Sør-Trøndelag University College

HiST Pharma Announces U.S. FDA Approval to Initiate Phase III Clinical Study With TC Cream – World’s First Botanical Small-Molecule Drug That Treats Psoriasis Vulgaris

Retrieved on: 
Wednesday, May 17, 2023

HiST Pharma through its wholly-owned Psoriasis Research Institute of Guangzhou (PRIG) announces today that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) TC Cream to launch a U.S.-based multicenter Phase III clinical study to treat patients with psoriasis vulgaris, following a previously completed Phase IIb trial (NCT03372811).

Key Points: 
  • HiST Pharma through its wholly-owned Psoriasis Research Institute of Guangzhou (PRIG) announces today that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) TC Cream to launch a U.S.-based multicenter Phase III clinical study to treat patients with psoriasis vulgaris, following a previously completed Phase IIb trial (NCT03372811).
  • “The initiation of a Phase III clinical trial for our IND, approved by the FDA, is another key milestone for the company in the final stage of our world’s first botanical new drug development following a successful Phase IIb trial for the treatment of psoriasis."
  • “The initiation of a Phase III clinical trial of our IND in the U.S. is another key milestone for the company in the final stage of our world’s first botanical new drug development.
  • With the clinical clearance from the FDA, we are one step closer to bringing TC to benefit millions of patients affected by this debilitating disease.