AsianScientist (Nov. 30, 2011) – Tasly Pharmaceuticals Inc. is conducting two global Phase III trials for T89, also known as the Dantonic® pill, that the company hopes will become the first traditional Chinese medicine to receive FDA approval in the United States.
ICON plc, which specializes in clinical development from compound selection to Phase I-IV clinical studies, has been awarded the 3-arm Phase III clinical trial and will also be providing IVRS, data management, and central laboratory services for both global trials.
The Dantonic® pill is a botanical product for the treatment of chronic stable angina pectoris due to coronary heart disease, and is also a modernized version of a traditional Chinese herbal medicine that was approved by the State Food and Drug Administration (SFDA) of China in 1993.
Since then, more than 2 billion doses have been used by over 10 million patients.
“Dantonic® pill global Phase III studies are pioneering projects. There are a number of innovative components in the R&D of this drug,” said Dr. Henry Sun, President of Tasly Pharmaceuticals, Inc., and VP of Tasly Group.
Based in Tianjin, China and founded in May 1994, Tasly Pharmaceuticals Co. Ltd. manufactures and sells its traditional Chinese medicines, generic drugs, vaccines, and personal care products in China and in several other countries.
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Source: ICON plc.
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