Wockhardt announced that the FDA has approved ZAYNICH (cefepime and zidebactam), a novel intravenous antibiotic for adult patients with complicated urinary tract infections (cUTI), including pyelonephritis, caused by susceptible Gram-negative pathogens. ZAYNICH had previously received Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA, reflecting the significant unmet need in this area.
“The threat of drug-resistant infections is an escalating crisis, leaving clinicians with fewer tools to treat patients facing these aggressive pathogens,” said Dennis Deruelle, MD, FHM, chief medical officer at Wockhardt. He called the FDA approval “a monumental step forward” in validating a new option for underserved patients and said the milestone underscores the company’s commitment to addressing critical unmet needs and providing hope to affected families.
Founder and chairman Dr. Habil F. Khorakiwala said the approval is a major realization of Wockhardt’s mission to deliver novel antibiotics targeting antimicrobial resistance, described as one of the most urgent global health threats. He noted that ZAYNICH is the first new chemical entity fully developed and commercialized by an Indian pharmaceutical company to receive FDA approval, calling it a historic milestone for both Wockhardt and the broader Indian pharmaceutical industry.
ZAYNICH differs from most beta‑lactam and beta‑lactamase inhibitor combinations by simultaneously targeting multiple penicillin-binding proteins (PBP 1a/b, 2, and 3) in many clinically important Gram-negative bacteria that express diverse resistance mechanisms. This multi-target synergy provides bactericidal activity against highly drug-resistant Gram-negative pathogens for which current treatment options are very limited.
“Multidrug-resistant bacterial infections are a substantial burden for patients and the healthcare system,” said Keith Kaye, MD, MPH, professor of medicine and division chief for infectious diseases at Rutgers Robert Wood Johnson Medical School. He noted that these infections often require longer, more intensive care and carry a higher risk of life‑threatening complications. Kaye said there is an ongoing need for new antibiotics to combat drug-resistant pathogens and welcomed the approval as providing an “exciting unique option” urgently needed in the U.S. and worldwide.
cUTI leads to more than 600,000 hospitalizations annually in the U.S., and an increasing share of these infections are caused by antimicrobial-resistant, including multidrug-resistant, organisms. These infections are a leading cause of bacteremia and are associated with significant morbidity, mortality, and health system burden.
FDA approval of ZAYNICH was supported in part by ENHANCE-1, a Phase 3 randomized, double‑blind, multicenter study comparing ZAYNICH with meropenem in hospitalized adults with cUTI or acute pyelonephritis. ZAYNICH met the primary endpoint, achieving a composite clinical cure and microbiological response rate of 89.0% versus 68.4% for meropenem, a treatment difference of 20.6% (95% CI 12.3, 29.5). The antibiotic was generally well tolerated in the trial, which enrolled 530 patients across 64 sites in the U.S., Europe, Latin America, China, and India.
ZAYNICH was approved by India’s Drugs Controller General (DCGI) on May 27, 2026. Wockhardt has also submitted a Marketing Authorization Application to the European Medicines Agency as it looks to bring the drug to additional markets.
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