Wockhardt Limited has informed the Exchange regarding a press release dated May 29, 2026, titled " Wockhardt Receives U.S. FDA Approval for ZAYNICH (cefepime and zidebactam), a Novel Intravenous Antibiotic for the Treatment of Adult Patients with Complicated Urinary Tract Infection Including Pyelonephritis.
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Wockhardt has received U.S. FDA approval for ZAYNICH, a novel intravenous antibiotic combining cefepime and zidebactam for treating adults with complicated urinary tract infections including pyelonephritis. In the Phase 3 ENHANCE-1 trial involving 530 patients, ZAYNICH demonstrated superior efficacy with 89.0% composite clinical cure and microbiological response versus 68.4% for meropenem. The drug works by targeting multiple penicillin-binding proteins, offering a new option against drug-resistant bacteria. Notably, ZAYNICH is the first New Chemical Entity fully developed and commercialized by an Indian pharmaceutical company to receive FDA approval. The drug was also approved by India's DCGI on May 27, 2026, and a Marketing Authorization Application has been submitted to the European Medicines Agency.
This FDA approval represents a significant positive development for Wockhardt, opening access to the large U.S. antibiotics market and validating the company's research capabilities. As the first Indian NCE to achieve this milestone, it positions Wockhardt as a leader in novel anti-infective development and could drive meaningful future revenue growth.