Date: 30th May, 2026
Product Launch Details
Wockhardt received U.S. FDA approval for ZAYNICH™ (cefepime and zidebactam), a novel intravenous antibiotic for the treatment of adult patients with complicated urinary tract infection including pyelonephritis. ZAYNICH™ is a multi-penicillin-binding protein targeting combination of the 4th generation cephalosporin cefepime and zidebactam working synergistically against the most challenging multidrug-resistant Gram-negative bacteria.
Clinical Trial Results
In the Phase 3 ENHANCE-1 clinical trial, ZAYNICH™ demonstrated higher combined clinical cure and microbiologic response (composite endpoint) at the test of cure (TOC) visit versus meropenem, achieving 89.0% success rate compared to 68.4% for meropenem (treatment difference 20.6%, 95% CI; 12.3, 29.5). The study enrolled 530 patients from the U.S., Europe, LATAM, China and India, spanning across 64 sites. ZAYNICH™ was generally well tolerated in the phase 3 study.
Regulatory Status and Designations
ZAYNICH™ previously received Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA. The drug was also approved by the Drugs Controller General of India (DCGI) on May 27, 2026. Wockhardt has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency.
Market Context and Significance
Complicated urinary tract infections cause over 600,000 hospitalizations in the U.S. annually, with growing antimicrobial resistance. More than 2.8 million antimicrobial-resistant infections occur each year in the U.S., resulting in more than 35,000 deaths. This approval represents the first New Chemical Entity fully developed and commercialized by an Indian pharmaceutical company to receive FDA approval.
Mechanism of Action
ZAYNICH™ comprises cefepime, a cephalosporin antibacterial drug and zidebactam, a non-β-lactam antibacterial and β-lactamase inhibitor. Cefepime primarily targets penicillin-binding protein-3 (PBP3) and PBP1a/b in Enterobacterales and PBP3 in other Gram-negative bacterial pathogens, while zidebactam selectively inhibits penicillin-binding protein-2 (PBP2). The components work synergistically by binding multiple PBPs, leading to bacterial killing even in the presence of β-lactamases.
Indications and Usage
ZAYNICH™ is indicated for the treatment of adult patients with complicated urinary tract infections (cUTI) including pyelonephritis caused by susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Enterobacter cloacae complex, and Pseudomonas aeruginosa.
Safety Information
The most common adverse reactions occurring in ≥2% of patients receiving ZAYNICH™ were diarrhea, hypertension, headache, and hypokalemia. The drug is contraindicated in patients with known history of serious hypersensitivity to components or other beta-lactam antibacterial drugs. Important warnings include hypersensitivity reactions, neurotoxicity, Clostridioides difficile-associated diarrhea, positive direct Coombs' tests, and prolonged prothrombin time.
Company Background
Wockhardt is a global pharmaceutical and biotechnology company focused on developing innovative anti-infective solutions with a pipeline of six antibiotics at various stages of clinical development and commercialization. The company employs around 3,200 people across 27 nationalities with presence in India, the UK, the U.S., Ireland, Switzerland, France, Mexico, Russia, and other countries.