The company’s first 3D printed drug product, has been approved for drug clinical trials (IND) by the National Pharmaceutical Agency (NMPA).
The product was registered in China as a Class 2.2 modified new drug and is the first known 3D printed drug product to receive IND approval in China.
According to the report, T19 is a 3D-printed drug with global intellectual property designed and developed by Triadic. The product is designed to address the circadian rhythm of rheumatoid arthritis symptoms based on the principles of chronotherapy. When patients take T19 at bedtime, the drug concentration in the blood peaks in the morning when the symptoms of the disease, such as pain, joint stiffness and dysfunction, are most severe, and maintains its daytime blood concentration, thus achieving the best drug treatment effect.
IT Home has learned that T19 was previously registered with the FDA through the 505 (b)(2) pathway and received an IND in 2021, making it the second known 3D-printed drug product to be publicly registered with the FDA in the United States. The product will be followed by clinical studies in the U.S. and China and a marketing application (NDA) to the FDA and NMPA, respectively.
Triastek’s new proprietary 3D printing technology platform includes dosage form design, digital pharmaceutical product development and smart manufacturing. Triastek has the world’s largest product line based on 3D printing technology and has completed 6 rounds of funding.