Cefepime–Zidebactam (brand name ZAYNICH) developed by Wockhardt is a relatively new antibiotic combination .
In India
It’s approved by the Central Drugs Standard Control Organisation (CDSCO) / DCGI on 27 May 2026, * for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, and cases with concurrent Gram-negative bacteremia in adults.
It is Approved by the U.S. Food and Drug Administration (FDA) on 30 May 2026 under the brand name ZAYNICH®, for adults with complicated urinary tract infections caused by susceptible Gram-negative organisms.
The unique thing about its approval is-
- It is the first new chemical entity (NCE) antibiotic fully discovered and developed by an Indian pharmaceutical company to receive FDA approval.
- It introduces a first-in-class dual PBP-targeting mechanism (PBP2 and PBP3), offering activity against many multidrug-resistant and extensively drug-resistant Gram-negative pathogens.
Mechanism of action: - Cefepime: A fourth-generation cephalosporin antibiotic that Binds primarily to PBP3 (Penicillin- binding protein) inhibits bacterial cell wall synthesis.
- Zidebactam: A β-lactam enhancer with intrinsic antibacterial activity that binds strongly to Penicillin-Binding Protein 2 (PBP2).
Antimicrobial Spectrum of the drug
Active against many resistant Gram-negative pathogens, including:
• Escherichia coli
• Klebsiella pneumoniae
• Pseudomonas aeruginosa
• Acinetobacter baumannii
• Enterobacter species
Clinical uses include-
- Hospital-acquired pneumonia (HAP)
- Ventilator-associated pneumonia (VAP)
- Complicated urinary tract infections (cUTI)
- Complicated intra-abdominal infections
- Bloodstream infections caused by susceptible MDR Gram-negative bacteria
MBH/DB