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The FDA on May 29, 2026 approved Zaynich (cefepime and zidebactam), Wockhardt's intravenous antibiotic, for adults with complicated urinary tract infections including pyelonephritis caused by designated susceptible organisms.
Zaynich pairs cefepime, a cephalosporin, with zidebactam, which the label classifies as both a beta-lactamase inhibitor and a non-beta-lactam antibacterial in its own right. The label states that zidebactam lowers the proportion of time cefepime must stay above the minimum inhibitory concentration to work, which is how the pair reaches organisms cefepime alone would not.
Trial 1, which Wockhardt calls ENHANCE-1, randomized 530 adults 2:1 against meropenem for seven to ten days, with no switch to oral therapy permitted. Combined clinical cure and microbiological response at test of cure reached 89.0% on Zaynich against 68.4% on meropenem, a difference of 20.6 points. Among isolates screening positive for extended-spectrum beta-lactamases the split was 89% against 70%.
The label carries warnings for hypersensitivity, neurotoxicity and Clostridioides difficile infection.
Wockhardt says zidebactam came out of its own laboratories, and the trade press reports it as the first new chemical entity both discovered and commercialized by an Indian company to reach US approval. The label covers one indication, and the meropenem comparison stands in the labeled population.
Sources: FDA prescribing information; Drugs@FDA, NDA 220787; Wockhardt press release; ENHANCE-1 (NCT04979806); Urology Times
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