New Drug Can ReGrow Teeth?

Imagine a world where losing a tooth is no longer a permanent issue. Instead of relying on dentures, bridges, or implants, you could simply regrow a new, natural tooth. This is the vision driving Toregem Biopharma, a cutting-edge pharmaceutical startup based in Osaka, Japan. Backed by Kyoto University, Toregem is developing a groundbreaking drug to make tooth regeneration a reality, potentially transforming dental care forever.

Tooth loss has long been a challenge for millions of people worldwide, with causes ranging from congenital conditions to decay, periodontal disease, or aging. Current treatments, such as dentures and implants, come with limitations—they can be costly, uncomfortable, and require specialized care. Toregem Biopharma aims to offer a revolutionary alternative by creating a drug that regenerates teeth naturally.

Founded in 2020, Toregem Biopharma is led by Honoka Kiso, who has a deeply personal connection to the mission. As a high school student, Kiso lost two teeth due to mandibular bone disease and required dental implants. Reflecting on her experience, she shared, “I wanted to study the cause of my illness and how to regenerate lost teeth.” Her determination laid the foundation for a company that seeks to change lives by tackling the root causes of tooth loss.

Toregem’s ultimate goal is to develop a drug that works for various cases, including congenital tooth loss (known as edentulism), damage from decay, and age-related loss. Kiso envisions a future where no one fears losing a tooth. “If they know that it is possible to regrow a lost tooth, then they won’t be afraid of unavoidable tooth loss due to tooth decay or periodontal disease,” she said. “We hope to realize a world where people can chew with their own teeth for a long time, even as they grow old.”

How Does the Drug Work?

Toregem’s groundbreaking approach is based on inhibiting a molecule called USAG-1 (Uterine Sensitization-Associated Gene-1), which naturally suppresses tooth growth. This molecule affects critical proteins responsible for bone and tooth formation. Researchers have discovered that blocking USAG-1 allows dormant “tooth buds” or “tooth embryos” to develop into fully grown teeth.

According to Dr. Katsu Takahashi, co-founder of Toregem and a professor of Oral and Maxillofacial Surgery at Kyoto University, “The idea of growing new teeth is every dentist’s dream. I’ve been working on this since I was a graduate student.” The drug, an injectable antibody therapy, has already demonstrated success in animal models, including mice, ferrets, and dogs. In one 2018 study, ferrets—a species with dental patterns similar to humans—grew new teeth after receiving the drug, with no serious side effects reported.

Clinical Trials and Timeline for Human Use

Encouraged by promising animal studies, Toregem plans to begin clinical trials on humans in 2024. The first phase will focus on healthy adult volunteers to ensure the drug’s safety. A second phase, planned for 2025, will target children aged 2 to 6 years who suffer from congenital anodontia, a rare condition where some or all permanent teeth fail to develop. These children will receive a single dose of the drug to stimulate natural tooth growth.

If the trials are successful, Toregem anticipates bringing the drug to market by 2030. This timeline represents a significant step toward addressing tooth loss for people of all ages. As Dr. Takahashi explained, “Missing teeth in a child can affect the development of their jaw bone. We hope the drug will serve as a key to solving those problems.”

Benefits Beyond Implants and Dentures

Toregem’s drug promises to offer a natural solution to tooth loss, which could vastly improve the lives of people with dental issues. The benefits include:

• Improved Quality of Life: Dentures often need frequent adjustments, especially for children whose jawbones are still developing. Implants, while effective, can be expensive and require invasive procedures. The ability to regrow natural teeth eliminates these challenges.
• Accessible Care: Regenerating teeth through a single injection simplifies treatment, making it more accessible than surgical alternatives.
• Healthier Aging: For older adults, retaining natural teeth can improve overall health, aiding in proper nutrition and reducing oral infections associated with prosthetics.

Kiso highlighted the emotional and practical significance of their work: “I have seen people undergoing regular treatments and surgeries as they try to keep a damaged or decaying tooth, even if there is little chance of success. This drug could change everything.”

Potential for Older Adults

One of the most exciting possibilities is the application of the drug for older adults. Research has revealed that humans may have dormant “buds” for a third set of teeth, similar to how reptiles can regrow teeth continuously. While these buds typically remain inactive and disappear over time, Toregem’s drug could reactivate them, enabling tooth regrowth even in aging individuals.

This innovation could alleviate the widespread fear of tooth loss later in life. “We want to create a society where people can confidently live without worrying about dental treatments for lost teeth,” said Kiso. For older adults, the implications are profound, offering improved quality of life and reduced reliance on prosthetics.

The Road Ahead: A Revolutionary Future

Toregem Biopharma’s journey is an inspiring blend of scientific innovation and personal passion. Backed by over a decade of research, including early breakthroughs in 2007 with mice that grew additional teeth, the company’s work represents a new frontier in dental medicine.

By addressing congenital, acquired, and age-related tooth loss, Toregem is not only solving a medical problem but also redefining what’s possible in healthcare. With its drug set to enter clinical trials and plans for a market release by 2030, the world is on the brink of a dental revolution.

As Dr. Takahashi aptly summarized, “Conventional tissue engineering is not suitable for tooth regeneration. Our study shows that cell-free molecular therapy is effective for a wide range of congenital tooth agenesis.” For millions of people, Toregem’s work could mean the end of living with lost teeth—and the beginning of a world where everyone can smile without fear.