Wockhardt Receives U.S. FDA Approval for Novel Antibiotic ZAYNICH™

Wockhardt Receives U.S. FDA Approval for Novel Antibiotic ZAYNICH™​

Wockhardt Limited announced that the U.S. Food and Drug Administration (FDA) has approved ZAYNICH™ (cefepime and zidebactam). This novel intravenous antibiotic is intended for the treatment of adults suffering from complicated urinary tract infections (cUTI), including pyelonephritis, caused by susceptible Gram-negative pathogens.

ZAYNICH™ is a multipenicillin-binding protein combination, pairing the fourth-generation cephalosporin cefepime with zidebactam. This combination is designed to work synergistically against the most challenging multidrug-resistant Gram-negative bacteria.

Clinical Efficacy and Trial Results​

The FDA approval was based, in part, on the robust results from the ENHANCE-1 study. This Phase 3, randomized, double-blind, multicenter trial evaluated the efficacy, safety, and tolerability of ZAYNICH™ compared with meropenem in hospitalized adults with cUTI or acute pyelonephritis (AP).

The study found that ZAYNICH™ demonstrated significantly higher combined clinical cure and microbiologic response (composite endpoint) at the test of cure (TOC) visit compared to meropenem.


The study enrolled 530 patients across 64 sites in the U.S., Europe, LATAM, China, and India.

Addressing Global Health Threats​

The company highlighted the severe global challenge posed by drug-resistant infections, noting that more than 2.8 million antimicrobial-resistant infections occur each year in the U.S., leading to over 35,000 deaths. Furthermore, complicated urinary tract infections (cUTI) alone account for over 600,000 hospitalizations in the U.S. annually.

Dr. Habil F. Khorakiwala, Founder and Chairman of Wockhardt Group, stated that the approval was a significant realization of the group's mission to address antimicrobial resistance. He added that ZAYNICH™ represents a historic milestone as it is the first New Chemical Entity fully developed and commercialized by an Indian pharmaceutical company to receive FDA approval.

Mechanism and Indications​

ZAYNICH™ is an injectable antibiotic comprising cefepime and zidebactam. The drug's effectiveness stems from its unique, multi-target synergy, as it targets multiple penicillin binding proteins (PBP 1a/b, 2 and 3) simultaneously. This capability provides bactericidal activity against difficult drug-resistant Gram-negative bacteria.

The indication for ZAYNICH™ is the treatment of adult patients with cUTI, including pyelonephritis, caused by susceptible microorganisms such as Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Enterobacter cloacae complex, and Pseudomonas aeruginosa.

The approval was supplemented by earlier recognitions, as ZAYNICH™ previously received Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA. Wockhardt also announced that the drug was approved by the Drugs Controller General of India (DCGI) on May 27, 2026, and the company has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency.

WOCKPHARMA Stock Price Movement​

On Friday, Wockhardt Limited shares surged, settling at ₹2031.4, following a robust 14.34% rally for the session. The equity's climb pushed it close to its year-high of ₹2097.4, supported by a heavy trading volume of 13.17 million shares.