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Sun Pharmaceutical Industries has secured approval from the Drugs Controller General of India (DCGI) to conduct a clinical trial of pancreatitis drug, Nafamostat Mesilate, to treat Covid-19 patients in the country.
The drug holds approval in Japan to improve acute symptoms of pancreatitis and treat Disseminated Intravascular Coagulation (DIC).
Researchers at the University of Tokyo, Japan and Leibniz Institute for Primate Research, Germany have identified Nafamostat as a potential Covid-19 treatment. This comes after very low concentrations of the drug suppressed TMPRSS2 protein required by the coronavirus for entry into human lung cells.
Researchers from South Korea compared antiviral efficacy of 24 drugs and Nafamostat against Covid-19 in-vitro in human lung epithelial derived cells.
During these Korean studies, Nafamostat was observed to be the most potent drug and showed ability to block virus entry at very low concentrations. The findings are consistent with those from Japan and German labs.
Three clinical trials of the drug are currently ongoing in Covid-19 patients.
The studies are being led by the University of Tokyo Hospital in Japan, Gyeongsang National University Hospital in South Korea, and a collaborative trial by University Hospital in Italy, University of Zurich in Switzerland, and Yokohoma City University in Japan.
Sun Pharma managing director Dilip Shanghvi said: “Sun Pharma is constantly evaluating potential targets that can be explored for treating Covid-19 patients.
“Nafamostat has shown promising data against SARS-CoV-2 virus in in-vitro studies conducted by three independent groups of scientists in Europe, Japan and South Korea. We believe it holds promise in the treatment of Covid-19 patients.”
Sun Pharma intends to launch the clinical trials soon. The company has started manufacturing the API and the finished product of the drug in India using technology from its subsidiary, Pola Pharma Japan.