TAHO Pharma Announces Submission of New Drug Application (NDA) to the U.S. FDA for TAH3311 - The World's First Apixaban Oral Dissolving Film - Represents a Transformational Advancement in Anticoagulant Therapy

TAIPEI, Oct. 1, 2025 /PRNewswire/ -- TAHO Pharmaceuticals Ltd. ("TAHO Pharma") today announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for TAH3311, the world's first Apixaban Oral Dissolving Film (ODF). This submission marks a significant regulatory milestone in TAHO Pharma's mission to bring innovative and accessible therapies to patients worldwide.

TAH3311 is an innovative formulation designed to improve the delivery of apixaban, a widely used anticoagulant. Stroke affects more than 15 million people worldwide each year according to NIH, and over 50% of stroke survivors experience dysphagia, which places them at heightened risk for pneumonia, malnutrition, dehydration, and a reduced quality of life.

Developed on TAHO's proprietary Transepithelial Delivery System (TDS) platform, TAH3311 is formulated as an easy-to-use oral dissolving film (ODF). This patient-friendly format is particularly beneficial for stroke survivors, elderly patients, and others with swallowing difficulties, offering both greater convenience and improved treatment adherence. By eliminating the need for swallowing solid dosage forms, TAH3311 helps reduce the risk of choking and aspiration pneumonia, addressing a critical unmet need in anticoagulant therapy.

"The NDA submission for TAH3311 reflects our unwavering commitment to addressing unmet patient needs through cutting-edge science," said Dr. Lee, CEO of TAHO Pharmaceuticals. "We are proud to offer a patient-centered solution that has the potential to redefine the standard of care in anticoagulant therapy."

This NDA submission is a pivotal step toward U.S. market entry, supporting TAHO Pharma's broader vision to improve patient experiences and therapeutic outcomes through novel drug delivery platforms. TAHO is actively seeking global partnership opportunities to accelerate the product's time to market.

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 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.

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TAHO Pharmaceuticals
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SOURCE Taho Pharmaceuticals