Wockhardt’s novel antibiotic Zaynich has received marketing approval from the Central Drugs Standard Control Organization (CDSCO) for use in adult patients with complicated urinary tract infections (cUTI), including kidney infections such as pyelonephritis, marking a key milestone for India’s antibiotic innovation pipeline. The authorisation covers the treatment of adults aged 18 years and above. Also, it extends to cases where these infections are accompanied by Gram‑negative bacteremia, a serious bloodstream infection caused by bacteria.
Zaynich, Wockhardt’s most advanced antibacterial candidate, is a fixed‑dose combination of cefepime and zidebactam, engineered to address infections caused by drug‑resistant Gram‑negative bacteria. The two agents work together by disrupting bacterial cell‑wall formation and binding to penicillin‑binding protein 2 (PBP2), a key protein essential for bacterial survival, a mechanism designed to retain activity against multi‑drug resistant (MDR) and extensively drug‑resistant (XDR) pathogens.
The CDSCO approval for import and marketing in India is backed by data from ENHANCE‑1, a pivotal global Phase 3, randomised, double‑blind trial that evaluated Zaynich against meropenem in patients with cUTI, including pyelonephritis. In this study, Zaynich outperformed standard therapy with meropenem on key efficacy endpoints for curing complicated urinary tract infections, supporting its use as a potential new option where resistance to existing agents is a growing concern.
Zaynich’s Indian approval follows an earlier positive recommendation from the Subject Expert Committee (SEC) of CDSCO, which had reviewed a comprehensive package including nine Phase 1 studies, a multi‑indication Phase 2 trial in meropenem‑resistant infections, the ENHANCE‑1 Phase 3 study and data from 85 compassionate‑use cases. In real‑world meropenem‑resistant infections across leading tertiary care hospitals in India, the antibiotic has previously demonstrated clinical efficacy of over 97 per cent, further bolstering its clinical profile in difficult‑to‑treat Gram‑negative infections.
Regulators and experts have also highlighted Zaynich’s breadth of activity, with the Clinical and Laboratory Standards Institute (CLSI) assigning the cefepime/zidebactam combination an investigational susceptible breakpoint of 64 mg/L, a parameter that supports its potential to comprehensively cover clinically important XDR Gram‑negative pathogens in critically ill patients. For Wockhardt, which has invested heavily in novel antibiotic discovery, the marketing approval in India is expected to serve as a springboard for planned submissions in key global markets, with the company already signalling its intention to file in the US and Europe based on the same pivotal data package.
