DCGI granted nod to SunPharma for clinical trial with Nafamostat

The Drugs Controller General of India (DCGI) gave green signal to Sun Pharmaceutical Industries to conduct clinical trial with Nafamostat Mesilate for the treatment of COVID-19 patients. Nafamostat has been approved in Japan for the improvement of acute symptoms of pancreatitis and treatment of Disseminated Intravascular Coagulation (DIC).

A demonstration has been also conducted by the group of scientists from the University of Tokyo, Japan and Leibniz Institute for Primate Research, Germanythat Nafamostat, at very low concentrations, suppresses a protein (TMPRSS2) that the COVID-19 virus uses to enter human lung cells.
At present, there are three clinical trials throughout the world to test Nafamostat in COVID-19 patients. The trials are being conducted by the University of Tokyo Hospital, Japan; Gyeongsang National University Hospital (South Korea); and a collaborative trial by University Hospital, Padova, Italy, University of Zurich, Switzerland and Yokohoma City University, Japan (RACONA study).

“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.” said Dilip Shanghvi, Managing Director, Sun Pharma.

Sun Pharma has planned to conduct the clinical trials in wake of urgent conditions against Covid-19. The manufacturing of both API and the finished product of Nafamostat has been started by the company in India, using technology from its subsidiary, Pola Pharma Japan.

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