Zaynich, Wockhardt‘s new antibiotic for combating multidrug-resistant pathogens, is the first fully indigenously developed Indian new chemical entity to secure US FDA approval. Spurred by its success, the Indian pharmaceutical industry may just start focusing on drug discovery, writes Banasree Purkayastha
l What are the milestones met by this new drug?
WOCKHARDT’S NEW DRUG Zaynich — a first-in-class breakthrough antibiotic — has received approval from the US Food and Drug Administration (FDA). This means the drug can be prescribed by doctors for treatment of patients in the US suffering from complicated urinary tract infections caused by susceptible Gram-negative pathogens.
Zaynich had previously received Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA. The approval by USFDA comes on the back of India’s Central Drugs Standard Control Organisation (CDSCO) granting authorisation for the marketing of the novel antibiotic here. Wockhardt has also submitted a marketing authorisation application to the European Medicines Agency.
More importantly, this is the first new chemical entity (a new active ingredient never approved for human use before) fully developed and commercialised by an Indian company to receive an FDA approval, representing a historic milestone not only for Wockhardt, but for the Indian pharmaceutical industry.
l How does Zaynich combat superbugs?’
ZAYNICH IS AN intravenous antibiotic, combining fourth generation cephalosporin cefepime and zidebactam, for the treatment of adults with complicated urinary tract infections, including pyelonephritis. The novel drug targets multiple penicillin binding proteins (PBP 1a/b, 2 and 3) simultaneously.
This unique, multi-target synergy provides bactericidal activity against the most challenging drug-resistant Gram-negative bacteria for which there are currently very limited treatment options. It has been indicated to work against E coli, Klebsiella pneumoniae, Proteus mirabilis, Enterobacter cloacae complex and Pseudomonas aeruginosa.
The FDA approval was based, in part, on the 96.8% efficacy rate shown in the Phase three study that enrolled 530 patients from the US, Europe, Latin America, China and India.
l Why is this new antibiotic needed?
ANTIMICROBIAL RESISTANCE IS one of the most urgent global health threats but most big companies have exited antibiotic research entirely. A growing number of cUTIs are caused by antimicrobial-resistant bacteria, including multidrug-resistant bacteria, which are associated with morbidity and mortality. More than 2.8 million antimicrobial-resistant infections occur each year in the US alone, resulting in more than 35,000 deaths.
“Zaynich is a life-saving therapeutic option, particularly in carbapenem-resistant infections where current treatment options such as colistin and polymyxins are limited by significant toxicity and suboptimal efficacy,” said Wockhardt in a statement. Importantly, Zaynich is positioned to address metallo-ß-lactamase (MBL)-mediated resistance, one of the most prevalent and challenging resistance mechanisms in India. The company has been working on discovering new antibiotics for the last 27 years.
l Other antibiotics in the pipeline
WOCKHARDT HAS A pipeline of six antibiotics at various stages of clinical development and commercialisation; three of them target infections caused by Gram-negative pathogens and three those by Gram-positives. All six antibiotics have been granted QIDP designation by the US FDA. In 2024, it launched India’s first indigenously developed antibiotic Miqnaf with the support of Biotechnology Industry Research Assistance Council.
l Market potential of Zaynich
WOCKHARDT IS EYEING a US launch within eight months. The India launch could be even earlier. Revenues from Zaynich are likely to start rolling in from FY28. Wockhardt has the patent for Zaynich till 2038, and it expects Zaynich to help it get 20% of the $9-billion global antimicrobial resistance market. India’s anti-bacterial market was valued at Rs 24,142 crore in April 2026, per market tracker Pharmarack.
l Will Wockhardt’s success spur drug discovery in India?
WHILE THE INDIAN pharmaceutical industry is the third-largest producer by volume, with exports reaching $30.5 billion in FY25, the focus has been on generic medicines and to a limited extent, biosimilars. Most firms prefer to pursue licensing deals with their global counterparts for development and commercialisation of their new molecules. For instance, Orchid Pharma got FDA approval for its new chemical entity enmetazobactam but licensed it out to a German biotech firm.
Glenmark signed a $700 million out-licensing deal last year with AbbVie for its cancer molecule. However, Zaynich’s success in the global antimicrobial resistance market may nudge other pharma majors to look at novel drug discovery and development. The government has also been nudging the industry towards innovation and research. The Biopharma Shakti Initiative with an outlay of Rs 10,000 crore is aimed at advancing capabilities in biopharmaceutical innovation.