The world's first human trial of a drug that can regenerate teeth will begin after a few months, less than a year after the news of its success in animals. This paves the way for the drug to be on the market as early as 2030
The trial, which will take place at Kyoto University Hospital from September to August 2025, will treat 30 men between the ages of 30 and 64, who are missing at least one molar. The intravenous treatment will be tested for its efficacy on human dentition after successfully growing new teeth in ferret and mouse models without significant side effects.
„We want to do something to help those who suffer from missing or missing teeth,” said lead researcher Katsu Takahashi, head of the Department of Dentistry and Oral Surgery at Kitano Hospital. “Although there has been no treatment to date that provides a permanent cure, we believe that people's expectations for tooth growth are high.“
After this 11-month first phase, researchers will test the drug on patients aged 2 to 7 years who are missing at least four teeth due to congenital dental failure, which is estimated to affect 1% of people. The team is now recruiting candidates for this phase IIa trial.
Next, the researchers are considering expanding the trial to include people with partial edentulism, or people who are missing one to five permanent teeth due to environmental factors. The incidence of this problem varies from country to country, but it is estimated that about 5% of Americans have missing teeth, with the incidence being much higher among older adults.
The drug itself deactivates the USAG-1 (uterine sensitization-associated gene-1) protein, which suppresses tooth growth. As we reported in 2023, blocking the interaction of USAG-1 with other proteins promotes bone morphogenetic protein (BMP) signaling, which triggers the formation of new bone.
This resulted in new teeth appearing in the mouths of mice and ferrets - species that have almost the same properties of USAG-1 as humans.
„The USAG-1 protein has a high amino acid homology of 97% between different animal species, including humans, mice, and hamsters,” the researchers noted. However, it is not yet known whether testing will be conducted on eagles...
Molecular biologist and dentist Takahashi has been working on tooth regeneration since 2005 and hopes that this treatment will not only be for congenital dental diseases, but for anyone who has lost teeth, at any age.
If the therapy proves successful, within six years it will be possible to apply it to patients with permanently missing teeth.