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TAHO Pharmaceuticals Reveals Positive Findings in TAH3311 Study

TAHO Pharmaceuticals has announced positive preliminary outcomes for its pivotal study on TAH3311, the world's first orally dissolvable film (ODF) form of Apixaban, an oral anticoagulant. This pivotal research involved 60 healthy volunteers, with 48 completing the trial. It demonstrated that TAH3311 is bioequivalent to the reference Apixaban tablets (Eliquis®) in both the United States and Europe while fasting. The observed Cmax and AUC values fell within the acceptable regulatory range of 80-125%.

The significance of this study is heightened by the fact that approximately 15 million individuals worldwide experience strokes annually. Notably, close to half of the hospitalized patients face swallowing difficulties, with around 13% developing long-term dysphagia. Conventional anticoagulants often require crushing tablets and mixing them with liquids for easier consumption, which can lead to dosing inaccuracies and discomfort for patients. In contrast, TAH3311 dissolves rapidly in the mouth without the need for water, presenting a more convenient alternative to traditional tablets.

Howard Lee, CEO of TAHO Pharmaceuticals, emphasized the importance of this study, stating, "This pivotal study underlines our commitment to patient-centric innovation. TAH3311 is particularly beneficial for stroke patients, the elderly, children, or anyone with swallowing difficulties needing twice-daily anticoagulant treatment. We believe this new formulation can enhance patient outcomes and minimize the risk of aspiration pneumonia caused by choking when swallowing medication with water."

In the U.S., Apixaban sales reached a staggering $26.1 billion in 2024, with continuous market growth in the anticoagulant sector. TAH3311 is well-positioned as a safer and more accessible therapeutic option, amid these trends. TAHO Pharmaceuticals plans to file market authorization applications in the U.S. and Europe in Q3 2025, while simultaneously exploring strategic collaboration opportunities with international partners to expedite the global launch of TAH3311.

About Apixaban

Apixaban, co-developed by Bristol-Myers Squibb (BMS) and Pfizer under the trade name Eliquis®, is an oral direct factor Xa inhibitor approved for various thromboembolic disorders. Its uses include the prevention of strokes in nonvalvular atrial fibrillation, thromboprophylaxis following hip or knee arthroplasty, and the treatment and prevention of deep vein thrombosis and pulmonary embolism. Apixaban has distinguished itself as a leading new oral anticoagulant due to its noted safety profile.

About TAHO Pharmaceuticals Ltd.

Founded in 2010, TAHO Pharmaceuticals Ltd. leverages its exclusive transdermal delivery system (TDS) to address the limitations of existing medications and develop innovative dosage forms for niche markets. The TDS platform combines advanced technologies for transdermal and transmucosal delivery, enabling the creation of unique dosage forms such as transdermal patches, ODFs, and buccal films. TAHO's product portfolio encompasses a wide array of therapeutic areas, including antithrombotic agents, opioid overdose antidotes, treatments for addiction, pediatric ADHD, and chemotherapy-induced antiemetics. One notable achievement includes TAH4411, an ODF for chemotherapy-induced nausea and vomiting, which became the first product of its kind to receive regulatory approval and enter the market in Japan.