Triastek Secures Third FDA IND Approval in Two Years with Colon-Targeted 3D-Printed Drug T21

On November 18, Nanjing Triastek Pharmaceutical Technology Co., Ltd. (hereinafter referred to as “Triastek”) announced that its independently developed third 3D-printed drug product, T21, has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA). This marks the third IND application approved by the FDA for Triastek within two years. Leveraging 3D printing technology, T21 achieves precise colon-targeted delivery, demonstrating the diversity of Triastek’s drug delivery platforms and validating the broad application potential of emerging technologies in product development.

TRIASTEK’s T21 product is pursuing the 505(b)(2) regulatory pathway for FDA approval in the United States. The reference listed drug is a treatment for ulcerative colitis, a nonspecific inflammatory disease of unknown etiology. Lesions are primarily located in the sigmoid colon and rectum, but may extend to the descending colon or even involve the entire colon. Leveraging colon-targeted delivery technology, T21 precisely delivers the drug to the site of disease, achieving localized administration and local therapeutic effects.

Precise colonic targeted delivery of oral medications remains a significant challenge in the field of pharmaceutical formulation. The industry has long lacked technologies capable of accurately achieving localized drug release in the region spanning from the ileocecal junction to the ascending colon. Traditional formulation techniques typically rely solely on pH-dependent enteric coating to prepare enteric-coated formulations. However, due to inter-individual variations in gastrointestinal pH and the notable pH drop from the ileum to the cecum, relying exclusively on pH-induced coating dissolution makes it difficult to achieve precise colonic release. TRIASTEK’s T21 product employs an innovative dosage form design to achieve colonic targeted delivery. By enabling precise drug release in the colon, it utilizes a lower drug dose than the originator product, thereby reducing systemic drug exposure and minimizing side effects, which enhances safety.

T21 utilizes TRIASTEK’s proprietary MED (Melt Extrusion Deposition) 3D printing technology. Through sophisticated three-dimensional formulation design, this technology not only enables targeted drug release at specific sites within the gastrointestinal tract but also allows for the incorporation of contrast agents during early-stage product development to facilitate the visualization and verification of drug release locations, thereby enhancing the efficiency and success rate of product development. This colon-targeted delivery technology is applicable not only to the development of small-molecule drugs but also to peptides, antibodies, and small nucleic acid therapeutics.

TRIASTEK has developed a variety of drug delivery technologies based on MED 3D printing, such as delayed release with freely adjustable timing, zero-order release with freely adjustable rates, and combination technologies including solubilization, permeation enhancement, pulsatile release, and gastric retention designed for optimal gastrointestinal absorption. It also offers combination products that precisely regulate the release profile of each individual active ingredient. These delivery technologies are realized through pre-designed dosage forms, computational simulation of drug release, and rapid prototyping via 3D printing, thereby addressing the challenges of traditional formulation techniques and providing a rich array of formulation solutions and patented products to meet diverse clinical needs. For instance, TRIASTEK’s first product, T19, employs chronotherapy to enhance drug efficacy, while its second product, T20, enables once-daily dosing of poorly soluble drugs through solubilization and programmed release. Within two years, all three products, including T21, entered clinical trials, demonstrating the diverse application scenarios of TRIASTEK’s 3D-printed drug technology and its capability for the rapid development of complex pharmaceutical products.

TRIASTEK positions itself as a platform company specializing in 3D-printed pharmaceutical technology, employing a business model that combines independently developed products with co-developed offerings. It has established proprietary technologies covering the entire value chain, from drug dosage form design and digital development to continuous manufacturing. Leveraging its advantages in MED 3D drug printing technology, TRIASTEK collaborates with pharmaceutical companies both in China and abroad to develop new molecular entities requiring complex formulation technologies, as well as highly differentiated products for lifecycle management. Currently, TRIASTEK has three self-owned products approved for clinical trials in the United States, among which T19 has also received clinical trial approval in China. In terms of collaborative development, TRIASTEK has partnered with multiple global pharmaceutical companies, including Merck KGaA (Germany) and Eli Lilly and Company, as well as several Chinese pharmaceutical firms.

Dr. Cheng Senping, Founder and CEO of TRIASTEK, stated, “The T21 product reduces drug side effects through dose reduction, offering a safer medication option for patients with ulcerative colitis. Meanwhile, T21’s precise colon-targeted delivery technology is poised to become the optimal local colonic drug delivery system. Through continuous innovation in dosage forms, TRIASTEK will address challenges in drug design and delivery for global partners, developing pharmaceutical products with greater clinical value for patients.”