A Kyoto biotech company, Toregem BioPharma, is preparing to move its experimental tooth regrowth drug, TRG035, into a pediatric trial in children with severe congenital tooth agenesis, after an adult Phase 1 safety trial reported no serious adverse events. The company raised $5.3 million in new funding in May 2026 to fund the next phase, and its own public timeline points to a possible commercial launch around 2030, not this year or next.
What is Toregem's tooth regrowth drug and how does it work?
TRG035 is a neutralizing antibody, not a pill you swallow at home, designed to block a protein called USAG-1 that normally keeps a person's dormant "third generation" tooth buds switched off. In animal models, blocking USAG-1 allowed new teeth to form in mice, ferrets, and dogs that were otherwise missing them, according to Toregem BioPharma's own research summary. The company, a spinoff from Kyoto University founded in 2020, calls the approach "teething medicine" in Japanese, and its stated goal is a treatment for congenital tooth agenesis, a developmental condition in which some or all permanent teeth never form.
Key stats families should know:
- Toregem BioPharma raised approximately $5.3 million (around 850 million yen) in a Pre-Series C round announced in May 2026, bringing its total funding to more than $29 million, according to Dentistry.co.uk (June 2026).
- The Phase 1 safety trial, which began at Kyoto University Hospital in October 2024, enrolled adult men missing at least one molar and reported no serious adverse events, per Toregem BioPharma's trial announcement and Dealroom.co (2026).
- Toregem has said it is preparing to test the drug in young children with severe congenital tooth agenesis, with a target commercial launch around 2030, as reported by Dentistry.co.uk and JapanTalkback (2026).
Why are children the focus of the next trial phase, not adults who lost teeth to decay?
Children are the focus because their biology still contains what the drug needs to work. Mary MacDougall, dean of dentistry at the University of British Columbia, has said the approach "may only work in children, who still have plenty of dental epithelial cells," the raw material a tooth bud needs to develop, unlike adults who lost teeth to cavities or gum disease, whose epithelial cells are typically long gone. That distinction matters for families: this is not being positioned, at least for now, as a way to regrow an adult's lost molar, but as a possible option for children born without some of their permanent teeth.
What did the adult Phase 1 trial actually show?
It showed the drug appeared safe in adults over the trial period, not that it regrew teeth. The investigator-initiated study, run out of Kyoto University Hospital with Kitano Hospital and backed by Japan's AMED research agency, was designed to test safety and dosing in adult men missing at least one molar. According to Toregem BioPharma and Dealroom.co, no serious adverse events were reported, but the company's full data readout was still pending in mid-2026. Toregem co-founder and lead researcher Katsu Takahashi, an oral surgeon who has worked on the underlying science for roughly three decades, has said simply: "The idea of growing new teeth is every dentist's dream."
Which children could this eventually help, and why do current options fall short?
The intended patients are children with congenital tooth agenesis, also called severe hypodontia, where six or more permanent teeth never develop. Because a child's jaw is still growing, options like dental implants are usually off the table until the late teens, leaving families to rely on removable dentures or space maintainers for years while a child grows. A pediatric dentist, such as Oak Mountain Pediatric Dentistry in Birmingham, is typically the first stop for a family that notices missing permanent teeth, since diagnosis and interim care come long before any future drug would be an option.
| Detail | Phase 1 (completed) | Phase 2 (planned, 2026) |
|---|---|---|
| Who was or will be enrolled | Adult men missing at least one molar | Young children with severe congenital tooth agenesis |
| Primary goal | Safety and dosing | Safety and early signs of effect in children |
| Location | Kyoto University Hospital | Kyoto University Hospital |
| Reported result | No serious adverse events reported | Not yet started, no results available |
When could this be available, and what should families do in the meantime?
Toregem's own public statements point to a possible market launch around 2030 at the earliest, and that assumes the pediatric trial and any later studies go well, which is not guaranteed. Nothing about TRG035 is available to patients today, and there is no way for a family to enroll a child outside of Toregem's own study protocol in Japan. For now, the most useful step for a parent who notices a child is missing permanent teeth, or whose baby teeth are not falling out on schedule, is a evaluation with a pediatric dentist or orthodontist who can confirm the diagnosis with an X-ray and map out interim care. Families who want to follow the pediatric imaging side of dental innovation can also read our earlier coverage of the first FDA-cleared dental MRI, a separate radiation-free technology aimed at diagnosing dental problems in children.
Frequently asked questions
Is the tooth regrowth drug available to patients now?
No. TRG035 is still experimental. Toregem BioPharma has completed a Phase 1 adult safety trial and is preparing a pediatric trial, but the company's own timeline points to a possible commercial launch around 2030, not sooner.
What condition is this drug meant to treat?
It targets congenital tooth agenesis, sometimes called severe hypodontia, a condition where a person's permanent teeth never form. Early pediatric work is focused on children with more severe cases, missing six or more teeth.
Did the adult trial prove the drug regrows teeth?
No. The Phase 1 trial was designed to test safety, not effectiveness. No serious adverse events were reported in adult participants, according to Toregem BioPharma and Dentistry.co.uk, but a full efficacy readout was still pending as of mid-2026.
Why are researchers moving to children instead of staying with adults?
Researchers, including University of British Columbia dean of dentistry Mary MacDougall, have said the underlying biology may only work in children, who still have the dental epithelial cells needed to form a tooth, cells that adults who lost teeth to decay or injury no longer have.
Updated July 2026.
