Mumbai, Sep 11: Drug maker Glenmark Pharmaceuticals on Thursday said it has filed an application with American health regulator US Food and Drug Administrator (USFDA) for starting the first phase of clinical trials for GBR 500, an anti inflammatory compound.
The molecule has the potential can be used broadly as an anti-inflammatory compound and Glenmark intends to initially develop GBR 500 for multiple Sclerosis.
The company expects to complete it by the end of current fiscal, Glenmark Pharmaceuticals said in a regulatory filing to the Bombay Stock Exchange.
"We are excited about the progress made by GBR 500 and glad to have completed all requirements for filing the investigations new drug (IND) for Phase I trials", Glenmark Pharmaceuticals MD and CEO Glenn Saldanha said.
Glenmark is the first Indian company to have a novel biologic molecule in the clinics that could be marketed globally, the filing said adding that the company is the first Indian company to file an IND for a monoclonal antibody with the USFDA.
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