Japanese scientists are set to commence the world’s first clinical trials for a groundbreaking “tooth regrowth medicine” at Kyoto University Hospital, according to The Mainichi.

In September, the startup Toregem Biopharma will begin testing what is believed to be the first treatment capable of regrowing teeth. This innovative therapy aims to address congenital anodontia, a condition where individuals are born without some or all of their teeth. Toregem Biopharma, affiliated with Kyoto University, announced the clinical trials on Thursday and aims to bring the antibody drug to market by 2030. The company also hopes to eventually offer this treatment to individuals who lose teeth later in life.

The medicine works by targeting a specific protein that inhibits tooth growth. In animal tests involving mice, the antibody drug stimulated the development of tooth buds in the jaw, leading to the formation of new teeth.

Congenital anodontia affects an estimated 0.1% of the population, and current treatments involve implants or dentures, which do not address the root cause of the condition. Toregem’s co-founder, Katsu Takahashi, whose research underpins the drug, expressed the hope of providing a new solution. “We want to make this a third option,” Takahashi said.

Toregem Biopharma is set to start Phase 1 physician-led clinical trials to ensure the drug’s safety. The initial tests will involve 30 healthy male adults who are unlikely to grow additional teeth even if the drug proves effective.

If Phase 1 trials are successful, the company plans to proceed to Phase 2 trials in 2025. These trials will focus on gauging the drug’s effectiveness in patients aged 2 to 7 who have congenital anodontia.

By Impact Lab