Wockhardt secures US FDA approval for ZAYNICH

Wockhardt has announced that the US Food and Drug Administration (FDA) has approved ZAYNICH (cefepime and zidebactam), an intravenous antibiotic for the treatment of adults 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.

Commenting on the approval, Dennis Deruelle, MD, FHM, Chief Medical Officer, Wockhardt, said, “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. 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.”

Dr Habil F. Khorakiwala, Founder and Chairman, Wockhardt Group, said, “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. 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.”

According to the company, ZAYNICH targets multiple penicillin binding proteins (PBP 1a/b, 2 and 3) simultaneously. The company stated that this mechanism provides bactericidal activity against drug-resistant Gram-negative bacteria for which treatment options are limited.

Keith Kaye, MD, MPH, Professor of Medicine and Division Chief for Infectious Diseases at Rutgers Robert Wood Johnson Medical School, said, “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. 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 hospitalisations annually in the United States. The company noted that a growing number of cUTIs are caused by antimicrobial-resistant bacteria, including multidrug-resistant bacteria, which are associated with bacteraemia, morbidity, mortality and healthcare system burden.

The FDA approval was based, in part, on results from ENHANCE-1, a Phase III randomised, double-blind, multicentre study evaluating the efficacy, safety and tolerability of ZAYNICH compared with meropenem in hospitalised adults with cUTI or acute pyelonephritis.

According to Wockhardt, ZAYNICH achieved the primary endpoint, recording a composite clinical cure and microbiological response rate of 89.0 per cent compared with 68.4 per cent for meropenem, with a treatment difference of 20.6 per cent (95 per cent CI; 12.3, 29.5). The company stated that ZAYNICH was generally well tolerated in the Phase III study.

The trial enrolled 530 patients across 64 sites in the United States, Europe, Latin America, China and India.

Wockhardt also stated that ZAYNICH® received approval from the Drugs Controller General of India (DCGI) on 27 May 2026. The company has additionally submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency.

ZAYNICH is an injectable antibiotic comprising 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).

According to the company, cefepime and zidebactam work together by binding multiple PBPs, leading to bacterial killing. The company added that this activity occurs in the presence of β-lactamases, including metallo-β-lactamases (MBLs), and other non-enzymatic cefepime resistance mechanisms such as hyper-efflux and downregulation of outer membrane porin channels.

The company stated that ZAYNICH was granted Priority Review, Fast Track and Qualified Infectious Disease Product designations for complicated urinary tract infections (cUTI), complicated intra-abdominal infections (cIAI), hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP).

Wockhardt added that ZAYNICH has been made available through expanded access programmes in multiple countries, including the United States, for patients with limited treatment options.