TAHO Pharmaceuticals announced the submission of a 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 major regulatory milestone and reflects the company’s commitment to advancing innovative, patient-centric therapies.

TAH3311 represents a groundbreaking advancement in the delivery of apixaban, one of the most commonly prescribed oral anticoagulants. Each year, more than 15 million people worldwide suffer a stroke, and over half of stroke survivors experience dysphagia—a condition that significantly impairs the ability to swallow and increases the risk of pneumonia, malnutrition, dehydration, and reduced quality of life.

Developed using TAHO Pharma’s proprietary Transepithelial Delivery System (TDS) platform, TAH3311 is designed as an easy-to-use oral dissolving film. This novel formulation offers a convenient, effective alternative to traditional tablets, making it particularly beneficial for stroke survivors, elderly patients, and others with swallowing difficulties. By eliminating the need to swallow solid dosage forms, TAH3311 addresses a critical unmet need in anticoagulant therapy, improving treatment adherence and reducing the risk of choking and aspiration pneumonia.

“Our NDA submission for TAH3311 reflects TAHO Pharma’s unwavering dedication to delivering science-driven solutions that meet real patient needs,” said Dr. Lee, CEO of TAHO Pharmaceuticals. “This innovative product has the potential to redefine the standard of care in anticoagulant treatment and significantly enhance patient quality of life.”

This milestone positions TAH3311 for potential U.S. market entry and supports TAHO Pharma’s broader mission to improve therapeutic outcomes through advanced drug delivery technologies. The company is actively seeking strategic global partnerships to accelerate the availability of TAH3311 to patients around the world.