Sun Pharma gets DCGI approval for clinical trial of Nafamostat in Covid-19 patients, Health News, ET HealthWorld


MUMBAI: Sun Pharmaceutical Industries said on Friday it has received approval from the drug control general in India (DCGI) to initiate clinical trial with Nafamostat Mesilate i Covid-19 patients.

Nafamostat is approved in Japan for ameliorating acute symptoms of pancreatitis and treating disseminated intravascular coagulation (DIC).

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A group of researchers from the University of Tokyo in Japan and the Leibniz Institute for Primate Research in Germany recently demonstrated that Nafamostat suppresses a protein at very low concentrations (TMPRSS2) that the Covid-19 virus uses to enter human lung cells.

Another group from Institut Pasteur in South Korea also published data comparing antiviral efficacy of 24 drugs and Nafamostat to SARSCoV-2 in in vitro studies in human lung epithelial derived cells.

In this study, it was found that Nafamostat was the most potent drug and able to inhibit virus entry at very low concentrations, according to findings from Japan and German laboratories.

Globally, there are three clinical trials currently underway to test Nafamostat in Covid-19 patients. These theater leaders are led by the University of Tokyo Hospital in Japan, Gyeongsang National University Hospital in South Korea and a collaborative trial of University Hospital in Padova in Italy, Zurich University in Switzerland and Yokohoma City University in Japan.

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Given the pandemic situation and the urgent need for newer treatment options, Sun Pharma plans to launch the clinical trials as soon as possible. The company has started manufacturing both the active pharmaceutical ingredient and the finished product from Nafamostat in India using technology from its subsidiary, Pola Pharma Japan.

“Sun Pharma is constantly evaluating potential targets that can be explored for the treatment of Covid-19 patients,” said CEO Dilip Shanghvi.

“Nafamostat has shown promising data against SARS-CoV-2 virus in in vitro studies conducted by three independent researchers in Europe, Japan and South Korea. We believe it offers promise in the treatment of Covid-19 patients,” he said in a statement.

Sun Pharma is the world’s fourth largest specialized generic pharmaceutical company and India’s top pharmaceutical company.

By providing products to customers and patients in over 100 countries, its global presence is supported by production facilities across six continents, which are approved by several regulatory agencies.


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