FDA Approves Zaynich for Complicated Urinary Tract Infections
The FDA has approved Zaynich for the treatment of complicated urinary tract infections (cUTIs), including Pyelonephritis, in adults. In clinical trials, Zaynich demonstrated a higher treatment response rate than meropenem and was generally well tolerated. The approval addresses an important unmet need by expanding treatment options for infections caused by drug-resistant gram-negative bacteria, a growing global health challenge.
"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 beta-lactam and beta-lactamase inhibitor combinations targets multiple penicillin binding protein (PBP 1a/b, 2, 3) simultaneously in most clinically important Gram negatives expressing diverse resistance mechanisms. 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 life-threatening 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 U.S. 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.3
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, a 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.
