tofacitinib tablet (T21) / Triastek - LARVOL DELTA

A Novel Oral 3D-Printed Delayed- and Extended-Release Tofacitinib (T19) for the Treatment of Rheumatoid Arthritis and Related Inflammatory Diseases (ACR Convergence 2024) - "The PK results demonstrate that T19 achieved the desired product design properties of delayed- and extended-release, as exhibited by the pharmacokinetic profiles and providing peak plasma concentrations in the early morning hours when morning symptoms are most present. The bioequivalence of exposure (AUC) and Cmax observed suggests a potential pharmacokinetic bridge to Xeljanz XRÒ, providing a basis for a 505(b)(2) application for the indications similar to the LD, XeljanzÒ and a potential therapeutic option for the patients with morning symptoms."

Immunology • Inflammation • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

A NOVEL ORAL 3D-PRINTED DELAYED- AND EXTENDED-RELEASE TOFACITINIB (T19) FOR THE TREATMENT OF RHEUMATOID ARTHRITIS AND RELATED INFLAMMATORY DISEASES (EULAR 2024) - "The PK results demonstrate that T19 achieved the desired product design properties of delayed- and extended-release, as exhibited by the pharmacokinetic profiles and providing peak plasma concentrations in the early morning hours when morning symptoms are most present. The bioequivalence of exposure (AUC) and C max observed suggests a potential pharmacokinetic bridge to Xeljanz XR ® , providing a basis for a 505(b)(2) application for the indications similar to the LD, Xeljanz ® and a potential therapeutic option for the patients with morning symptoms."

Immunology • Inflammation • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Triastek Reports Positive FIH Results from Study of T21, a 3D Printed Oral Treatment for Moderate to Severe Ulcerative Colitis (GlobeNewswire) - P=NA | N=NA | "Triastek, Inc...announced they have completed its first human (FIH) study of its third 3D printing drug product, T21, designed to treat moderate to severe ulcerative colitis (UC). Imaging results from the study confirmed that T21 tablets are precisely delivered and released to the target site – the colon – for the drug’s release. The administration of oral medication is generally regarded as the preferred method for patients with UC due to its safety, pain avoidance and patient compliance."

Clinical data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

The Triassic T21 FIH results were released and the feasibility of the original technology platform was verified [Google translation] (GlobeNewswire) - "Nanjing Triassic Pharmaceutical Technology Co., Ltd...announced that the third 3D printing drug product T21 independently developed by the company has completed the world's first human trial (First in human, FIH). meet deadline. T21 is a drug for the treatment of moderate to severe ulcerative colitis (UC), designed to deliver the drug directly to the colonic lesion. The release of the T21 FIH research results marks the first time that the Triassic 3D microstructure colon targeting platform (3D Microstructure for Colon Targeting, 3DμS-CT) has been verified in human trials...At present, T21 has completed the FIH study, and imaging results have confirmed that T21 tablets are accurately delivered to the colon."

Trial completion • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Triastek Receives FDA IND Clearance for 3D Printed Medicine for the Treatment of Ulcerative Colitis (PRNewswire) - "Triastek, Inc...announced today that it has received clearance for its Investigational New Drug (IND) application from the United States Food and Drug Administration (FDA) to initiate clinical studies of the 3D printed medicine, T21, a potential treatment for ulcerative colitis."

IND • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis