Development of a novel botanical drug (DA-9701), as a new prokinetic agent

Functional dyspepsia (FD) is a highly prevalent chronical gastrointestinal disorder that causes a considerable burden to both the patient and society. In the past ten years, several herbal extracts were reported from natural sources in our laboratory. This research was also carried out as a continuous work on bioactive extracts and for the development of prokinetic drugs from natural sources. Based on our prokinetic prescreening data, Corydalis tuber (Corydalis ternata Nakai) and Pharbitis seed (Pharbitis nil Choisy) were selected for this research.

A prokinetic agent, DA-9701 has newly formulated with Corydalis tuber and Pharbitis seed. We evaluated the gastroprokinetic effects of DA-9701 to develop a therapeutic for FD. Corydalis tuber have been used as traditional Chinese medicine (TCM) in the treatment of gastric and duodenal ulcer. Pharbitis seeds are the seeds of Pharbitis nil Choisy of the Convolvulaceae family, has been used as a folk medicine for analgesic effects on the abdomen in the TCM. Oral administration with DA-9701 significantly accelerated gastric emptying and gastrointestinal transit. Furthermore, DA-9701 increased the gastric accommodation in Beagle dogs. These results indicate that DA-9701 has potential as a safe and effective prokinetic agent capable of lessening gastrointestinal symptoms and increasing quality of life in FD patients with abnormalities in GI motor function.

At the present time, product development is in progress for complement of phase III clinical study in 2010, NDA and release of product in 2011.

Acknowledgement: This work was supported by grants from the Plant Diverse Research Center of 21C Frontier R&D programs from the Ministry of Science & Technology in Korea.