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TAHO Pharmaceuticals Initiates U.S. Phase III Clinical Trial of TAH3311 Antithrombotic Oral Dissolving Film, Dosing First Subjects

Newswire.ca - Tue Nov 19, 12:08AM CST

TAIPEI, Nov. 19, 2024 /CNW/ -- TAHO Pharmaceuticals Ltd. announced the dosing of the first subjects in its U.S. Phase III clinical trial for its lead product, TAH3311, an innovative antithrombotic oral dissolving film (ODF). In July 2023, the U.S. Food & Drug Administration (FDA) accepted TAHO's proposal for a 505(b)(2) NDA submission, based on a single pivotal bioequivalence study comparing the plasma concentration of TAH3311 to the approved tablet formulation. This pivotal, open-label, randomized, crossover trial will enroll 60 subjects.

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