Wockhardt shares surged over 14% to ₹2,330 during Monday's trading session, marking a significant milestone following the company's historic regulatory approval. According to reports from NDTV Profit, the stock was rallying over 14% at ₹2,330 apiece as of 9:25 am, with the benchmark BSE Sensex gaining 0.33% to 76,147.58 points during the trading session. The latest development sees Wockhardt shares in focus after the US FDA approved ZAYNICH, a novel intravenous antibiotic combining cefepime and zidebactam for complicated urinary tract infections. This approval represents a historic achievement as ZAYNICH becomes the first New Chemical Entity (NCE) discovered and developed in India to receive US FDA clearance, highlighting the rarity of successful drug discovery programmes emerging from the country's pharmaceutical sector.
The Central Drugs Standard Control Organisation (CDSCO) granted marketing authorization for Wockhardt's novel antibiotic Zaynich on May 28, while the US FDA approved ZAYNICH on May 27, 2026. As reported by NDTV Profit, Zaynich is a combination of Zidebactam and Cefepime given as an injection, while ZAYNICH combines the fourth-generation cephalosporin cefepime with zidebactam. The regulatory approvals clear the way for Wockhardt to market these drugs in India and the US to treat adult patients suffering from complicated urinary tract infections (cUTI), including pyelonephritis. The antibiotic had earlier received Qualified Infectious Disease Product (QIDP) and Fast Track designations from the USFDA. Wockhardt has already secured approval for the drug in India and has filed for regulatory approval in Europe, positioning the company to access a global antibiotic market estimated at around $9 billion.
The approval is supported by results from the pivotal ENHANCE-1 study, a multinational, randomized, double-blind Phase 3 clinical trial evaluating Zaynich's efficacy and safety compared with meropenem in patients with cUTI, including pyelonephritis. According to the company, patients on Zaynich in clinical trials achieved an 89% response rate which includes clinical cure and microbiological eradication compared to just 68.4% for the standard-of-care drug, meropenem. In high-risk patients, Zaynich demonstrated an 89% response rate versus 44% in the meropenem group. The treatment difference was 20.6% with a 95% confidence interval of 12.3 to 29.5. The ENHANCE-1 study enrolled 530 patients across 64 sites spanning the United States, Europe, Latin America, China and India. The approval opens access to a global antibiotic market estimated at around $9 billion, though analysts note that commercialising novel antibiotics has historically been difficult despite the urgent medical need, with newer drugs typically reserved for the most severe cases to avoid overuse and preserve effectiveness.
Zaynich targets metallo-β-lactamase (MBL)-mediated resistance, one of the most prevalent and challenging resistance mechanisms in India, where current options like colistin and polymyxins are frequently limited by severe toxicity and poor efficacy. The drug is specifically designed to address pyelonephritis, a specific type of urinary tract infection that occurs when bacteria ascend from the bladder into one or both kidneys. According to founder-chairman Dr Habil Khorakiwala, the approval represents success in research that must translate into business success, highlighting the company's ambition to convert scientific breakthroughs into commercial success. Wockhardt's antibiotic programme addresses a critical gap in the market left by large global pharmaceutical companies that have scaled back investments in antibiotic research, focusing on combating Gram-negative resistant infections. The approval also shifts attention to Wockhardt's broader pipeline, with the company having several antibiotic candidates under development, including WCK 6777 and Nafithromycin, alongside a biologics portfolio focused on diabetes therapies such as insulin and GLP-1-based treatments.
