Kyoto University Hospital is preparing for the first-ever human clinical trial of a drug to grow teeth. The study will pass from September this year until August 2025. The subjects were 30 men aged from 30 to 64 years old who were missing at least one molar.
After the first phase of the trial, which will last 11 months, the researchers will conduct tests on patients aged 2 to 7 years who are missing at least four teeth due to a birth defect (occurs in 1% of people).
The next stage will involve studies on patients who are missing one to five teeth due to environmental factors. Only after a thorough analysis of the results of all phases of testing will a decision be made on whether the drug will be allowed on the market.
The drug itself is administered intravenously and deactivates the USAG-1 protein, which is associated with suppression of tooth growth. Early genetic studies showed that blocking USAG-1’s interaction with other proteins stimulates new bone formation.
This idea formed the basis for the development of the drug. His tests on mice and ferrets showed good results: it was possible to grow new teeth in animals, as well as strengthen their bone tissue without side effects.
The researchers note that the USAG-1 protein in mice has 97 percent amino acid similarity to humans. This gives them hope that the effect will be the same in humans.
The developers of the drug, who have been creating it since 2005, hope that in the future the medicine can be used not only for patients who have congenital dental defects, but also for those who, for one reason or another, have lost teeth at any age.
If all stages of clinical trials go smoothly, the drug could become available on the medical market by 2030.