The novel intravenous antibiotic is indicated for the treatment of adults with complicated urinary tract infections (cUTI), including pyelonephritis.

The approval marks a major milestone for the Mumbai-based drug maker, coming just days after the antibiotic received marketing approval in India on 27 May 2026. According to the company, ZAYNICH is the first new chemical entity fully discovered, developed and commercialised by an Indian pharmaceutical company to secure U.S. FDA approval.

ZAYNICH combines cefepime, a fourth-generation cephalosporin antibiotic, with zidebactam, a novel beta-lactam enhancer. The therapy is designed to tackle multidrug-resistant Gram-negative bacteria, including strains that have become resistant to many currently available antibiotics.

The FDA approval was supported by data from the global Phase 3 ENHANCE-1 study involving 530 patients across 64 sites worldwide. In the trial, ZAYNICH achieved a combined clinical cure and microbiological response rate of 89% at the test-of-cure visit, compared with 68.4% for meropenem, a commonly used antibiotic.

The drug has also received Qualified Infectious Disease Product (QIDP), Fast Track and Priority Review designations from the U.S. regulator.

Wockhardt said more than 2.8 million antimicrobial-resistant infections occur annually in the United States, resulting in over 35,000 deaths, highlighting the need for new treatment options.

The company has also filed a marketing authorisation application for the product with the European Medicines Agency.

Wockhardt is a research-driven global pharmaceutical and biotechnology company focused on developing anti-infective therapies. The company currently has six antibiotics at various stages of development and commercialisation, all of which have received QIDP designation from the US FDA.

Wockhardt reported a consolidated net profit of Rs 164 crore in Q4 FY26, compared with a net loss of Rs 45 crore in the corresponding quarter last year. Revenue from operations increased 29.87% YoY to Rs 965 crore during the quarter.