Cefepime/Zidebactam: First Approval.

Cefepime/zidebactam (Zaynich®), a fixed-dose combination of the fourth-generation cephalosporin cefepime and the β-lactam enhancer zidebactam, that is being developed by Wockhardt for the treatment of serious infections caused by multidrug-resistant Gram-negative bacteria. With synergistic properties between the two drug components, cefepime/zidebactam has demonstrated in vitro bactericidal activity even in organisms with complex resistance mechanisms. Supported by the findings of the pivotal, active-controlled, phase III ENHANCE 1 trial, on 27 May 2026, cefepime/zidebactam received its first approval, in India, for the treatment of adult patients with complicated urinary tract infections (cUTI), including pyelonephritis, as well as cases with concurrent Gram-negative bacteraemia. Subsequently, on 29 May 2026, cefepime/zidebactam was approved in the USA for the treatment of adult patients with cUTI including pyelonephritis caused by designated susceptible microorganisms. Cefepime/zidebactam is also currently under regulatory review in the EU for use in the treatment of serious infections caused by Gram-negative bacteria. This article summarises the milestones in the development of cefepime/zidebactam leading to this first approval for the treatment of cUTI (including pyelonephritis) in adults.