TAHO Pharmaceuticals announces positive preliminary results from the pivotal study of TAH3311, the world's first Apixaban oral dissolving film (ODF). The study confirmed that TAH3311 is bioequivalent to U.S. and European reference Apixaban tablets (Eliquis®) under fasting conditions, with Cmax and AUC values falling within the regulatory acceptance range (80-125%). The study enrolled 60 healthy volunteers with 48 completing the trial.

These results meet the criteria previously discussed with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) as a basis for filing a New Drug Application (NDA) and a Marketing Authorization Application (MAA), respectively, marking a significant milestone in the regulatory development.

Globally, 15 million people suffer from strokes each year. Nearly half of hospitalized stroke patients experience swallowing difficulties, and approximately 13% develop long-term dysphagia. Conventional anticoagulants often require crushing tablets and mixing with liquids for patients with swallowing difficulties, which can lead to dosing inaccuracies and significant patient inconvenience. TAH3311 dissolves rapidly in the mouth without water, providing a more convenient alternative to tablets. Dr. Howard Lee, Chairman and CEO of TAHO Pharmaceuticals, stated, "This pivotal study underscores our commitment to patient-centric innovation. TAH3311 is especially valuable for stroke patients, the elderly, children or others who have swallowing difficulties and require anticoagulant therapy twice daily. We believe this novel formulation can improve patient outcomes and reduce the risk of aspiration pneumonia caused by choking when swallowing medication with water."

U.S. Apixaban sales reached $26.1 billion in 2024*, and the global anticoagulant market continues to expand. Given these trends, TAH3311 is well positioned as a safer and more accessible treatment option. TAHO Pharmaceuticals plans to file regulatory submissions in both the United States and Europe in Q3 2025. At the same time, the company is actively pursuing strategic collaboration opportunities with international partners to accelerate TAH3311's global launch.
*Source: IQVIA 2024