NANJING, China – Triastek, a pioneer in 3D printed pharmaceutical technology, announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for T26 (Itraconazole Tablet), a 3D printed solubility-enhancing drug product. T26 is a 505(b)(2) product indicated for the treatment of mycoses. The product is built upon Triastek's proprietary 3D Microstructure for Solubility Enhancement (3DμS^®-SE) delivery system, which is designed to overcome the oral absorption challenges associated with poorly soluble drugs.

Mycoses represent a growing global public health burden, responsible for over 1.5 million deaths annually and affecting more than 1 billion people worldwide^[1]. Among the various antifungal agents available, itraconazole, a classic triazole antifungal, is widely used in clinical practice for the treatment of onychomycosis and systemic fungal infections such as blastomycosis, histoplasmosis, and aspergillosis.

T26 (Itraconazole Tablet) is developed using Triastek's proprietary Melt Extrusion Deposition (MED^®) 3D printing technology and leverages the 3D Microstructure for Solubility Enhancement (3DμS^®-SE) delivery system. This system combines two core technologies designed to address the absorption challenges associated with poorly soluble drugs. The first involves preparing the active pharmaceutical ingredient (API) into an amorphous solid dispersion (ASD), placing it in a kinetically stable amorphous state that enhances the drug's apparent solubility. The second employs precision-engineered honeycomb microstructures to precisely regulate the tablet's specific surface area, maximizing the duration of supersaturation. The synergistic effect of these two technological approaches achieves the goal of improved bioavailability, offering a more efficient and robust solution for the oral delivery of poorly soluble drugs.

Notably, the 3D printing manufacturing process of T26 eliminates the need for non-environmentally friendly organic solvents such as dichloromethane and avoids the multiple complex steps associated with traditional processes, highlighting the dual advantages of green chemistry and process innovation.

Dr. Feihuang Deng, Dr. Feihuang Deng, Vice President of Technology at Triastek, said: "The FDA clearance of T26 marks an important step for our 3D printing solubility-enhancing technology, further demonstrating the potential of our 3D Microstructure for Solubility Enhancement delivery system. We look forward to advancing T26 through clinical development and applying this platform to additional drug candidates, bringing transformative treatment options to patients with mycoses and other indications."

Reference：

[1] Bongomin, F., Gago, S., Oladele, R. O., & Denning, D. W. (2017). Global and multi-national prevalence of fungal diseases—estimate precision. Journal of fungi, 3(4), 57.

About Triastek：

Global leader in 3D printing pharmaceuticals, Pioneer of new digital pharmaceutical processes.

Founded in July 2015, Triastek is dedicated to the mission of "revolutionizing the pharmaceutical industry, unlocking the next generation of medicine and benefitting patients worldwide." We have created the Melt Extrusion Deposition (MED^®) 3D printing pharmaceutical process, transforming the delivery, development, and production of medicines through digital product development and continuous manufacturing. Leveraging our proprietary 3D printing pharmaceutical technology, we design and develop transformative medicines for patients. Through collaboration with global pharmaceutical companies, we tackle challenging formulation problems, accelerating the development of new drug products and improving the quality of pharmaceuticals. Our vision is to become the world's most influential intelligent pharmaceutical enterprise.