Wockhardt 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 (cUTI), including pyelonephritis, caused by susceptible Gram-negative pathogens. ZAYNICH™ previously received Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA.

“The threat of drug-resistant infections is an escalating crisis, leaving clinicians with fewer tools to treat patients facing these aggressive pathogens. The FDA approval of ZAYNICH™ is a monumental step forward in validating a new option for these underserved populations,” said Dennis Deruelle, MD, FHM, Chief Medical Officer at Wockhardt. “This milestone underscores our commitment to addressing critical unmet needs and offers a profound sense of hope to the families we are working to serve.”

“This approval is a significant realization of our mission to provide patients with novel antibiotics that help to address one of the most urgent global health threats—antimicrobial resistance,” 2 said Dr. Habil F. Khorakiwala, Founder and Chairman of Wockhardt Group. “Furthermore, ZAYNICH™ is the first New Chemical Entity fully developed and commercialized by an Indian pharmaceutical company to receive an FDA approval, representing a historic milestone not only for Wockhardt, but for the Indian pharmaceutical industry.”

ZAYNICH™, unlike most other beta-lactam combinations, targets multiple penicillin binding proteins (PBP 1a/b, 2 and 3) simultaneously. This unique, multi-target synergy provides bactericidal activity against the most challenging drug-resistant Gram-negative bacteria for which there are currently very limited treatment options.

“Multidrug-resistant bacterial infections are a substantial burden for patients and the healthcare system, as patients with these infections typically require longer, more intensive care, and are at increased risk of lifethreatening complications,” explained Keith Kaye, MD, MPH, Professor of Medicine and Division Chief for Infectious Diseases at Rutgers Robert Wood Johnson Medical School. “There is an ongoing need for new antibiotics to combat these drug-resistant pathogens, and we are pleased that this approval means patients will soon have an exciting unique option that is urgently needed in the US and worldwide.”

cUTI is responsible for over 600,000 hospitalizations in the U.S. annually. A growing number of cUTIs are caused by antimicrobial resistant bacteria, including multidrug-resistant bacteria, a leading cause of bacteremia and associated with significant morbidity and mortality and a burden on the health care system.

The FDA approval was based, in part, on the results from ENHANCE-1, a Phase 3, randomized, double-blind, multicenter study which evaluated the efficacy, safety and tolerability of ZAYNICH™ compared with meropenem in the treatment of hospitalized adults with cUTI or acute pyelonephritis (AP). ZAYNICH™ demonstrated efficacy at the primary endpoint, achieving a composite clinical cure and microbiological response rate of 89.0% versus 68.4% for meropenem Treatment difference 20.6% (95% CI; 12.3, 29.5). ZAYNICH™ was generally well tolerated in the phase 3 study. The study enrolled 530 patients from the U.S., Europe, LATAM, China and India, and spanned across 64 sites.

ZAYNICH® was approved by the Drugs Controller General of India (DCGI) on May 27, 2026. Wockhardt has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency.

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 Gramnegative bacteria.

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, 89.0% vs 68.4% respectively and was generally well tolerated.

Source: Wockhardt Press Release

More than 2.8 million antimicrobial-resistant infections occur each year in the U.S., resulting in more than 35,000 deaths.