Glenmark Pharmaceuticals Ltd today said that its new chemical entity, indicated for the treatment of neuropathic, osteoarthritis and other inflammatory pain disorders, has successfully completed Phase I trials in Europe.
"The phase I study was conducted on 80 healthy human subjects using escalating single and multiple oral doses with the objective of assessing safety, tolerability and pharmacokinetics of our new chemical entity (GRC 10693)," the company said in a filing to the Bombay Stock Exchange.
Phase I clinical trial is the first exposure of new compound on human beings after testing it on animals, to find out the safety and efficacy of new compounds on human body.
Initially, the company intended to develop GRC 10693 for neuropathic pain relief as the primary indication. It is going to initiate phase II trials later this year, Glenmark said.
"This is a significant achievement for our organisation as GRC 10693 will be our fourth molecule which will enter phase II trials," Glenmark Pharmaceutical Managing Director and CEO Glenn Saldanha said.
