Wockhardt Ltd., a research-based global pharmaceutical and biotechnology company, announced that the Central Drugs Standard Control Organisation (CDSCO) has granted marketing authorization for the import and marketing of its indigenously discovered and developed, first-in-class breakthrough antibiotic, ZAYNICH® in India.
The approval is designated for the treatment of adult patients (aged 18 and above) suffering from complicated urinary tract infections (cUTI), including pyelonephritis (severe kidney infection), as well as high-risk cases presenting with concurrent Gram-negative bacteremia (bloodstream infections).
The CDSCO regulatory nod is backed by robust data from Wockhardt’s pivotal ENHANCE-1 study, a multinational, randomized, double-blind Phase 3 clinical trial evaluating the efficacy and safety of ZAYNICH® compared to the gold-standard treatment, meropenem. Adult patients with complicated urinary tract infections, ZAYNICH® achieved a remarkable 89.0% composite cure rate combining both clinical and microbiological success compared to just 68.4% for meropenem. This represents a substantial 20.6% therapeutic advantage in favor of Wockhardt’s new antibiotic. Furthermore, looking at clinical recovery alone, ZAYNICH® achieved a 96.8% cure rate, which stands as the highest performance recorded in its drug class over the last decade. These robust outcomes were evaluated during a Test-of-Cure assessment roughly 10 days after therapy, with the drug showing exceptionally strong results in high-risk patients suffering from concurrent bloodstream infections.Traditionalreserve treatments like polymyxins and colistin carry significant toxicity risks (such as severe kidney damage). ZAYNICH® provides clinicians with a highly effective, safer therapeutic alternative capable of neutralizing complex resistance pathways, including Metallo-beta-Lactamase (MBL)-producing and extensively drug-resistant (XDR) strains.
Antimicrobial Resistance (AMR) is one of the most critical unmet medical needs globally, with India bearing a disproportionately high burden of meropenem-resistant pathogens. ZAYNICH® utilizes a unique, novel \beta-lactam enhancer mechanism of action that targets multiple Penicillin-Binding Proteins (PBPs).
In recognition of its broad-spectrum capability, the Clinical and Laboratory Standards Institute (CLSI) has assigned Cefepime/Zidebactam an unprecedented investigational susceptible breakpoint of 64 mg/L. This ensures comprehensive coverage against highly resistant, critically ill pathogen variants.
Written by: Pragna Biswas
