Imagine baby teeth on 30 year olds!
Human trials for the world’s first tooth-regeneration drug began at Kyoto University Hospital, marking the first Phase I safety study of a medicine designed to stimulate the biological growth of new teeth in adults. The experimental drug, TRG-035, developed by Toregem Biopharma, works by administering a monoclonal antibody that neutralizes the USAG-1 protein, effectively removing the biological “brake” on dormant tooth buds that already exist in every human mouth.
The initial trial involved 30 healthy adult males aged 30 to 64, each missing at least one tooth, to assess safety and determine appropriate dosing. While the drug successfully regrew functional teeth in animal models like mice and ferrets, the primary goal of the 2024–2025 human trial was to confirm safety rather than prove efficacy. Researchers aim to have the treatment commercially available by 2030, with subsequent phases planned to target children with congenital tooth agenesis and older adults who have lost teeth due to disease or aging.