TRG035

TRG035 is an investigational monoclonal antibody developed by Toregem BioPharma, a Kyoto University spin-off, designed to stimulate natural tooth regeneration. The drug targets and neutralizes Uterine Sensitization-Associated Gene-1 (USAG-1), also known as Sclerostin Domain-Containing Protein 1 (SOSTDC1). USAG-1 is a protein that acts as a natural inhibitor of tooth development by antagonizing Bone Morphogenetic Protein (BMP) and Wnt signaling pathways. By blocking this inhibitor, TRG035 aims to activate dormant tooth buds and promote the growth of new teeth. It is primarily being developed for congenital tooth agenesis, specifically severe congenital hypodontia, and is also being explored for potential use in acquired tooth loss. TRG035 entered Phase I clinical trials in September 2024 and has received orphan drug designation in Japan.