Triastek Receives FDA IND Clearance for 3D Printed Medicine for Ulcerative Colitis

Triastek Receives FDA IND Clearance for 3D Printed Medicine for Treatment of Ulcerative Colitis

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  • FDA’s Third IND Clearance for a Triastek 3D Printed Drug
  • T21, a potential novel treatment capable of delivering drugs targeted to the colon

NANJING, China, November 21, 2022 /PRNewswire/ — Triastek, Inc. (“Triastek”), a global healthcare company that pioneered the 3D printing of pharmaceuticals with its patented technology, Melt Extrusion Deposition (MED®), today announced that it has received clearance for its application for Investigational New Drug (IND) by the US Food and Drug Administration (FDA) to initiate clinical studies of the 3D-printed drug, T21, a potential treatment for ulcerative colitis.

“We are very pleased to receive clearance from the IND to initiate clinical trials of this potentially transformative treatment for patients,” said Dr. Senping Cheng, founder and CEO of Triastek. “Delaying drug release and delivery of oral dosage forms into the colon is challenging, so T21 offers a promising new option for patients by providing site-specific drug delivery and localized drug effect, mitigating potential side effects of systemic exposure. We are looking forward to bringing this treatment to the clinic and are grateful for the support of the FDA. “

T21 is a potential novel treatment capable of delivering drugs targeted to the colon. With a unique 3D dosage form design, T21 can reach the targeted segment of the colon of the GI tract, allowing a lower drug dose to be used than the reference drug, providing systemic exposure. Using 3D printing, radioimaging agents embedded in specific components of the dosage form were used in early formulation development to assess and confirm the localization of drug release in the gastrointestinal tract. This novel process can be used in the development of future drugs that target specific segments of the GI tract to increase the efficacy and success rate of product development. The colon-targeted delayed-release oral tablet technology platform can be used not only to develop small-molecule drugs, but also for peptide drugs.

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Triastek's Three Products Enter the Clinical Development Phase within Two Years

Triastek had already received IND clearance from the FDA for its T19 and T20 products for the treatment of rheumatoid arthritis and cardiovascular and coagulation disorders, respectively. Triastek continues to demonstrate the broad applicability of its MED® technology by advancing products that solve a wide range of drug delivery challenges in multiple therapeutic areas.

About Triastek

Triastek, Inc. is a global healthcare company developing medicines using its own pioneering 3D printing technology. Triastek is dedicated to revolutionizing the development and manufacturing of pharmaceuticals and unlocking the next generation of medicines through 3D printing technology. Its cutting-edge technology, called Melt-Extrusion Deposition (MED®), facilitates drug development in a layered construction to enable controlled and precise delivery of treatments. This optimized treatment design helps control when, where, and how much medication is released in the body, ensuring more targeted and effective delivery.

About Melt-Extrusion Deposition (MED®)

The impression Melt-Extrusion Deposition (MED®) 3D is an end-to-end additive manufacturing technology that continuously converts raw materials into powdered softening/melting states, followed by precise layer-by-layer deposition to produce objects with well-designed geometric structures.

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