Wockhardt Ltd today announced that the Central Drugs Standard Control Organisation (CDSCO) has granted marketing authorization for ZAYNICH® (Zidebactam/Cefepime), the company’s indigenously discovered and developed breakthrough antibiotic for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, in adult patients with concurrent Gram-negative bacteremia. The approval marks a major milestone in India’s fight against antimicrobial resistance and strengthens the country’s position in advanced anti-infective drug innovation.
ZAYNICH® received approval based on findings from the global Phase 3 ENHANCE-1 clinical study (NCT04979806), a multinational, randomized, double-blind trial comparing the efficacy and safety of ZAYNICH® against meropenem in patients suffering from cUTI, including pyelonephritis. In the study, patients were randomized in a 2:1 ratio to receive either ZAYNICH® or meropenem.
The trial demonstrated statistically superior outcomes for ZAYNICH® on the primary composite endpoint of clinical cure and microbiological eradication at the test-of-cure visit. The endpoint was achieved in 89% of patients treated with ZAYNICH®, compared with 68.4% in the meropenem treatment arm, reflecting a treatment difference of 20.6% in favor of ZAYNICH®. Importantly, among patients presenting with concomitant bacteremia at baseline, ZAYNICH® recorded a composite response rate of 89%, compared with 44% for meropenem, highlighting its potential effectiveness in severe and difficult-to-treat infections.
Prior to the Phase 3 program, the antibiotic was evaluated across nine Phase 1 studies and a Phase 2 trial involving patients with documented meropenem-resistant Gram-negative infections. Conducted at 15 leading tertiary care hospitals across India, the Phase 2 study demonstrated clinical efficacy exceeding 97% across serious infections including hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), bloodstream infections (BSI), complicated intra-abdominal infections (cIAI), and cUTI.
ZAYNICH® has also shown promise against metallo-β-lactamase (MBL)-mediated resistance, one of the most challenging resistance mechanisms encountered in India. The Clinical and Laboratory Standards Institute has assigned Cefepime/Zidebactam an investigational susceptible breakpoint of 64 mg/L, supporting its potential utility against extensively drug-resistant Gram-negative pathogens.
Wockhardt is a research-driven global pharmaceutical and biotechnology company focused on innovative anti-infective therapies. The company currently has six antibiotics in various stages of development and commercialization, all of which have received Qualified Infectious Disease Product (QIDP) designation from the US FDA.
