Triastek, a Chinese pharmaceutical company specializing in 3D printing technology, announced that its proprietary 3D printed non-vitamin K antagonist oral anticoagulant (NOAC), T20G, has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) as of February 27, 2025. This regulatory milestone follows an earlier IND approval from China's National Medical Products Administration (NMPA) in January 2024.
"With T20G's IND clearance in both China and the U.S., Triastek has reached a significant milestone in the field of gastric retention drug delivery," said Dr. Feihuang Deng, VP of Technology at Triastek. "These dual regulatory approvals will help accelerate T20G's development and enable us to deliver high-quality pharmaceutical solutions to patients worldwide."
Addressing a Critical Medical Need
Atrial fibrillation (AF), the most common type of heart arrhythmia treated in clinical practice, affects approximately 1%-2% of the general population, with global prevalence estimates ranging between 30 to 100 million cases. Anticoagulation therapy remains the cornerstone intervention for stroke prevention in patients with AF.
NOACs have emerged as preferred pharmacologic agents due to their superior safety and efficacy profiles compared to traditional therapies. This clinical advantage has led major medical organizations, including the American Heart Association (AHA), European Society of Cardiology (ESC), and Asia-Pacific Heart Rhythm Society (APHRS), to recommend NOACs as first-line treatments for stroke prevention in AF patients.
Innovative 3D Printing Technology
T20G is being developed under the FDA's 505(b)(2) New Drug Application (NDA) pathway, with Triastek holding exclusive global intellectual and commercialization rights for this therapeutic candidate.
The product leverages Triastek's proprietary Melt Extrusion Deposition with Micro-Injection Molding (MED&MIM) process and features the company's patented 3D Microstructure for Gastric Retention (3DμS®-GR) platform. This technology enables once-daily oral administration, offering significant advantages over the twice-daily dosing required by reference listed drugs (RLDs).
During its gastric retention phase, T20G facilitates sustained release of the active pharmaceutical ingredient, optimizing absorption in the upper gastrointestinal tract and enhancing oral bioavailability. This technological approach aims to improve patient adherence and simplify dosing management.
Advancing 3D Printed Pharmaceuticals
Since its founding in 2015, Triastek has focused on developing 3D printed solid dosage forms, filing 213 patent applications across 10 countries, with 68 patents granted to date. The company's MED 3D printing technology, combined with 3D microstructure design, provides precise control over drug release characteristics, including delay layer materials, thickness, and composition.
This method allows for varied drug release profiles—immediate, sustained, or pulsed—offering greater flexibility compared to conventional tablet formulation approaches. The technology enables targeted drug delivery to specific areas of the digestive system, potentially improving therapeutic outcomes.
Expanding Pharmaceutical Applications
Beyond T20G, Triastek continues to make strides in the 3D printed pharmaceutical space. Last year, the company collaborated with Eli Lilly to advance the development of 3D printed oral drugs for the gastrointestinal tract, utilizing Triastek's MED technology to create drug release profiles tailored to specific areas of the digestive system.
The FDA clearance for T20G represents not only a significant step forward for Triastek but also highlights the growing potential of 3D printing technology in pharmaceutical development. As this technology continues to mature, it may offer new solutions for complex drug delivery challenges and improve treatment options for patients with various conditions.
With dual regulatory recognition from both U.S. and Chinese authorities, Triastek is positioned to accelerate the development of T20G and potentially bring this innovative anticoagulant formulation to patients worldwide, addressing an important medical need in atrial fibrillation management.
