Wockhardt likely to get DCGI nod for respiratory drug by year-end; stock up 5%

The stock price of the company was trading 4.99 percent higher at Rs 686.6 on NSE at 14:01 pm. The stock price of the company was trading 4.99 percent higher at Rs 686.6 on NSE at 14:01 pm.

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26 Aug, 2025 12:21

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Wockhardt  expects its new drug for pneumonia and other respiratory illnesses to get the regulatory nod by the end of this year, the pharma firm’s chairperson Habil F Khorakiwala has said.

The go-ahead by the Drug Controller General of India for WCK 4873 (Nafithromycin) would cap a 25-year-old research programme for the drug, he told CNBC-TV18 on June 28. The R&D programme was aided by the leadership team that has not changed for the past 25 years, he said.

At 2.01 pm, the stock was trading at Rs 686.6 on the National Stock Exchange, up 4.99 percent from the previous close.

WCK 4873 or Nafithromycin is a drug used for community-acquired bacterial pneumonia (CABP) and other bacterial respiratory illnesses.

The phase 3 trials of the drug took place in December. The study compared Moxifloxacin with Nafithromycin. The test showed that Nafithromycin’s usage resulted in a 96.7 percent clinical cure rate, which was better than 94.5 percent for Moxifloxacin.

The pharma company’s investigational drug Zaynich (WCK 5222) has successfully treated a young immuno-compromised patient in the US, which makes it the first case in the country where it has been used to fight a complex infection caused by extreme-drug resistant pseudomonas, the firm said.

Zaynich (Zidebactam/Cefepime) is an investigational antibiotic, categorised under the novel class of 'β-lactam enhancers'.

Khorakiwala said they have also used WCK 5222 for compassionate use in 30 patients In India. “Seen 100 percent success in compassionate use on patients In India,” he said.

The company said it has undertaken global clinical trials for the drug and updates have been good. It expects global approval in 8 months.

According to experts, WCK 5222 is an antibiotic in development that combines a currently approved cephalosporin, cefepime, with a novel β-lactam enhancer (BLE) and zidebactam.

The drug has been granted a susceptibility breakpoint of 64 mg/L for around 10 Gram negative pathogens showing high resistance rates, highest ever, according to the company.

"A high breakpoint of 64 mg/L suggests Zaynich’s (Zidebactam/Cefepime- WCK 5222) strong potential to cover all the clinically important, extreme drug resistant Gram negative pathogens in seriously ill patients."

Currently, Zaynich (Zidebactam/Cefepime- WCK 5222) is undergoing a multinational phase 3 study, which is expected to be completed by FY25, facilitating its global registration and marketing authorization, the company said.