Researchers have announced that the world’s first clinical trial of a drug designed to grow teeth will begin in September at Kyoto University Hospital.
The groundbreaking study, led by a team at the Medical Research Institute Kitano Hospital in Osaka, aims to develop a drug that could treat congenital edentulism. This condition, which affects one in 1,000 people, is characterized by a birth defect where individuals have fewer teeth than normal.
The researchers hope to have the drug available for commercialization by 2030, providing a potential solution for those affected by this hereditary condition.
For those born missing six or more teeth, daily activities like eating can become challenging, and jaw development may be hindered. Currently, these patients often rely on dentures or implants as they grow older, but there is no cure available.
The clinical trial will be led by Katsu Takahashi, the head of the dentistry and oral surgery department at Kitano Hospital. The research team has focused on USAG-1, a molecule that inhibits bone-forming proteins, to develop a drug that can suppress USAG-1’s effects. This approach has already shown promise, as it has successfully generated teeth in mice and a beagle dog.
Starting in September, the clinical trial will involve healthy adult participants who will receive injections of the drug to assess its safety and determine whether it causes any health issues. The trial is expected to run until August 2025. After the drug’s safety is confirmed, the team plans to test it on children aged 2 to 7 years who are missing at least four teeth.
Researchers believe the drug could also help patients who have lost teeth due to gum disease or injuries.
Takahashi expressed hope that the drug would offer a third option for patients, in addition to traditional treatments like dentures and implants. “We are hoping that the drug will be a third option that stands out from the existing treatments,” Takahashi said.
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