A Drug That Could One Day Grow New Teeth Moves Closer to Human Testing

For most of dental history, a missing tooth has meant one outcome: an artificial replacement. A small Japanese biotech company called Toregem BioPharma, a spinout from Kyoto University, is working to change that. In May and June 2026, the company announced it had raised approximately $5.3 million in new financing to support a Phase II clinical trial of its experimental antibody drug, TRG035, bringing its total funding — including grants and government subsidies — to more than $29 million.

The science behind the drug centers on a protein called USAG-1, which appears to actively suppress a set of dormant tooth buds that humans carry but never use.

The underlying idea is that humans carry the genetic blueprint for a third set of teeth — structures called tooth buds that typically degenerate after permanent teeth come in — and researchers identified a protein called USAG-1 that actively suppresses those buds from developing.

TRG035 works as an antibody that blocks USAG-1, with the goal of letting those dormant buds activate and produce new teeth.

Phase I trials in healthy adults with at least one missing tooth were completed without serious adverse events.

The trials now moving forward specifically target severe congenital hypodontia — a rare genetic condition in which six or more permanent teeth never develop at all — and the Phase II trial is designed to enroll children between ages 2 and 12 with this diagnosis.

For these young patients, the condition can affect chewing, speech, and facial development, and currently the only available solutions are removable dentures or, once jaw growth is complete, implants.

In a separate update from July 2026, Toregem also announced it had been selected for two Kyoto overseas expansion support programs, which the company said would help it build international research partnerships and licensing activity around TRG035.

It is important to keep expectations grounded.

TRG035 still needs Phase II efficacy data, further regulatory review, and approval before it could become available.

Approval for adults who lost teeth to decay or trauma remains a separate program that has not yet begun, and it comes with open scientific questions the animal experiments did not fully answer.

Even in the most optimistic scenario,

the research team plans to have the medicine ready for general use in 2030 at the earliest.

Still, for patients — and for dentistry as a field — the idea of treating tooth loss with biology rather than prosthetics represents a meaningful shift in what may eventually be possible.