Osteoporosis is a global aging problem affecting nearly 200 million people worldwide out of which 61 million people reside in India (Sharma and Rao 2000). Aging and postmenopausal bone loss is associated with a progressive decline in the supply of bone forming osteoblasts and not primarily with an increase in bone resorbing osteoclast activity. Since bone remodeling is a tightly controlled physiological process whereby bone resorption by osteoclasts is followed by bone formation by osteoblasts, decline in osteoblast function leads to a net loss of bone in both trabecular and cortical sites (Manolagas 2000). Therefore, any drug that can enhance osteoblast function is a better therapeutic option. Though anti-resorptive therapies such as calcitonin and various SERMs and bisphosphonates are available, anabolic/osteogenic therapies are limited to PTH, NaF and strontium which are also accompanied by undesirable side effects (Rosen and Bilezikian 2001, Lane and Kelman 2003). Thus there is a need for the development of agents that could increase bone mass and strength, thereby reducing the risk of osteoporotic fracture more than the currently available anti-resorptive agents.

To the best of our knowledge, currently identification of anabolic agents aiding in enhanced bone formation is not being studied at the national level. In traditional medicine, there are many natural crude drugs that have the potential to treat bone diseases and moreover a phytotherapeutic approach is useful and relevant to our country. We, in CDRI have identified a natural source for osteogenic agents. Our long term goal is to develop active osteogenic agents from this natural source for therapeutic application. To that end, we possess all requisite in vitro and in vivo assay/model systems as well as expertise pertaining to bone biology.

Highlight Description

CDRI, Lucknow is actively working on the development of osteogenic agents. In this proposal we seek to study CDR2492C002, a plant extract, which is derived from natural source. The extract has shown considerable promise as a source of osteogenic agent(s) since it significantly promoted bone mineral density (BMD) in overiectomized rats as well as isolated pure compounds from the fraction enhanced mineralization of osteoblasts in vitro. Subsequently, four pure compounds have been isolated for further studies. Preliminary in vitro assays such as cell proliferation and survival, differentiation and mineralization in osteoblasts revealed pure compound K007 to be the most effective. Successful completion of this study has the potential to qualify the plant extract (CDR2492C002) as potential bone forming agent.

Importance/Unique Salient Feature

Easily and abundantly available in India, No Biodiversity Issues, Raw material obtained is from the renewable source.

Business Exploitation Potential

We have been able to license one product recently (February 2015) to a Gujarat Based Company for post-menopausal osteoporosis. Clinical trials with positive results are going on. This makes us confident and assured that the identification and scientific validation of CDR2492C002 will definitely help us to move it into the market. The final product will be cost- effective and thus can reach to the masses (women) in India.

Patent Filing is in Process, Document submitted to IPU, CSIR