A Japanese pharmaceutical startup has moved a tooth regrowth drug into human clinical trials, marking a significant step toward what could one day offer an alternative to dentures and implants. Toregem Biopharma began trials after its research team successfully grew new teeth in both mice and ferrets — animals whose dental patterns closely resemble those of humans.
At a glance
- Tooth regrowth drug: The treatment works by suppressing USAG-1, a gene that limits tooth development, using a neutralizing antibody that prompts the body to grow new teeth.
- Animal trials: Researchers first confirmed the approach in mice roughly five years before human trials began, then replicated positive results in ferrets before advancing to human testing.
- Anodontia treatment: If early trials succeed, the team plans a 2025 C.E. trial targeting children aged two to six with anodontia, a rare genetic condition causing six or more missing teeth.
Two decades in the making
Dr. Katsu Takahashi, head of the dentistry and oral surgery department at the Medical Research Institute Kitano Hospital, has been working toward this moment since graduate school. His research at Kyoto University, which he began in 2005 C.E., identified a specific gene in mice that governs tooth development.
That gene — USAG-1 — acts as a natural brake on tooth growth. When scientists developed an antibody medicine capable of blocking it, the brake was released, and new teeth grew. “The idea of growing new teeth is every dentist’s dream,” Takahashi told the Mainichi. “I was confident I’d be able to make it happen.”
How the drug works
Most people grow two sets of teeth in a lifetime. The theory behind this research is that the body retains the biological machinery to grow more — it simply needs the right signal.
By suppressing USAG-1 with a neutralizing antibody, researchers believe they can unlock that dormant capacity. In the human trials, participants receive a single injection of the drug to determine whether it can reliably trigger new tooth development. The early phase focuses on healthy adults, with a pediatric trial planned for 2025 C.E.
The pediatric trial would target children with anodontia, a rare genetic disorder in which six or more baby or adult teeth are absent entirely. For these children, current options are limited and often require waiting years before implants become feasible.
What success could mean
If the clinical trials go well, Toregem Biopharma aims to seek regulatory approval in Japan by 2030 C.E. The broader hope is not to replace existing options, but to add a third one. “We’re hoping to see a time when tooth-regrowth medicine is a third choice alongside dentures and implants,” Takahashi told the Mainichi.
Tooth loss is a genuinely global health issue. The World Health Organization estimates that oral diseases affect nearly 3.5 billion people worldwide, with severe tooth loss — often linked to decay, gum disease, or injury — reducing quality of life for hundreds of millions. A drug that regenerates natural teeth could eventually reach far beyond the rare-disease context of the initial trials.
Japan’s investment in this space reflects a broader national emphasis on biomedical research and regenerative medicine, an area in which Japanese institutions have been notably active in recent decades.
Still a long road ahead
It’s important to keep expectations grounded. Human trials are just beginning, and the path from early-phase safety testing to approved medicine typically takes many years and involves multiple rounds of review. The 2030 C.E. approval target is contingent on each trial phase delivering positive results — a far from guaranteed outcome.
There are also open questions about dosing, long-term effects, and whether the mechanism translates as cleanly in humans as it did in animal models. Researchers have not yet published peer-reviewed results from the human trial phase, and independent replication will be essential before any broad clinical use.
Even so, the science underpinning the approach is well-grounded. And for the millions of people — children with anodontia among them — who currently have no good biological option for replacing missing teeth, a drug like this could represent a meaningful advance in dental medicine.
Read more
For more on this story, see: Global News — Tooth regrowth drug enters clinical trials
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