The world’s first human trial of a drug that can regenerate teeth is set to begin in a few months, less than a year after its success in animal models. This groundbreaking development could lead to the commercial availability of the medicine as early as 2030. The trial, conducted at Kyoto University Hospital from September to August 2025, will involve 30 male participants aged 30-64 who are missing at least one molar. The intravenous treatment will be tested for its efficacy in regenerating human teeth, following successful trials in ferret and mouse models with no significant side effects.
“We want to help those suffering from tooth loss,” said lead researcher Katsu Takahashi, head of dentistry and oral surgery at Kitano Hospital. “While no treatment has provided a permanent cure, we feel people’s expectations for tooth growth are high.” After this 11-month stage, researchers will trial the drug on children aged 2-7 missing at least four teeth due to congenital deficiency, affecting 1% of people. Recruitment for this Phase IIa trial is underway.
Researchers also plan to expand trials to include those with partial edentulism, individuals missing one to five permanent teeth due to environmental factors. The incidence of tooth loss varies by country, but approximately 5% of Americans are missing teeth, with higher rates among older adults. The drug deactivates the uterine sensitization-associated gene-1 (USAG-1) protein, which suppresses tooth growth. Blocking USAG-1 promotes bone morphogenetic protein (BMP) signaling, triggering new bone generation. This development offers hope to millions affected by dental issues.
