Shares of Wockhardt soared as much as 19% to their day's high of Rs 2,420 on the BSE on Monday after the company announced that the U.S. Food and Drug Administration (FDA) has approved ZAYNICH (cefepime and zidebactam), a novel intravenous antibiotic for the treatment of adults with complicated urinary tract infections (UTI), including pyelonephritis, caused by susceptible Gram-negative pathogens.
According to the company, ZAYNICH combines the fourth-generation cephalosporin cefepime with zidebactam and is designed to target multiple penicillin-binding proteins simultaneously. The antibiotic had earlier received Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA.
The approval comes at a time when antimicrobial resistance remains a major healthcare challenge. Wockhardt cited data indicating that more than 2.8 million antimicrobial-resistant infections occur annually in the United States, resulting in over 35,000 deaths each year.
The company also noted that complicated urinary tract infections account for more than 6,00,000 hospitalisations annually in the U.S., with a growing proportion linked to antimicrobial-resistant and multidrug-resistant bacteria.
The FDA's decision was based in part on results from the Phase 3 ENHANCE-1 study, a randomised, double-blind, multicentre trial that evaluated the efficacy, safety and tolerability of ZAYNICH against meropenem in hospitalised adults with complicated urinary tract infections or acute pyelonephritis.
Also read: FDA approval puts Wockhardt’s Zaynich in $9 billion antibiotics market
In the study, ZAYNICH achieved a composite clinical cure and microbiological response rate of 89% at the test-of-cure visit, compared with 68.4% for meropenem. The treatment difference was 20.6% with a 95% confidence interval of 12.3 to 29.5. The company said the drug was generally well tolerated during the trial.
The ENHANCE-1 study enrolled 530 patients across 64 sites spanning the United States, Europe, Latin America, China and India.
Wockhardt stated that ZAYNICH targets penicillin-binding proteins PBP 1a/b, 2 and 3 simultaneously, a mechanism that it says provides bactericidal activity against multidrug-resistant Gram-negative bacteria for which treatment options remain limited.
The company also disclosed that ZAYNICH received approval from the Drugs Controller General of India (DCGI) on May 27, 2026. In addition, Wockhardt has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency for the antibiotic.
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