IN THE quiet halls of Kyoto University, a revolution in dental medicine has been quietly taking shape.
Toregem Biopharma — a Japanese biotech startup founded in 2020 — is at the vanguard of an ambitious mission: to enable humans to regrow lost teeth, naturally, using their own biological “tooth buds”.
Every human begins life with a full set of baby teeth, followed by permanent teeth. Beneath the surface lie remnants of additional “tooth buds” — embryonic tooth germs that, in most people, lie dormant or gradually disappear.
Researchers at Toregem have discovered that a protein known as USAG-1 acts as a molecular brake, preventing these buds from developing into fully formed teeth.
The startup’s breakthrough came in the form of a “neutralizing antibody” — a drug designed to block USAG-1. With the protein’s inhibitory effect removed, those latent tooth buds can resume development, producing enamel, dentin, roots — a full tooth.
In experiments, this approach successfully regenerated teeth in mice, and later in animals more similar to humans, such as ferrets.
The promise is not just theoretical. Toregem has charted a concrete path toward clinical use. The company announced that its drug candidate — known as TRG035 — was officially designated as an orphan drug by Japan’s health authorities in September 2025.
Clinical trials are expected to begin soon. The startup initially aims to treat individuals with congenital tooth-deficiency — those born without certain permanent teeth. Over time, the vision expands to more common cases: adults who have lost teeth to disease, injury, or decay.
If successful, Toregem’s therapy could transform dentistry.
Currently, millions of people worldwide rely on dentures, bridges, or implants to replace missing teeth — solutions that often demand maintenance, replacements, or risk of complications. A regenerative treatment would offer a more natural, long-lasting alternative: growing one’s own teeth, complete with roots and connective tissue, using one’s own biology.
For children born with congenital tooth loss — a condition affecting tens of thousands in Japan alone, and many more globally — the impact could be profound.
Missing teeth can hinder chewing, nutrition, jaw development, and quality of life. The ability to “grow in” missing teeth could alter developmental trajectories, improve nutrition and oral health, and restore confidence.
Significant hurdles remain. While animal studies have shown promise, translating results to humans is never guaranteed.
It is also unclear exactly how many teeth can be regenerated at once, how well they will integrate with existing bone and gums, or whether there might be unintended side effects. As of now, human trials are awaited.
Moreover, bringing a drug like this to market involves not only scientific but regulatory, manufacturing, and ethical challenges — especially given that tooth buds may behave differently across individuals.
Toregem aims for a public launch around 2030, should trials go smoothly.
Toregem Biopharma is betting on a future where losing a tooth doesn’t mean settling for dentures or implants — but simply getting a prescription.
The notion that medicine might one day regenerate lost parts of ourselves — even something as fundamental as teeth — is no longer science fiction.
For now, many are watching: if this works, it may rewire the way we think about dental health forever.
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Dr. Joseph D. Lim, Ed. D., is the former Associate Dean of the College of Dentistry, University of the East; former Dean, College of Dentistry, National University; Past President and Honorary Fellow of the Asian Oral Implant Academy; Honorary Fellow of the Japan College of Oral Implantologists; Honorary Life Member of the Thai Association of Dental Implantology; and Founding Chairman of the Philippine College of Oral Implantologists. For questions on dental health, e-mail jdlim2008@gmail.com or text 0917-8591515.
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Dr. Kenneth Lester Lim, BS-MMG, DDM, MSc-OI, graduated Doctor of Dental Medicine, University of the Philippines, College of Dentistry, Manila, 2011; Bachelor of Science in Marketing Management, De la Salle University, Manila, 2002; and Master of Science (MSc.) in Oral Implantology, Goethe University, Frankfurt, Germany, 2019. He is an Associate Professor; Fellow, International Congress of Oral Implantologists; and Fellow, Philippine College of Oral Implantologists. For questions on dental health, e-mail limdentalcenter@gmail.com/PN
