Wockhardt has secured US FDA approval for ZAYNICH (cefepime and zidebactam), a new intravenous antibiotic designed to treat adults with complicated urinary tract infections (cUTI), including pyelonephritis caused by susceptible Gram-negative pathogens.
The approval marks a major milestone in the global fight against antimicrobial resistance, a crisis responsible for more than 2.8 million infections and over 35,000 deaths annually in the United States alone.
ZAYNICH is a combination therapy pairing the fourth-generation cephalosporin cefepime with zidebactam, engineered to act synergistically against highly drug-resistant Gram-negative bacteria. The drug was previously granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by 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 ZAYNICHTM is a monumental step forward in validating a new option for these underserved populations,” said Dennis Deruelle, 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.”
Company leadership described the approval as both a medical and industrial breakthrough.
“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,” said Habil F. Khorakiwala, Founder and Chairman of Wockhardt Group.
“Furthermore, ZAYNICHTM 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.”
Unlike most beta-lactam combinations, ZAYNICH targets multiple penicillin-binding proteins simultaneously, including PBP1a/b, PBP2 and PBP3, enabling broad bactericidal activity against difficult-to-treat Gram-negative pathogens. The mechanism is designed to retain activity even against bacteria with advanced resistance features.
“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 life-threatening complications,” explained Keith Kaye, 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.”
Complicated urinary tract infections account for more than 600,000 hospitalizations in the U.S. each year, with rising rates driven by antimicrobial-resistant bacteria that can lead to severe complications, including bloodstream infections and increased mortality.
The FDA’s decision was supported by data from the ENHANCE-1 Phase 3 clinical trial, a randomized, double-blind, multicenter study involving 530 hospitalized adults across 64 sites in the U.S., Europe, Latin America, China, and India. The study compared ZAYNICH against meropenem in patients with cUTI or acute pyelonephritis.
ZAYNICH™ achieved 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), and was generally well tolerated.
ZAYNICH was approved by India’s Drugs Controller General (DCGI) on May 27, 2026, and Wockhardt has also submitted a Marketing Authorization Application to the European Medicines Agency.
The company says ZAYNICH has already been made available through expanded access programs in several countries, including the United States, for patients with limited treatment options.
