Glenmark Pharmaceuticals Limited, one of India's leading research-led, integrated pharmaceutical companies based in Mumbai, has received the international non-proprietary name (INN) 'Melogliptin' for its lead type II diabetes drug candidate GRC 8200, from the World Health Organization (WHO).
This name was selected during the recently held 45th consultation on non-proprietary names and was made by the international panel for pharmacopoeia and pharmaceutical preparations, said a company statement.
GRC 8200, Glenmark's lead DPPIV inhibitor, is a novel, oral DPPIV inhibitor in development for type 2 diabetes. It is currently in phase II clinical trials. Phase I studies showed that the compound was very well tolerated by the subjects at all dosage levels and there were no significant adverse events reported. More than 90 per cent inhibition of the DPP-IV enzyme was observed within one hour at all doses tested. In preclinical studies, the compound appeared to be effective and well tolerated when given at pharmacological doses.
Glenmark has 11 lead molecules at various stages of development in NCE & NBE research. Three of the leads are in phase II whereas eight other leads are into the pre-clinical and discovery stages in the broad areas of inflammation, metabolic disorders and oncology.
The company has generic formulation and API business interests in over 80 countries across the world including the highly regulated markets of USA and Europe. The formulation business spans several product segments such as dermatology, internal medicine, paediatrics, gynaecology, ent, cardiology, diabetes and oncology.
Glenmark's first Asthma/COPD molecule, Oglemilast [GRC 3886], was licensed out to Forest Laboratories and Teijin Pharma Limited for the North American and Japanese markets, respectively, in two landmark deals. The company's second lead GRC 8200, a DPP-IV inhibitor for type II diabetes was out-licensed to Merck KGaA, Germany for the North American, European and Japanese markets. A third molecule targeting pain, GRC 6211, undergoing phase II clinical trials in Europe, has recently been out-licensed to Eli Lilly & Company.