Wockhardt has received a favourable recommendation from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization for the marketing approval of its novel antibiotic Zaynich® (Zidebactam/Cefepime), marking a major milestone in the fight against drug-resistant infections. The recommendation clears the path for final approval from the Drugs Controller General of India and represents a significant advancement in addressing the growing global challenge of multi-drug resistant Gram-negative infections. The SEC’s decision follows an extensive evaluation of clinical and non-clinical data, including nine Phase 1 studies, a multi-indication Phase 2 trial in meropenem-resistant infections, and a global Phase 3 study focused on complicated urinary tract infections and acute pyelonephritis.
Zaynich® has been developed over 15 years by a multidisciplinary team of more than 150 scientists. The antibiotic features a novel β-lactam enhancer-based mechanism designed to target highly resistant Gram-negative pathogens, including those classified as MDR and XDR, which are increasingly prevalent in India and globally.
Clinical data highlights the potential of the therapy. In a global Phase 3 study involving over 500 patients across multiple regions, the drug demonstrated superior clinical and microbiological outcomes compared to meropenem. Earlier studies in India showed clinical efficacy exceeding 97 percent in treating resistant infections, including hospital-acquired pneumonia, bloodstream infections, and complicated intra-abdominal infections.
The antibiotic has also shown promising results in 85 compassionate-use cases across India, the United States, Malaysia, and France, where treatment options were limited or unavailable. These findings underscore the urgent unmet need for effective therapies against resistant infections and position Zaynich® as a potential breakthrough treatment.
The Clinical and Laboratory Standards Institute has assigned an investigational susceptible breakpoint for the drug, indicating its potential to address critical pathogens in severely ill patients. Regulatory submissions for the product are already underway in the United States and European Union, with applications currently under review.
Wockhardt has focused on antimicrobial research for over two decades, building a robust pipeline of therapies targeting resistant infections. Several of its products have received Qualified Infectious Disease Product status from the US Food and Drug Administration, reflecting their importance in addressing public health challenges.
Wockhardt has spent over 27 years building a focused antibiotic discovery program targeting drug-resistant pathogens. Its pipeline includes six antibiotics at different stages of development, all of which have received Qualified Infectious Disease Product designation from the US FDA. The company employs around 2,900 people across multiple countries, with manufacturing and research facilities in India, the UK, and Ireland, and derives a significant portion of its revenue from international markets.
