Mumbai, January 7, 2026: Wockhardt Limited (BSE: 532300, NSE: WOCKPHARMA) on Wednesday announced that it has successfully filed a Marketing Authorisation Application (MAA) for its novel antibiotic WCK 5222 with the European Medicines Agency, marking a significant milestone in the company’s global drug development journey.
The application was filed on January 5, 2026, and seeks approval for WCK 5222 across European Union member states and associated markets under the centralised review mechanism. The filing follows the completion of an extensive clinical development programme and submission of comprehensive clinical and regulatory data.
Accelerated Review Path and Global Progress
WCK 5222 has already been found eligible for an accelerated assessment pathway in Europe, enabling a shortened review timeline in view of the unmet medical need addressed by the therapy. The drug’s regulatory review is also progressing in other major markets, with its new drug application currently under fast-track review in the United States.The company stated that the priority review status reflects the growing global urgency to address life-threatening, multi-drug resistant Gram-negative infections, an area where treatment options remain limited.
First India-Discovered NCE Filed for Pan-European Approval
Notably, WCK 5222 is the first new chemical entity discovered and developed in India to be submitted for pan-European marketing authorisation. The development underscores Wockhardt’s long-standing focus on antibiotic innovation and its ability to advance complex molecules through late-stage global regulatory pathways.Based on the data submitted, the company expects the drug to be approved for the treatment of resistant Gram-negative infections across European markets under the agency’s jurisdiction.
About Zaynich (Zidebactam/Cefepime, WCK 5222)
Marketed under the brand name Zaynich, WCK 5222 is a fixed-dose combination of Zidebactam and Cefepime designed to combat severe, multi-drug resistant Gram-negative bacterial infections. The drug has successfully completed a global pivotal Phase III clinical trial, which forms the basis for its marketing applications in multiple regions.Prior to the Phase III programme, the combination underwent multiple Phase I clinical pharmacology studies in the United States and a multi-indication clinical study in India focused on carbapenem-resistant infections. More than 50 patients in India and the US with highly resistant infections have been treated with the drug under compassionate use programmes.
Strong Antibiotic Discovery Pipeline
Wockhardt has been engaged in antibiotic research for over 27 years and currently maintains a pipeline of six antibiotics at various stages of clinical development and commercialisation. All of these candidates have received special infectious disease designations in the United States, with three already approved for clinical use and two nearing final-stage development.About the Company
Wockhardt Limited is a global pharmaceutical and biotechnology company with a strong presence in Europe and India. The company operates manufacturing and research facilities in India, the UK, and Ireland, and has operations across multiple international markets. Around three-fourths of its global revenues are derived from overseas businesses, reflecting its export-led pharmaceutical portfolio and focus on regulated markets.Source:
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