TAHO Pharmaceuticals is pleased to announce the successful completion of the pivotal trial for TAH3311, the first anticoagulant oral dissolving film (ODF). This trial was conducted following detailed discussions and alignment with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), marking a major milestone in the advancement of this innovative product under the 505(b)(2) regulatory pathway.
The trial enrolled 60 healthy volunteers to compare TAH3311 ODF with the Apixaban tablet (brand name Eliquis®) under the bioequivalence (BE) regulatory framework. Apixaban, a Factor Xa inhibitor, is widely used for stroke prevention and treatment of thromboembolic conditions due to its lower dosage requirements and reduced gastrointestinal bleeding risk compared to other anticoagulants. TAH3311 addresses a significant unmet need in this market by offering the first ODF formulation, providing a water-free alternative that is especially beneficial for patients with swallowing difficulties, including the elderly, stroke survivors, and children.
According to IQVIA, the global market for anticoagulants is rapidly expanding, with apixaban achieving U.S. sales of $22.1 billion in 2023, making it the leading small-molecule drug globally and the second best-selling drug overall.* This remarkable growth highlights a significant opportunity for TAH3311 to address existing clinical unmet needs while offering a unique differentiation in an increasingly competitive landscape.
With the trial’s completion, TAHO Pharmaceuticals plans to prepare regulatory submissions in both the United States and Europe. Simultaneously, the company is actively pursuing strategic collaborations with international partners to accelerate the global launch of TAH3311 and maximize its impact in key markets.
“The completion of this pivotal study is a significant step forward in TAHO’s mission to bring innovative Transepithelial Delivery System (TDS) drug delivery solutions to patients worldwide,” said Dr. Howard Lee, Chairman and CEO of TAHO Pharmaceuticals. “As the first ODF formulation in the anticoagulant space, TAH3311 has the potential to transform how these life-saving therapies are delivered, especially for patients who face difficulties with traditional tablet forms.”
