Clinical trials on teeth-growing medicine to start in humans in September

TOKYO – Clinical trials on a medicine to grow missing teeth will be launched in September, according to a team led by Kitano Hospital in Osaka and Kyoto University Hospital in Kyoto.

The medicine is designed to treat dental agenesis, a condition in which people lack teeth from birth.

The team will administer the medicine to 30 healthy men who have lost some teeth to confirm the medicine’s safety, before testing on young patients ages 2 to 7. They aim to put the medicine on the market by around 2030. If successful, this will be the world’s first medicine to grow new teeth, the team said.

In Japan, about 120,000 people are believed to have genetic agenesis, which causes many teeth to be missing. If the condition is not treated, it could affect the development of the jaw and other body parts. This means children must have their dentures remade several times as they mature, and that once they reach adulthood they may have to have artificial teeth fixed directly to their jaw.

In experiments on mice, the team found a protein that limits teeth growth. They created an antibody to block the protein and administered it to mice and dogs with dental agenesis, who then grew teeth. The teeth are believed to have grown from the tissues needed for tooth development, which had stopped growing due to the protein.

In the clinical trials, the team will administer the medicine or a placebo intravenously to men ages 30 to 64 who lost some teeth due to cavities or other reasons and monitor for any adverse effects for a year. If the medicine is found to be safe, the team will conduct clinical trials around 2026 on about 50 children who lack four or more teeth to verify effectiveness.

The treatment is expected to cost around ¥1.5 million. The team will continue its research with an eye toward treating people who have lost their teeth due to cavities or other reasons.

Katsu Takahashi, head of dental and oral surgery at Kitano Hospital, said, “We want to keep pushing the research and create a third option after dentures and dental implants.”