The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has granted a favourable recommendation for marketing permission of Wockhardt’s novel antibiotic, Zaynich® (Zidebactam/Cefepime) for the treatment of Gram-negative infections. This recommendation marks a major regulatory milestone and paves the way for final approval from the Drugs Controller General of India (DCGI).
The positive opinion comes after an extensive evaluation of the drug’s clinical, non-clinical, and real-world data, highlighting its potential to address the growing challenge of multi-drug resistant (MDR) and extensively drug-resistant (XDR) Gram-negative infections.
Comprehensive Clinical Evaluation Supports Approval
The SEC’s recommendation follows a detailed review of the complete product dossier, which includes robust evidence from multiple clinical studies. The evaluation covered non-clinical research, nine Phase 1 clinical trials, a multi-indication Phase 2 study in meropenem-resistant infections, and a global Phase 3 study in complicated urinary tract infections and acute pyelonephritis (cUTI/AP).
In addition, the committee reviewed data from 85 compassionate-use cases, where the antibiotic was administered to critically ill patients who had limited or no effective treatment alternatives.
Fifteen Years of Research Behind Zaynich®
Wockhardt developed Zaynich® over a period of 15 years through the collaborative efforts of more than 150 scientists across 10 scientific disciplines. The antibiotic features a novel β-lactam enhancer–based mechanism, which significantly enhances the activity of cefepime against highly resistant bacteria.
Because of this innovative mechanism, Zaynich® offers potentially unprecedented coverage against MDR and XDR Gram-negative pathogens, which are increasingly prevalent in India and across the world.
Furthermore, the antibiotic has undergone one of the most comprehensive clinical evaluation programs among recently developed antibiotics, supported by over 100 national and international scientific publications and presentations, most of which were conducted by independent researchers and experts.
Global Clinical Trials Strengthen Evidence
The clinical development programme for Zidebactam/Cefepime includes nine Phase 1 studies conducted in the United States and China, involving nearly 300 healthy subjects.
Subsequently, researchers conducted a large global Phase 3 trial involving 530 patients across 64 clinical sites in the United States, Europe, Latin America, China, and India. In parallel, a Phase 2 study evaluated the drug in patients with meropenem-resistant infections, further demonstrating its therapeutic potential.
Superior Outcomes in Phase 3 Study
In the Phase 3 trial, Zidebactam/Cefepime demonstrated superiority over meropenem, a widely used antibiotic, in achieving combined clinical and microbiological cure among patients with complicated urinary tract infections and acute pyelonephritis.
These results highlight the clinical impact of its novel mechanism of action and its potential to become a powerful treatment option for severe Gram-negative infections.
Strong Real-World Effectiveness in Resistant Infections
Earlier real-world research also produced encouraging results. In a multicentre study conducted across 15 leading tertiary care hospitals in India, the antibiotic achieved over 97% clinical efficacy in patients with meropenem-resistant infections.
The study included patients suffering from serious and life-threatening conditions such as:
- Hospital-acquired bacterial pneumonia (HABP)
- Ventilator-associated bacterial pneumonia (VABP)
- Bloodstream infections (BSI)
- Complicated intra-abdominal infections (cIAI)
- Complicated urinary tract infections (cUTI)
These findings further reinforce the drug’s potential role in managing difficult-to-treat infections in hospital settings.
Success in Compassionate-Use Cases
Zaynich® also showed strong clinical efficacy in 85 cases of XDR Gram-negative infections treated under compassionate-use programs. These cases were reported across India, the United States, Malaysia, and France, where patients had no safe or effective treatment alternatives available.
The outcomes highlight the urgent global need for new antibiotics and demonstrate the potential of Zaynich® to fill this critical therapeutic gap.
Recognition by Global Clinical Standards Body
As per the press release, the Clinical and Laboratory Standards Institute (CLSI) has granted Zidebactam/Cefepime an investigational susceptible breakpoint of 64 mg/L. This designation indicates the drug’s potential ability to cover clinically important XDR Gram-negative pathogens, particularly in critically ill patients.
Global Regulatory Submissions Under Review
In addition to regulatory progress in India, Wockhardt has already submitted a New Drug Application (NDA) in the United States and a Marketing Authorisation Application (MAA) in the European Union for Zidebactam/Cefepime.
Both submissions are currently in advanced stages of regulatory review, reflecting the growing international interest in this novel antibiotic and its potential role in combating antimicrobial resistance worldwide.