Clinical trial aims to regrow real teeth by activating a third set of hidden tooth buds everyone has
Tooth loss touches nearly a quarter of adults over 60, and until now the fix has meant implants, dentures or bridges. That could be changing. A Japanese biotech is running human trials right now on a drug designed to grow a real, natural tooth back in the socket where one is missing, by waking up a dormant biological pathway everyone already has.
How the Tooth Loss Drug Works
Almost no one knows this, but every human carries a dormant third set of tooth buds. Most people never grow them because a protein called USAG-1 keeps that development switched off. Toregem BioPharma, a Kyoto University spinout founded in 2020, built a neutralizing antibody called TRG-035 to block that protein and unlock those hidden buds.
The proof of concept arrived in 2021, when the company showed its antibody restored teeth in mice born without them due to a gene deficiency affecting dental development. Japan’s Ministry of Health, Labour and Welfare has since granted TRG-035 Orphan Medicinal Product designation.
Where the Human Trials Stand
Human trials began in September 2024 at Kyoto University Hospital. The first phase is testing safety and dosing in 30 healthy adult men aged 30 to 64, each missing at least one molar, according to Toregem’s own trial announcement.
Toregem is starting with people who have severe congenital hypodontia, then plans to expand into broader cases of tooth loss. The company has raised roughly $29 million in total funding and is already planning Phase 2, per Futurism’s reporting on its latest round. Public commercialization is targeted for 2030.
Why Tooth Loss Matters at This Scale
The World Health Organization estimates complete tooth loss affects almost 7% of adults aged 20 and older worldwide. For adults 60 and older, that figure climbs to 23%.
Zoom out further and oral diseases affect an estimated 3.5 billion people. According to the same WHO data, that total exceeds the combined burden of cancer, diabetes and cardiovascular disease as global health concerns. It also outpaces chronic respiratory disease and mental disorders. That scale is what makes a regenerative drug significant beyond its rare-disease starting point.
How to Spot Early Signs of Tooth Loss Risk
Loose or shifting teeth are often the most obvious warning. Receding gums, persistent bad breath and bleeding while brushing or flossing round out the common signs of the gum disease and decay that eventually lead to tooth loss. New gaps between teeth, or a bite that suddenly feels different, are worth a dentist visit rather than a wait-and-see approach.
What to Do While the Science Catches Up
The drug is not available. It remains in early-phase human trials, and no one should expect it in a dentist’s chair anytime soon. Basic daily habits still do far more to prevent tooth loss than anything in the pipeline. Brushing twice a day, flossing and treating gum disease early can stop most preventable cases before they start.
Regular dental checkups remain the single most effective safeguard, since decay and gum disease are highly treatable when caught early. The drug that could one day regrow real teeth is still years away. What matters more right now is staying on top of the same oral microbiome research shaping how experts think about whole-mouth health today.
This article was created by content specialists using various tools, including AI.
