National Health Research Institutes Announces FDA approval of Investigational New Drug (IND) Applications for Two Novel Small Molecules, DBPR211 and DBPR114

Institute of Biotechnology and Pharmaceutical Research (IBPR) of the National Health Research Institutes (NHRI) announced that two Investigational New Drug (IND) applications of DBPR211 and DBPR114 have approved by the Taiwan Food and Drug Administration (FDA) this year.

A first-in-human study IND application of DBPR211 for the treatment of type 2 diabetes mellitus (T2DM) has been approved by Taiwan FDA on September 30th, 2017. Another Phase 1 IND application of DBPR211 has been approved by U.S. FDA in 2016.

U.S. FDA and Taiwan FDA have approved a first-in-human Phase 1 clinical trial of IND applications for DBPR114 for the treatment of advanced cancer on July 20th and November 7th, 2017, respectively.

IBPR of the NHRI is an institute aims to engage in cutting-edge biomedical researches for the betterment of health and quality of life for humanity.

About DBPR211

DBPR211 is a potent antagonist selectively acting on the peripheral cannabinoid receptor type 1 (CB1) receptors. It distributes systemically, after oral absorption, with an extremely low brain to plasma ratio. DBPR211 significantly improves insulin resistance, induces weight loss and decreases hepatic steatosis in animal models.

CB1 controls appetite and regulates lipid and glucose metabolism via the central and peripheral action sites, respectively. Blockade of peripheral CB1 receptors improves insulin resistance and protects pancreatic b cell survival with additional benefits in weight loss and reduction of hepatic steatosis. Therefore, targeting the peripheral CB1 receptor without acting on the central CB1 receptor is a potential therapeutic strategy for treating T2DM.

About DBPR114

DBPR114 is an anti-cancer multi-kinase inhibitor that has shown excellent tumor cell growth inhibition and significant tumor size shrinkage has been observed in the in vivo tumor xenograft mouse model of several cancer types. Patients of pancreatic, liver, stomach, and colorectal cancers are to be included as the target populations for further clinical studies.

 Development of DBPR211 and DBPR114

With global patent protection on both DBPR211 and DBPR114, IBPR of the NHRI is seeking for industrial partners for further development toward clinical studies.

 About IBPR of the NHRI

IBPR of the NHRI has established a mission-driven drug discovery and development engine (as a project initiator, accelerator, and developer) with vertical and horizontal coordination and integration. The paradigm has been shifted from early me-too/me-better approach to first-in-class/best-in-class to elevate the Institute’s research capability with a goal being recognized as the “Center of Excellence for Innovative Drug Discovery in Asia, CEIDDA”. For more information, visit .



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