Toregem BioPharma

Toregem BioPharma is a Kyoto, Japan-based biotechnology company spun out of Kyoto University to develop regenerative medicines that restore natural teeth. The company is advancing anti-USAG-1 antibody therapeutics designed to activate dormant tooth buds and induce eruption of new teeth, with an initial focus on congenital tooth agenesis and severe congenital oligodontia. Its lead program, TRG035, is described by the company as a first-in-class tooth regeneration antibody; Toregem has completed a Phase 1 trial in Japan, received orphan drug designation in Japan for severe congenital oligodontia, and has engaged the U.S. FDA through a pre-IND process. Longer term, the company aims to expand beyond rare congenital dental disorders into broader acquired tooth loss indications, potentially offering a biological alternative to dentures and implants.