TAHO Pharmaceuticals Announces Positive Results for TAH3311, a Breakthrough Oral Dissolving Film Anticoagulant

TAHO Pharmaceuticals Unveils Promising Results for TAH3311

TAHO Pharmaceuticals recently shared exciting updates regarding their pivotal study of TAH3311, which is notable for being the first oral dissolving film (ODF) anticoagulant in the world, specifically based on apixaban. This groundbreaking development could revolutionize treatment options for patients at risk of strokes and other thromboembolic conditions.

The study yielded preliminary positive results, confirming that TAH3311 demonstrated bioequivalence to the traditional tablets of Eliquis® (the brand name for apixaban) commonly used in both the United States and Europe. The crucial metrics, including the maximum concentration (Cmax) and the area under the curve (AUC), fell squarely within regulatory acceptance ranges of 80-125%. In this study, 60 healthy volunteers participated, out of which 48 successfully completed the trial, setting the stage for upcoming regulatory submissions.

The significance of TAH3311 extends beyond mere equivalence; the film provides a more patient-friendly alternative, particularly for individuals struggling with swallowing pills. Each year, approximately 15 million people suffer from strokes globally, and a substantial portion of these patients face challenges when it comes to oral medications. Conventional anticoagulants often necessitate the crushing of tablets, which can lead to dosage inaccuracies and pose significant discomfort for patients. Unlike these traditional forms, TAH3311 dissolves rapidly in the mouth without the need for water, potentially enhancing compliance and comfort for patients, especially the elderly, children, or anyone diagnosed with dysphagia.

Dr. Howard Lee, the President and CEO of TAHO Pharmaceuticals, emphasized the company's commitment to patient-centered innovation, stating, “This fundamental study underscores our dedication to developing solutions for patients facing unique challenges. TAH3311 is particularly beneficial for stroke survivors, the elderly, children, and any patients requiring regular anticoagulation therapy.” It also addresses the pressing issue of aspiration pneumonia risk when swallowing medications with liquids—an important consideration for sensitive populations.

In terms of market potential, the U.S. apixaban sales reached a staggering $26.1 billion in 2024, with the global anticoagulant market steadily expanding. TAHO Pharmaceuticals is strategizing to introduce TAH3311 as a safer and more accessible treatment option. Their plans include filing regulatory applications in both the U.S. and Europe in the third quarter of 2025. Furthermore, TAHO Pharmaceuticals is actively searching for strategic collaborators to expedite the global rollout of TAH3311.

Understanding Apixaban

Apixaban is a direct factor Xa inhibitor developed jointly by Bristol-Myers Squibb (BMS) and Pfizer, marketed under the name Eliquis®. Its clinical applications include managing various thromboembolic disorders such as stroke prevention in nonvalvular atrial fibrillation and thromboprophylaxis post-hip or knee replacement surgery. Given its notable security advantages, apixaban has emerged as a leading novel oral anticoagulant (NOAC).

About TAHO Pharmaceuticals

Founded in 2010, TAHO Pharmaceuticals leverages its proprietary transdermal delivery system (TDS) to devise innovative dosage forms that overcome existing medication limitations. This cutting-edge platform combines advanced transdermal and transmucosal technologies, allowing for a unique array of dosage forms, including ODFs and transdermal patches. The company’s extensive product pipeline spans multiple therapeutic areas, including anticoagulants, opioid overdose treatments, ADHD in pediatrics, and chemotherapy-induced nausea. Notably, TAH4411, an ODF for chemotherapy-induced nausea and vomiting, was the first of its kind to receive regulatory approval in Japan.