Mumbai-based pharmaceutical company Wockhardt has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (USFDA) for its novel antibiotic, Zaynich (WCK 5222), marking a significant milestone in Indian pharmaceutical innovation.
This submission, made in early October 2025, seeks approval for the treatment of complicated urinary tract infections (cUTIs) caused by multi-drug resistant (MDR) and extensively drug-resistant (XDR) gram-negative bacteria, including strains of Pseudomonas aeruginosa and Acinetobacter baumannii.
Zaynich is a combination of zidebactam, a β-lactam enhancer, and cefepime, a fourth-generation cephalosporin. It has demonstrated over 97% clinical efficacy in Phase III trials, surpassing the standard-of-care meropenem by 20%.
The ENHANCE 1 trial, conducted across 64 sites in countries including the United States, India, and several European nations, enrolled 530 patients with serious infections.
Zaynich achieved a 96.8% clinical cure rate and a composite clinical and microbiological cure rate of 89%, outperforming meropenem’s 68.4% in the same endpoint.
The drug has also shown promise in compassionate use cases, with reports indicating that it has saved at least 51 lives in the United States and India as of mid-2025. Some earlier reports suggest that 30-50 patients had been treated with a 100% success rate.
Following the NDA submission, the USFDA will conduct a 60-day filing review to assess the application’s completeness. If accepted, Zaynich may be granted either Priority Review, with a six-month timeline, or Standard Review, with a ten-month timeline. The process includes facility inspections, labeling negotiations, and potentially an advisory committee meeting. Zaynich has received Fast Track and Qualified Infectious Disease Product (QIDP) designations, which expedite the review process and offer five additional years of market exclusivity upon approval.
Wockhardt anticipates a decision by mid to late 2026 and is targeting a U.S. launch in fiscal year 2027. The global market for gram-negative infections is estimated to be over $7 billion, with more than 8 million cUTI cases reported annually in the U.S. and European Union. Zaynich’s potential to address this unmet medical need positions it as a promising candidate for approval.
This submission is notable as it represents the first-ever NDA submission to the USFDA for a drug fully discovered and developed by an Indian pharmaceutical company, marking a pivotal moment for Indian pharma innovation. Wockhardt plans to commercialize Zaynich independently in the U.S., though it has not ruled out potential partnerships.
The successful development and potential approval of Zaynich underscore the growing capabilities of Indian pharmaceutical companies in pioneering novel therapies to combat global health challenges.
If approved, Zaynich could significantly enhance Wockhardt’s global footprint and revenue, reinforcing India’s position in the global pharmaceutical landscape.
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