Glenmark gets nod for phase II study of novel molecule

New Delhi: Glenmark Pharmaceuticals said it has received nod from Directorate General of Health Services, Central Drugs Standard Control Organisation, to conduct a study for evaluating safety and efficacy of its novel molecule GRC 27864 in patients with osteoarthritic pain.

The company has been granted permission to conduct a Phase IIb dose range finding study to evaluate safety and efficacy of GRC 27864 in patients with moderate osteoarthritic pain, Glenmark Pharmaceuticals said in a statement.

"We are excited that GRC 27864 is moving forward in clinical development and this validates our focus and commitment to develop potential first-in-class molecules," Glenmark Pharmaceuticals Chairman and MD Glenn Saldanha said.

In spite of several available treatment options, there is a significant unmet medical need in chronic pain, he added.

The phase II study is planned in India in 624 patients of osteoarthritis of the knee and hip, Glenmark said.