Wockhardt has filed a Marketing Authorisation Application (MAA) with the European Medicines Agency (EMA) for its novel antibiotic WCK 5222 on January 5, 2026. The EMA evaluates new medicines for approval across the 27 European Union member states and three European Economic Area countries, covering a total of 30 markets.
WCK 5222 is a fixed-dose combination of Zidebactam and Cefepime, developed to treat serious Gram-negative infections caused by multi-drug resistant pathogens. The EMA has confirmed that the product is eligible for Accelerated Assessment, a regulatory pathway that shortens review timelines for medicines addressing unmet medical needs.
The New Drug Application for WCK 5222 is already under fast-track review by the United States Food and Drug Administration. Based on clinical and regulatory data submitted, Wockhardt expects the medicine to be considered for use in treating resistant infections across countries under the EMA’s jurisdiction. The priority status reflects the growing global need for effective treatment options against life-threatening drug-resistant infections.
Notably, WCK 5222 is the first new chemical entity discovered and developed in India to be submitted for pan-European marketing approval. Marketed under the brand name Zaynich®, the antibiotic recently completed a global Phase III clinical trial designed to support regulatory filings in international markets. Applications have also been submitted to Indian regulatory authorities.
More than 50 patients in India and the United States with highly resistant infections have received Zaynich® under compassionate use programs. The drug has also undergone multiple Phase I studies in the U.S. and a multi-indication clinical study in India focused on carbapenem-resistant infections.
Wockhardt has spent over 27 years building a focused antibiotic discovery program targeting drug-resistant pathogens. Its pipeline includes six antibiotics at different stages of development, all of which have received Qualified Infectious Disease Product designation from the US FDA. The company employs around 2,900 people across multiple countries, with manufacturing and research facilities in India, the UK, and Ireland, and derives a significant portion of its revenue from international markets.
