A new medicine being tested in Japan could one day help humans grow missing teeth again, offering a possible future alternative to dentures and dental implants.

Kyoto University Hospital has launched the first human trial of an experimental drug called TRG-035. The medicine has been developed by Japanese biotech startup Toregem BioPharma and is designed to unlock what researchers describe as a hidden third set of teeth.

Humans naturally grow two sets of teeth during their lifetime: baby teeth and adult teeth. However, researchers believe the body may still contain dormant tooth buds that can potentially be reactivated.

TRG-035 works by blocking a specific protein that acts like an off-switch for tooth development. Normally, this protein stops extra teeth from forming after adult teeth have grown. By blocking it, the drug may allow the body’s natural signaling pathways to restart tooth growth.

The first safety trial included 30 adult men, each missing at least one tooth. The current Phase I trial began in late 2024 and has completed its initial 11-month tracking period. Final results are still pending.

Researchers do not expect the adult participants in this early trial to regrow teeth. Instead, the main goal is to check whether the drug is safe before testing it in people who are more likely to benefit.

The science behind the treatment was first discovered in mice. Researchers engineered mice without the specific gene linked to the tooth-blocking protein, and the animals grew extra teeth. Later tests in mice and ferrets showed that a single antibody injection could grow fully functional teeth without serious safety issues.

If the safety data is positive, the next phase will focus on children aged 2 to 7 who were born with missing teeth. The treatment will first target urgent cases, especially children missing six or more teeth from birth.

Toregem BioPharma hopes to make the treatment commercially available by 2030 if clinical trials are successful. At first, the drug will be used for children born with missing teeth. Later, the company hopes to expand it to adults who lost teeth because of decay or injury.

If successful, the drug could improve chewing ability, nutrition, overall health, and quality of life for older adults worldwide.

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