Wockhardt has taken a major step in global healthcare by filing a Marketing Authorisation Application (MAA) with the European Medicines Agency (EMA) for its new antibiotic WCK 5222 on 5 January 2026.
The EMA is responsible for evaluating new medicines across 27 European Union countries and three European Economic Area nations like Norway, Iceland and Liechtenstein, covering a total of 30 countries. Approval through this route allows medicines to be marketed across all these regions.
WCK 5222 is a fixed-dose combination of Zidebactam (1 g) and Cefepime (2 g), designed to treat severe infections caused by multi-drug resistant Gram-negative bacteria. Recognising the urgent unmet medical need, the EMA has granted the drug Accelerated Assessment, enabling a faster review process.
The antibiotic is also under fast-track review by the US Food and Drug Administration (US FDA), reflecting strong global demand for new solutions to fight antibiotic resistance.
Antibiotic resistance has emerged as a serious public health concern in India, with misuse and overuse of antibiotics reducing their effectiveness. The issue has even been highlighted at the national level, with Prime Minister Narendra Modi addressing the dangers of antibiotic resistance in his radio programme Mann Ki Baat, urging citizens to use antibiotics responsibly and only when prescribed.
Based on strong clinical and regulatory data, Wockhardt expects WCK 5222 to receive approval for treating resistant infections across all countries under the EMA’s jurisdiction. The priority review underscores the global urgency to make effective treatments available for patients suffering from life-threatening drug-resistant infections.
Notably, WCK 5222 is the first New Chemical Entity (NCE) discovered and developed in India to be submitted for pan-European marketing approval, marking a historic milestone for Indian pharmaceutical innovation.
Zaynich® is a novel antibiotic developed by Wockhardt, combining Zidebactam and Cefepime to combat highly resistant Gram-negative infections. The drug has successfully completed a global Phase III clinical trial, supporting its approval in international markets.
Its New Drug Application (NDA) has been filed and accepted by the US FDA, and a marketing application has also been submitted to Indian regulatory authorities. Earlier Phase I studies were conducted in the United States, followed by multi-indication clinical trials in India focusing on carbapenem-resistant infections.
So far, more than 50 patients in India and the US with severe resistant infections have been treated with Zaynich® under compassionate use programmes.
For over 27 years, Wockhardt has focused on developing new antibiotics to address multi-drug resistant infections. Its pipeline includes six novel antibiotics at different stages of development, all of which have received Qualified Infectious Disease Product (QIDP) status from the US FDA.
Out of these, three antibiotics are already approved for clinical use, while two more are in the final stages of development, strengthening India’s role in the global fight against antibiotic resistance.
