Novel Chinese medicine for constipation developed by HKBU authorised by U.S. FDA for clinical trial

HONG KONG SAR – Media OutReach – 25 July 2023 – The Centre for Chinese Herbal Medicine Drug Development (CDD) of Hong Kong Baptist University (HKBU) has made significant progress in developing novel Chinese medicine for treating chronic constipation. With its success in the Investigational New Drug Application to the U.S. Food and Drug Administration (FDA), CDD has been authorised to conduct a phase I clinical trial of the new drug. This is the first time that a new botanical drug developed in Hong Kong was authorised to conduct a clinical trial in the US.

Chronic constipation is a common gastrointestinal disorder affecting approximately 14% of the global population. Currently, many patients with chronic constipation are not completely satisfied with their current treatments due to side effects and/or limited efficacy. In response to the patients’ needs for better therapeutics, CDD has been eyeing the international market and has developed a new drug called CDD-2101, which is based on previous pilot clinical studies and basic research on the traditional Chinese herbal formulation “MaZiRenWan”.

The main ingredients of CDD-2101 include hemp seed, rhubarb, officinal magnolia bark, bitter apricot seed, bran stir-fried immature orange fruit, and white peony root. The HKBU research team collaborated with partners including the University of Chicago and the University of Macau to submit an Investigational New Drug Application for CDD-2101 according to the requirements for botanical drug development of the U.S. FDA and was authorised to conduct a phase I clinical trial.

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