CDD-2101: Novel Chinese medicine for the treatment of chronic constipation authorized by U.S. FDA for clinical trial

Project Description

Chronic constipation affects approximately 15% of the global population, significantly impairing quality of life. Existing treatments have notable limitations and side effects, including abdominal pain, diarrhoea, nausea, and headaches. Over 50% of patients report dissatisfaction with current treatments. In response to this unmet need, our research team has developed CDD-2101, a novel drug based on the traditional Chinese herbal formulation "MaZiRenWan."

A randomised, double-blind, placebo-controlled clinical trial in HKSAR demonstrated that patients taking CDD-2101 granules experienced improved complete spontaneous bowel movements (CSBM) and spontaneous bowel movements (SBM) without adverse effects. Following extensive non-clinical and clinical research, we submitted an Investigational New Drug application to the U.S. FDA, adhering to the Botanical Drug Development: Guidance for Industry (December 2016) and the Chinese Pharmacopeia (2020 edition). In April 2024, the U.S. FDA authorized a phase I clinical trial, marking the first authorization for a new botanical drug developed in Hong Kong to conduct a clinical trial in the U.S. The phase I trial, completed in November 2024, confirmed the safety, tolerability, and pharmacokinetics profile of CDD-2101.

We plan to initiate a phase II clinical trial in early 2025 to further evaluate the safety and efficacy of CDD-2101 in patients with chronic constipation in the U.S. Our ultimate goal is to develop CDD-2101 as an FDA-approved botanical drug for the treatment of chronic constipation, enhancing patient outcomes and quality of life worldwide.