For most people, losing a permanent tooth means relying on a filling, crown, bridge, denture or dental implant. But Japanese researchers are exploring a very different possibility: making the human body grow new teeth naturally.
Toregem BioPharma, a biotechnology company spun out of Kyoto University, is developing an experimental antibody drug called TRG035. The treatment is designed to remove a biological barrier that normally prevents certain tooth-development pathways from becoming active.
The company has recently raised US$5.3 million to support its next clinical study, bringing its total funding, including grants and subsidies, to more than US$29 million.
The next major step is a Phase II clinical trial involving people with severe congenital hypodontia, a condition in which a person is born without several permanent teeth.
The Science Behind Tooth Regeneration
Unlike many animals, humans normally develop two generations of teeth: baby teeth and permanent adult teeth. However, scientists have long been interested in whether humans may retain biological structures capable of supporting another generation.
This idea is sometimes described as the possibility of a “third dentition.”
The research behind TRG035 focuses on a protein called USAG-1. Scientists believe USAG-1 acts as a brake on tooth development. In simple terms, it can interfere with signals that are important for the formation of teeth.
TRG035 is an antibody designed to block USAG-1.
The hope is that by removing this biological brake, dormant tooth-development pathways could become active and potentially encourage the formation of new teeth.
This is very different from replacing a missing tooth with an artificial implant. Instead of putting something inside the mouth, researchers are investigating whether the body itself could be encouraged to create a biological replacement.
Why the Next Trial Matters
The planned Phase II study is particularly important because it will focus on people with severe congenital hypodontia.
Toregem BioPharma defines this condition as the absence of six or more permanent teeth.
For children born without multiple permanent teeth, treatment can be challenging. Dental implants are generally not suitable until the jaw has finished growing. As a result, some young patients may need removable dentures or other dental solutions for several years.
Missing teeth can affect more than appearance. They can influence chewing, speech and nutrition, while also affecting confidence and overall quality of life.
A treatment that could eventually stimulate natural tooth formation could therefore offer a completely different approach for some patients.
However, it is important to emphasize that TRG035 is still an experimental treatment. The company has not yet demonstrated that the drug can reliably regrow fully functional teeth in humans.
What Happened in the First Human Trial?
Before moving toward patients with the target condition, researchers conducted a Phase I clinical trial in healthy adults who had at least one missing tooth.
According to Toregem BioPharma, the Phase I study was completed without serious adverse events.
That is an important safety milestone, but it should not be confused with proof that the treatment works.
Early-stage clinical trials are often designed primarily to examine safety, tolerability and appropriate dosing. Demonstrating that a drug can safely interact with its biological target is only one part of the journey.
The upcoming Phase II study is therefore potentially more informative about whether this approach can produce meaningful biological effects in people with a tooth-development disorder.
From Rare Condition to Common Tooth Loss?
The long-term vision is even more ambitious.
Researchers hope that tooth-regeneration technology could eventually help people who lose teeth because of decay, injury, gum disease or aging.
That could potentially change the future of dentistry.
Today, dental implants are among the major options for permanently replacing missing teeth. Although implants can provide excellent results, they are artificial replacements and require surgical procedures.
A successful tooth-regeneration treatment could theoretically allow the body to produce a biological tooth instead.
But that future is still far away.
A congenital condition such as severe hypodontia provides a logical starting point because the underlying problem is connected to tooth development. Using the same technology to regenerate teeth that were lost later in life could involve additional biological challenges.
Researchers would need to determine whether the treatment can reliably initiate tooth formation, control where the tooth develops, guide its size and shape, and ensure that the new tooth connects properly with surrounding bone and tissues.
A Potential New Era for Dentistry
The idea of regenerating human teeth may sound like science fiction, but research into the biological mechanisms controlling tooth development has been progressing for years.
TRG035 represents one attempt to translate that research into a medical treatment.
The key scientific concept is surprisingly simple: instead of replacing a missing tooth, researchers want to understand whether the body's own tooth-building machinery can be switched back on.
If successful, the implications could extend far beyond one rare dental condition.
Imagine a future in which losing a tooth does not automatically mean replacing it with an artificial structure. Instead, a carefully designed treatment could potentially activate the body's natural regenerative abilities.
That possibility is one reason tooth-regeneration research has attracted so much attention.
But There Is Still a Long Road Ahead
It is important not to describe TRG035 as a proven “tooth-growing drug.”
The treatment remains experimental, and there is currently no established evidence that it can regenerate complete, functional teeth in humans.
The upcoming clinical research will need to answer crucial questions about effectiveness, safety, dosage and long-term outcomes.
Even if the Phase II trial produces encouraging results, larger clinical studies would likely be needed before regulators could consider widespread approval.
Still, the progress represents an intriguing shift in dental research.
For centuries, dentistry has largely focused on repairing, replacing and protecting teeth. Regenerative dentistry asks a fundamentally different question:
What if we could make the body grow them again?
TRG035 may not yet provide that answer. But as researchers move from laboratory studies toward clinical testing, the possibility of biological tooth regeneration is becoming a subject that can be investigated in patients—not just imagined in the laboratory.
And if future trials prove successful, the dentist's chair of tomorrow could look very different from the one we know today.

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