Business Milestones
2025.10.31
TAHO Pharmaceuticals Submits First Application to the European Medicines Agency for TAH3311, the World’s First Apixaban Orodispersible Film
TAHO Pharmaceuticals Submits First Application to the European Medicines Agency for TAH3311, the World’s First Apixaban Orodispersible Film
TAIPEI, TAIWAN — October 30, 2025 — TAHO Pharmaceuticals Ltd. (“TAHO Pharma”) today announced the submission of its first application to the European Medicines Agency (EMA) seeking approval for TAH3311, the world’s first Apixaban Orodispersible Film (ODF). This milestone marks a significant step forward in TAHO Pharma’s mission to advance innovation in anticoagulant therapy and enhance treatment accessibility for patients worldwide.
According to the European Society of Cardiology, it is estimated that there will be approximately 14 million patients with non-valvular atrial fibrillation (NVAF) by the year 2030, with new cases increasing by 120,000 to 125,000 per year(1).Once diagnosed, AF patients require lifelong treatment with Direct Oral Anticoagulants (DOACs) daily, making adherence essential for effective stroke prevention(2).
TAH3311 demonstrates the same efficacy, indication, and safety profile as Eliquis®, while offering the added convenience of a no-swallow route of administration. It will be the only DOAC formulation that provides a unique opportunity to support ease of administration and improve patient compliance. The EMA submission highlights TAH3311’s potential to improve long-term outcomes through enhanced patient compliance, offering a novel solution for stroke patients and others who face challenges with traditional solid oral dosage forms. Leveraging TAHO’s proprietary Transepithelial Delivery System (TDS), TAH3311 may help reduce the risk of choking and aspiration pneumonia—serious complications frequently associated with dysphagia.
“For people living with strokes or atrial fibrillation, the burden of disease extends far beyond the physical,” said Dr. Howard Lee, CEO of TAHO Pharmaceuticals. “This EMA filing represents an important step in our ongoing efforts to advance stroke prevention
care by broadening treatment options and delivering a patient-centered solution that empowers individuals to live with greater confidence and freedom”
About Apixaban
Apixaban (co-developed by Bristol Myers Squibb and Pfizer under the brand name Eliquis®) is a direct Factor Xa inhibitor approved for several thromboembolic disorders, including stroke prevention in non-valvular atrial fibrillation, thromboprophylaxis following hip or knee replacement surgery, and the treatment and prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE). With notable safety advantages, Apixaban is recognized as a leading novel oral anticoagulant (NOAC) globally.
About TAHO Pharmaceuticals Ltd.
Founded in 2010, TAHO Pharma is a global small-to-medium enterprise (SME) specializing in innovative oral and transdermal drug delivery systems. Through its proprietary Transepithelial Delivery System (TDS) platform, TAHO enables efficient transdermal and transmucosal delivery of small-molecule drugs. The TDS platform provides significant advantages over conventional delivery routes, including tailored release profiles (from rapid onset to sustained delivery), reduced gastrointestinal side effects, enhanced bioavailability, and simplified administration for patients with compliance challenges. With TAHO’s scientifically differentiated technology and clinically meaningful solutions, TAHO is dedicated to advancing patient care and improving quality of life worldwide.
Media Contact:
TAHO Pharmaceuticals
+886-2-2659-8515
ir@tahopharma.com
References:
(1).https://www.escardio.org/Journals/E-Journal-of-Cardiology-Practice/Volume-17/Atrial- fibrillation-in-the-old-very-old-prevalence-and-burden-predisposing-factors-and-complications
(2).https://pmc.ncbi.nlm.nih.gov/articles/PMC10138869/
TAIPEI, TAIWAN — October 30, 2025 — TAHO Pharmaceuticals Ltd. (“TAHO Pharma”) today announced the submission of its first application to the European Medicines Agency (EMA) seeking approval for TAH3311, the world’s first Apixaban Orodispersible Film (ODF). This milestone marks a significant step forward in TAHO Pharma’s mission to advance innovation in anticoagulant therapy and enhance treatment accessibility for patients worldwide.
According to the European Society of Cardiology, it is estimated that there will be approximately 14 million patients with non-valvular atrial fibrillation (NVAF) by the year 2030, with new cases increasing by 120,000 to 125,000 per year(1).Once diagnosed, AF patients require lifelong treatment with Direct Oral Anticoagulants (DOACs) daily, making adherence essential for effective stroke prevention(2).
TAH3311 demonstrates the same efficacy, indication, and safety profile as Eliquis®, while offering the added convenience of a no-swallow route of administration. It will be the only DOAC formulation that provides a unique opportunity to support ease of administration and improve patient compliance. The EMA submission highlights TAH3311’s potential to improve long-term outcomes through enhanced patient compliance, offering a novel solution for stroke patients and others who face challenges with traditional solid oral dosage forms. Leveraging TAHO’s proprietary Transepithelial Delivery System (TDS), TAH3311 may help reduce the risk of choking and aspiration pneumonia—serious complications frequently associated with dysphagia.
“For people living with strokes or atrial fibrillation, the burden of disease extends far beyond the physical,” said Dr. Howard Lee, CEO of TAHO Pharmaceuticals. “This EMA filing represents an important step in our ongoing efforts to advance stroke prevention
care by broadening treatment options and delivering a patient-centered solution that empowers individuals to live with greater confidence and freedom”
About Apixaban
Apixaban (co-developed by Bristol Myers Squibb and Pfizer under the brand name Eliquis®) is a direct Factor Xa inhibitor approved for several thromboembolic disorders, including stroke prevention in non-valvular atrial fibrillation, thromboprophylaxis following hip or knee replacement surgery, and the treatment and prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE). With notable safety advantages, Apixaban is recognized as a leading novel oral anticoagulant (NOAC) globally.
About TAHO Pharmaceuticals Ltd.
Founded in 2010, TAHO Pharma is a global small-to-medium enterprise (SME) specializing in innovative oral and transdermal drug delivery systems. Through its proprietary Transepithelial Delivery System (TDS) platform, TAHO enables efficient transdermal and transmucosal delivery of small-molecule drugs. The TDS platform provides significant advantages over conventional delivery routes, including tailored release profiles (from rapid onset to sustained delivery), reduced gastrointestinal side effects, enhanced bioavailability, and simplified administration for patients with compliance challenges. With TAHO’s scientifically differentiated technology and clinically meaningful solutions, TAHO is dedicated to advancing patient care and improving quality of life worldwide.
Media Contact:
TAHO Pharmaceuticals
+886-2-2659-8515
ir@tahopharma.com
References:
(1).https://www.escardio.org/Journals/E-Journal-of-Cardiology-Practice/Volume-17/Atrial- fibrillation-in-the-old-very-old-prevalence-and-burden-predisposing-factors-and-complications
(2).https://pmc.ncbi.nlm.nih.gov/articles/PMC10138869/