Wockhardt announced that its novel antibiotic Zaynich® (Zidebactam/Cefepime) has received a favourable recommendation from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) for the treatment of Gram-negative infections. This recommendation moves the drug closer to final approval from the Drugs Controller General of India (DCGI).

The positive opinion comes after an extensive evaluation of clinical and non-clinical data, including multiple Phase 1 studies, a Phase 2 trial in drug-resistant infections, and a large global Phase 3 study focused on complicated urinary tract infections and acute pyelonephritis.

Zaynich® has been developed over 15 years by a multidisciplinary team and features a novel á-lactam enhancer-based mechanism, designed to combat multi-drug resistant (MDR) and extensively drug-resistant (XDR) Gram-negative pathogens—an area of significant unmet medical need, especially in India.

Clinical trials demonstrated strong results, with the drug outperforming meropenem in Phase 3 studies in terms of both clinical and microbiological cure rates. It also showed over 97% efficacy in real-world studies involving resistant infections across leading hospitals in India.

Additionally, the antibiotic has shown promising outcomes in compassionate-use cases globally, including in India, the US, Malaysia, and France, where treatment options were limited.

Regulatory filings for Zaynich® are already underway in global markets, with applications submitted in both the United States and the European Union, currently under advanced stages of review.