Pharma Focus Europe

HiST Pharma Announces U.S. FDA Approval to Start a Phase III Clinical Trial of TC Cream - the World's First Plant-Based "Small Molecule" Drug to Treat Psoriasis Vulgaris

Monday, May 22, 2023

HiST Pharma, through its wholly owned Psoriasis Research Institute of Guangzhou (PRIG), announces today that it has received approval from the U.S. Food and Drug Administration (FDA) to develop its new investigational drug (IND) Include TC Cream for the treatment of patients with psoriasis vulgaris in a multicenter phase III clinical trial. Following the previously completed phase II b study (NCT03372811), this phase III study will be conducted in the United States.

“The FDA-approved initiation of a Phase III clinical trial for our IND marks another major milestone for the Company as it enters the final phase of the world's first herbal drug development for the treatment of psoriasis, now the Phase II b trial . has been successfully completed." - Liping Yang, CEO of HiST Pharma

This announcement is official in its original source language. Translations are only intended as a reading aid and must be compared with the text in the source language, which is the only one legally valid.

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