Business Milestones
2025.05.09
TAHO Pharmaceuticals’ TAH3311, The First and Only Anticoagulant Oral Film, Achieves Pivotal Study Success
Taipei — May 8, 2025
TAHO Pharmaceuticals Ltd. announces the successful final results of the pivotal study for TAH3311, the world’s first Apixaban oral dissolving film (ODF). Building on promising early findings, TAH3311 leverages TAHO’s innovative Transepithelial Delivery System (TDS) to offer a game-changing solution: a thin film that dissolves instantly on the tongue without water, making anticoagulant therapy simpler and more accessible for patients, especially those with swallowing difficulties. Conducted from November 2024 to January 2025, the study was designed in close discussion with the U.S. FDA and European EMA. It confirmed that TAH3311 matches the performance of Eliquis ® tablets (U.S. and EU versions) under fasting conditions, meeting regulatory standards. Compared to U.S. Eliquis ® , TAH3311 achieved geometric mean ratios of 95.3% for C max (90% CI: 90.32–100.46), 97.7% for AUC 0-t (90% CI: 94.29–101.29), and 98.4% for AUC0- (90% CI: 95.12–101.73). Compared to EU Eliquis ® , the ratios were 97.7% for C max (90% CI: 92.10–103.58), 101.4% for AUC 0-t (90% CI: 98.11–104.82), and 101.9% for AUC0- (90% CI: 98.59–105.24). These results pave the way for New Drug Application (NDA) and Marketing Authorization Application (MAA) submissions to the FDA and EMA, bringing TAH3311
closer to transforming lives worldwide.
Each year, 15 million people worldwide suffer strokes, with nearly half facing swallowing difficulties during hospitalization and 13% living with long-term dysphagia. For these patients, the elderly, and others, traditional anti-blood clot tablets are challenging, often requiring crushing and mixing with liquids, which risks dosing errors and increases the burden of care. TAH3311 changes everything. This innovative oral dissolving film (ODF) melts quickly on the tongue without water, ensuring precise dosing, ease of use, and a lower risk of choking-related complications like aspiration pneumonia, bringing hope to millions.
With Apixaban’s U.S. sales hitting $26.1 billion in 2024 (IQVIA data), the global anti-blood clot market is thriving. TAH3311 is poised to revolutionize treatment and transform lives. TAHO is delighted to be advancing regulatory submissions to the FDA and EMA, while forging partnerships to bring TAH3311 to patients worldwide. At TAHO, we’re driven by a passion for innovative, compassionate solutions that make a lasting difference.
About Apixaban
Apixaban (co-developed by BMS and Pfizer under the brand name Eliquis®) is a direct factor Xa inhibitor and has been approved for clinical use in several thromboembolic disorders, including stroke prevention in non-valvular atrial fibrillation, thromboprophylaxis after hip/knee replacement, and the treatment and prevention of deep vein thrombosis or pulmonary embolism. With notable safety advantages, it is the leading novel oral anticoagulant (NOAC).
About TAHO Pharmaceuticals Ltd.
Founded in 2010, TAHO Pharmaceuticals Ltd. leverages its proprietary Transepithelial Delivery System (TDS) to overcome the limitations of existing drugs and develop innovative dosage forms for niche markets. The TDS platform combines advanced transdermal and transmucosal delivery technologies, enabling the development of unique dosage forms such as transdermal patches, ODF, and buccal films. TAHO’s diverse product portfolio spans a variety of therapeutic areas, including antithrombotic agents, opioid overdose antidotes, addiction treatments, pediatric ADHD, and chemotherapy-induced antiemetics. Among its notable achievements, TAH4411, an ODF for chemotherapy-induced nausea and vomiting, became the first product of its kind to receive regulatory approval and be commercialized in Japan
Media Contact:
TAHO Pharmaceuticals
+886-2-2659-8515
ir@tahopharma.com
TAHO Pharmaceuticals Ltd. announces the successful final results of the pivotal study for TAH3311, the world’s first Apixaban oral dissolving film (ODF). Building on promising early findings, TAH3311 leverages TAHO’s innovative Transepithelial Delivery System (TDS) to offer a game-changing solution: a thin film that dissolves instantly on the tongue without water, making anticoagulant therapy simpler and more accessible for patients, especially those with swallowing difficulties. Conducted from November 2024 to January 2025, the study was designed in close discussion with the U.S. FDA and European EMA. It confirmed that TAH3311 matches the performance of Eliquis ® tablets (U.S. and EU versions) under fasting conditions, meeting regulatory standards. Compared to U.S. Eliquis ® , TAH3311 achieved geometric mean ratios of 95.3% for C max (90% CI: 90.32–100.46), 97.7% for AUC 0-t (90% CI: 94.29–101.29), and 98.4% for AUC0- (90% CI: 95.12–101.73). Compared to EU Eliquis ® , the ratios were 97.7% for C max (90% CI: 92.10–103.58), 101.4% for AUC 0-t (90% CI: 98.11–104.82), and 101.9% for AUC0- (90% CI: 98.59–105.24). These results pave the way for New Drug Application (NDA) and Marketing Authorization Application (MAA) submissions to the FDA and EMA, bringing TAH3311
closer to transforming lives worldwide.
Each year, 15 million people worldwide suffer strokes, with nearly half facing swallowing difficulties during hospitalization and 13% living with long-term dysphagia. For these patients, the elderly, and others, traditional anti-blood clot tablets are challenging, often requiring crushing and mixing with liquids, which risks dosing errors and increases the burden of care. TAH3311 changes everything. This innovative oral dissolving film (ODF) melts quickly on the tongue without water, ensuring precise dosing, ease of use, and a lower risk of choking-related complications like aspiration pneumonia, bringing hope to millions.
With Apixaban’s U.S. sales hitting $26.1 billion in 2024 (IQVIA data), the global anti-blood clot market is thriving. TAH3311 is poised to revolutionize treatment and transform lives. TAHO is delighted to be advancing regulatory submissions to the FDA and EMA, while forging partnerships to bring TAH3311 to patients worldwide. At TAHO, we’re driven by a passion for innovative, compassionate solutions that make a lasting difference.
About Apixaban
Apixaban (co-developed by BMS and Pfizer under the brand name Eliquis®) is a direct factor Xa inhibitor and has been approved for clinical use in several thromboembolic disorders, including stroke prevention in non-valvular atrial fibrillation, thromboprophylaxis after hip/knee replacement, and the treatment and prevention of deep vein thrombosis or pulmonary embolism. With notable safety advantages, it is the leading novel oral anticoagulant (NOAC).
About TAHO Pharmaceuticals Ltd.
Founded in 2010, TAHO Pharmaceuticals Ltd. leverages its proprietary Transepithelial Delivery System (TDS) to overcome the limitations of existing drugs and develop innovative dosage forms for niche markets. The TDS platform combines advanced transdermal and transmucosal delivery technologies, enabling the development of unique dosage forms such as transdermal patches, ODF, and buccal films. TAHO’s diverse product portfolio spans a variety of therapeutic areas, including antithrombotic agents, opioid overdose antidotes, addiction treatments, pediatric ADHD, and chemotherapy-induced antiemetics. Among its notable achievements, TAH4411, an ODF for chemotherapy-induced nausea and vomiting, became the first product of its kind to receive regulatory approval and be commercialized in Japan
Media Contact:
TAHO Pharmaceuticals
+886-2-2659-8515
ir@tahopharma.com