Wockhardt applies to seek USFDA nod for ‘miracle’ antibiotic Zaynich

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26 Aug, 2025 12:21

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Drugmaker Wockhardt has filed a New Drug Application (NDA) with the USFDA for its novel antibiotic Zaynich early this week.

The drug targets complicated urinary tract infections (cUTIs) caused by multi-drug resistant (MDR) gram-negative bacteria. The Mumbai-based company is eyeing a US launch in FY27, marking a pivotal moment for Indian pharma innovation.

About Zaynich

Zaynich is a combination of Zidebactam, a β-lactam enhancer, and Cefepime, a fourth-generation cephalosporin. It is designed to tackle MDR and extensively drug-resistance (XDR) pathogens including Pseudomonas Aeruginosa, Acinetobacter Baumannii, and Carbapenem-resistant strains.

During the Phase III trials, Zaynich showed a 96.8% cure rate in cUTI and 89% overall efficacy, outperforming standard-of-care Meropenem by 20%. Compassionate use of Zaynich has saved at least 51 lives in the United States and India as of mid-2025, with some reports from 2024 and earlier claiming that 30-50 patients had been treated with a 100% success rate.

What Next After NDA: US Approval Timeline

Following the NDA submission in October 2025, Wockhardt’s Zaynich will undergo the USFDA’s structured review process. The agency first conducts a 60-day filing review to determine if the application is complete. Once accepted, the drug may be granted either Priority Review (6-month timeline) or Standard Review (10-month timeline), culminating in a decision by the Prescription Drug User Fee Act (PDUFA). The process includes facility inspections, labeling negotiations, and potentially an advisory committee meeting, especially for novel therapies.

Zaynich has received Fast Track and Qualified Infectious Disease Product (QIDP) designations, which not only expedite the review process but also offer five additional years of market exclusivity upon approval.

Wockhardt expects a decision by mid to late 2026 and is targeting a US launch in FY27. If successful, this would mark a major milestone for Indian pharma, positioning Wockhardt as a global innovator in the fight against anti-microbial drug resistance.

Multi-billion Dollar Potential

Wockhardt is targetting a global market worth over $7 billion for Gram-negative infections. With over 8 million cUTI cases annually in the US and EU, Zaynich has the potential to become a blockbuster drug, if and when approved. Wockhardt is prioritising commercialisation of the drug on its own in the US, though it has not fully closed the doors for partnerships.

The drug’s success could significantly boost Wockhardt’s global footprint and revenue, given its strong presence in Europe and international markets.

Wockhardt stock on the BSE has delivered a strong performance and significantly outperformed the Sensex over the past year, rising approximately 54%.

Antibiotic Research - An Ignored Area

Khorakiwala, more than two decades ago had spotted that the big pharmaceutical companies have largely stepped away from antibiotic research due to an unfavourable economic model as antibiotics are typically low-priced, used for short durations, and face high development costs, making them less profitable than drugs for chronic conditions like cancer, hypertension, diabetes and weight loss.

Between 2003 and 2023, there were multiple years with no new antibiotic approvals, underscoring a slowdown.
However, the rise of super bugs resistant against existing antibiotics has become a cause of concern.

Recent incentives like the Generating Antibiotic Incentives Now (GAIN) Act in US have helped revive interest on antibiotic research. The GAIN Act aimed incentivizes the development of new antibacterial and antifungal drugs through "Qualified Infectious Disease Products" (QIDPs) benefits including fast-track designation, priority review by the USFDA, and a 5-year extension of market exclusivity beyond patent protection. This additional exclusivity helps pharmaceutical companies recoup costs and encourages investment in a field with declining research and development.

Why It Matters for Indian Pharma

Zaynich is the first Indian-discovered antibiotic to reach NDA stage with the USFDA, a milestone that shifts India’s pharma narrative from generics to innovative drug discovery, potentially opening doors for more R&D-driven exports and global partnerships.