States, Bulgaria, Estonia, Lithuania, Poland, Slovakia, Mexico, and China. The development program is supported by a comprehensive clinical package, including nine Phase I studies in the US and China, a Phase II study in India, and the pivotal Phase III trial evaluating efficacy in cUTI, including pyelonephritis.
Zidebactam-Cefepime has received Qualified Infectious Disease Product (QIDP) status and Fast Track designation from the US FDA, reflecting its potential to address the escalating challenge of Gram-negative infections. Zaynich™ demonstrates promise in treating a wide range of infections caused by MDR and XDR pathogens, including Enterobacterales, Pseudomonas aeruginosa, and Acinetobacter baumannii, offering a potentially transformative solution for difficult-to-treat infections.