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TAHO Pharmaceuticals Announces Positive Outcomes for TAH3311

TAHO Pharmaceuticals has recently unveiled encouraging preliminary results from its pivotal study on TAH3311, a revolutionary oral dissolving film anticoagulant. This drug represents a significant advancement as the world's first oral dissolving film (ODF) version of Apixaban, a key cardiovascular medication commonly known under the brand name Eliquis®.

In the trial, conducted with 60 healthy volunteers, the findings demonstrated that TAH3311 is bioequivalent to the established Apixaban tablets under fasting conditions. The clinical data revealed critical metrics, namely Cmax and AUC, within the expected range of 80 to 125%, meeting key criteria set forth by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for new drug application submissions. Out of the original group, 48 participants successfully completed the study, marking a significant milestone in drug development and regulatory pathways.

Stroke remains a leading cause of mortality globally, impacting approximately 15 million individuals each year. Alarmingly, nearly 50% of stroke patients admitted to healthcare facilities experience swallowing difficulties, with nearly 13% suffering from long-term dysphagia. Current anticoagulants pose challenges; they often require crushing and mixing with liquid for patients struggling with swallowing, which may result in incorrect dosing and significant discomfort. TAH3311's unique formulation dissolves quickly in the mouth without the need for water, positioning it as a more convenient alternative to traditional tablets.

Dr. Howard Lee, Chairman and CEO of TAHO Pharmaceuticals, expressed, "This pivotal study underscores our commitment to patient-centered innovations. TAH3311 is particularly valuable for stroke survivors, the elderly, children, and others facing swallowing challenges who require bi-daily anticoagulant therapy. We believe this novel formulation can enhance patient outcomes and reduce the risk of aspiration pneumonia associated with swallowing medications with water."

In terms of market dynamics, U.S. sales of Apixaban reached an impressive $26.1 billion in 2024, with a continuous growth trajectory observed in the global anticoagulant market. Given these trends, TAH3311 is positioned as a safer and more accessible treatment option, which speaks to its broader implications in patient care.

TAHO Pharmaceuticals is planning to submit approval applications for TAH3311 in both the United States and Europe by the third quarter of 2025. The company is also actively exploring strategic partnerships with international organizations to facilitate the global rollout of TAH3311.

About Apixaban

Apixaban, co-developed by Bristol-Myers Squibb and Pfizer and marketed as Eliquis®, is a direct Factor Xa inhibitor approved for various thromboembolic conditions. These include stroke prevention in non-valvular atrial fibrillation, thrombosis prophylaxis after hip and knee replacements, along with treating and preventing deep vein thrombosis (DVT) and pulmonary embolism (PE). With its notable safety profile, Apixaban stands out as the leading novel oral anticoagulant (NOAC) on the market today.

About TAHO Pharmaceuticals Ltd.

Established in 2010, TAHO Pharmaceuticals Ltd. leverages its proprietary Trans-Epithelial Delivery System (TDS) to transcend existing medication barriers, innovating in drug delivery forms for niche markets. The TDS platform conveniently combines advanced transdermal and transmucosal delivery technologies, enabling the development of unique formats such as transdermal patches, ODF, and buccal films. TAHO's extensive product portfolio spans multiple therapeutic areas including antithrombotic agents, opioid overdose treatments, pediatric ADHD solutions, and antiemetics for chemotherapy-induced nausea. Notably, TAH4411, an ODF for chemotherapy-related nausea, pioneered its class in Japan with successful registration and market presence.