Wockhardt has received marketing authorization from India’s drug regulator, the Central Drugs Standard Control Organisation (CDSCO), for its breakthrough antibiotic ZAYNICH® (Zidebactam/Cefepime). The approval marks a significant milestone for India’s fight against antimicrobial resistance, especially in difficult-to-treat Gram-negative bacterial infections.
The newly approved drug will be used for the treatment of adult patients suffering from complicated urinary tract infections (cUTI), including pyelonephritis, as well as cases associated with concurrent Gram-negative bacteremia.
According to the company, the approval is based on results from the pivotal ENHANCE-1 Phase 3 clinical trial, a multinational, randomized, double-blind study comparing ZAYNICH® with meropenem, one of the widely used last-resort antibiotics for severe infections.
The study demonstrated strong superiority of ZAYNICH® over meropenem in achieving both clinical cure and microbiological eradication at the test-of-cure visit. The primary endpoint was achieved in 89% of patients treated with ZAYNICH®, compared to 68.4% in the meropenem group, showing a treatment difference of over 20% in favor of the new antibiotic.
Notably, among patients who had bloodstream infections caused by Gram-negative bacteria at baseline, response rates were significantly higher with ZAYNICH®. Around 89% of such patients responded successfully in the ZAYNICH® arm compared to 44% in the meropenem arm, highlighting its potential role in managing severe and high-risk infections.
Before entering the Phase 3 program, the antibiotic had already undergone extensive clinical evaluation through nine Phase 1 studies and a Phase 2 study conducted across 15 tertiary care hospitals in India. The Phase 2 trial reported more than 97% clinical efficacy in serious infections including hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), bloodstream infections, complicated intra-abdominal infections, and complicated urinary tract infections.
Experts believe the approval is particularly important because India faces a growing burden of carbapenem-resistant and extensively drug-resistant (XDR) Gram-negative infections. Existing treatment options such as colistin and polymyxins are often associated with serious toxicity and limited effectiveness.
Wockhardt stated that ZAYNICH® has shown the ability to target metallo-β-lactamase (MBL)-mediated resistance mechanisms, which are among the most challenging and prevalent causes of antibiotic resistance in India.
The antibiotic combines Cefepime, a cephalosporin antibacterial drug, with Zidebactam, a novel β-lactam enhancer antibiotic. Both components work together by targeting multiple penicillin-binding proteins in Gram-negative bacteria, resulting in effective bacterial killing.
The company also revealed that under compassionate use programs, ZAYNICH® has already demonstrated encouraging clinical outcomes in 85 cases of extensively drug-resistant Gram-negative infections across India, the United States, Malaysia, and France, particularly where no effective treatment alternatives were available.
Meanwhile, Wockhardt has submitted a New Drug Application (NDA) in the United States and a Marketing Authorisation Application (MAA) in the European Union for Cefepime/Zidebactam, both of which are currently under regulatory review.
The antibiotic has additionally received Priority Review, Fast Track, and Qualified Infectious Disease Product (QIDP) designations from the US FDA for multiple serious infections, including complicated urinary tract infections, complicated intra-abdominal infections, and hospital-acquired bacterial pneumonia.
The approval of ZAYNICH® is being viewed as a major achievement for India’s pharmaceutical innovation ecosystem and a potentially important step in addressing the global antimicrobial resistance crisis.
