TAHO Pharmaceuticals announces positive preliminary results from the pivotal study of TAH3311, the world's first oral resolution film (ODF) of apixaban. The study confirmed that TAH3311 is bioequivalent to the US and European reference tablets of apixaban (Eliquis®) under fasting conditions, with Cmax and AUC levels within the acceptable range (80-125%). The study involved 60 healthy volunteers, 48 of whom completed the study. These results meet the criteria previously discussed with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) as the basis for submitting a New Drug Application (NDA) and Marketing Authorization Application (MAA) respectively, marking an important milestone in the development of regulatory authorities.

Worldwide, 15 million people suffer a stroke every year. Nearly half of stroke patients hospitalized have difficulty swallowing, and about 13% develop long-term dysphagia. Conventional anticoagulants often need to be crushed and mixed with liquid in patients with swallowing difficulties, which can lead to dosage errors and significant inconvenience for patients. TAH3311 dissolves quickly and without water in the mouth, making it 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 particularly valuable for stroke patients, the elderly, children or others who have difficulty swallowing and need anticoagulant therapy twice a day. We believe this novel formulation can improve patient outcomes and reduce the risk of aspiration pneumonia caused by swallowing medication with water."

Apixaban's sales in the U.S. reached $26.1 billion* in 2024, and the global anticoagulant market continues to grow. 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 the third quarter of 2025. At the same time, the company is actively seeking strategic cooperation opportunities with international partners to accelerate the global adoption of TAH3311.
*Source: IQVIA 2024