T19 / 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