Cefepime hydrochloride/Zidebactam

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 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 More than 2.8 million antimicrobial-resistant infections occur each year in the U.S., resulting in more than 35,000 deaths1 June 1, 2026 -- Wockhardt today 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 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. ZAYNICH™ (cefepime and zidebactam) is an injectable antibiotic comprising of 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). Cefepime and zidebactam synergistically work together by binding multiple PBPs, leading to bacterial killing. This synergy occurs even in the presence of β-lactamases, including metallo- β-lactamases (MBLs), which are not inhibited by zidebactam, and other non-enzymatic cefepime resistance mechanisms, such as hyper-efflux and downregulation of outer membrane porin channels. ZAYNICH was granted Priority Review, Fast Track and Qualified Infectious Disease Product designations for the Complicated Urinary Tract Infections (cUTI), Complicated Intra-Abdominal Infections (cIAI), Hospital-Acquired Bacterial Pneumonia (HABP)/Ventilator-Associated Bacterial Pneumonia (VABP). ZAYNICH has also been made available through expanded access programs in multiple countries including the U.S. for patients with limited treatment options. Wockhardt is a global pharmaceutical and biotechnology company focused on developing innovative anti-infective solutions. With a legacy of scientific excellence and a mission to combat antimicrobial resistance, Wockhardt pioneers next-generation therapies for a healthier world. This commitment has resulted in a pipeline of six antibiotics at various stages of clinical development and commercialization; three of them target infections caused by Gram-Negative pathogens and three those by Gram-Positives. All six antibiotics have been granted Qualified Infectious Disease Product (QIDP) designation by the US FDA. Wockhardt employs around 3,200 people and 27 nationalities, with presence in India, the UK, the U.S., Ireland, Switzerland, France, Mexico, Russia, and many other countries. It has manufacturing and research facilities in India & the UK, and a manufacturing facility in Ireland. Wockhardt has a significant presence in Europe and India, with 78% of its global revenues coming from international businesses. 1 Centers for Disease Control and Prevention. (2019). Antibiotic resistance threats in the United States, 2019. U.S. Department of Health and Human Services. Retrieved May 27, 2026, from https://www-cdc-gov.libproxy1.nus.edu.sg/antimicrobial-resistance/media/pdfs/2019-ar-threats-report-508.pdf 2 Centers for Disease Control and Prevention. (2025, January 31). About antimicrobial resistance. Retrieved May 27, 2026, from https://www-cdc-gov.libproxy1.nus.edu.sg/antimicrobial-resistance/about/index.html 3 Marantidis, J., & Sussman, R. D. (2023). Unmet needs in complicated urinary tract infections: Challenges, recommendations, and emerging treatment pathways. Infection and Drug Resistance, 16, 1391–1405. https://doi-org.libproxy1.nus.edu.sg/10.2147/IDR.S382617 Retrieved May 27, 2026, from https://pubmed-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/36937144/ The content above comes from the network. if any infringement, please contact us to modify.