Nanjing, China-based Triastek, a pharmaceutical company, has received FDA investigational new drug clearance to begin clinical studies on its 3D-printed medicine, T21, designed to treat ulcerative colitis.
T21 targets the colon segment of the GI tract. It is a delayed-release, colon-targeted oral tablet made possible through 3D printing.
Triastek has already received clearance for two additional 3D-printed medications.
"We are excited to receive IND clearance to begin clinical trials of this potentially transformative treatment for patients," Senping Cheng, MD, founder and CEO of Triastek, said in a Nov. 21 press release. "Delaying drug release and delivering oral dosage forms to 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 from systemic exposure. We look forward to advancing this treatment into the clinic and appreciate the FDA's support."