KYOTO: A groundbreaking drug capable of regrowing teeth is set to begin human trials in September 2024, marking a significant advancement in dental medicine. Developed by researchers at Kitano Hospital in Japan, this innovative treatment aims to regenerate teeth by targeting a protein that inhibits tooth growth. Development and Mechanism: The drug, spearheaded by molecular biologist and dentist Katsu Takahashi, deactivates the uterine sensitization-associated gene-1 (USAG-1) protein, which suppresses tooth growth. By blocking USAG-1, the drug promotes bone morphogenetic protein (BMP) signaling, triggering the generation of new bone and teeth. Takahashi has dedicated his research to tooth regeneration since 2005, aiming to assist those suffering from tooth loss or congenital deficiencies. The drug has shown success in animal models, including mice and ferrets, without significant side effects. 
In mice deficient in USAG-1, an antagonist of BMP, the trace deciduous incisors survive and erupt as excess teeth (Kyoto University/Katsu Takahashi) Clinical Trial Phases: The clinical trials will be conducted at Kyoto University Hospital, beginning with 30 males aged 30-64 who are missing at least one molar. This phase will run from September 2024 to August 2025. Subsequent trials will focus on children aged 2-7 with congenital tooth deficiency, a condition affecting about 1% of the population. A third phase will target older adults missing one to five permanent teeth due to environmental factors. 
This photo provided by Kitano Hospital shows the front teeth of a ferret that was given the medicine. It had six teeth at first, but a seventh one, pictured at center, grew in. Target Demographics: The drug has the potential to benefit various groups, including:
In mice deficient in USAG-1, an antagonist of BMP, the trace deciduous incisors survive and erupt as excess teeth (Kyoto University/Katsu Takahashi) Clinical Trial Phases: The clinical trials will be conducted at Kyoto University Hospital, beginning with 30 males aged 30-64 who are missing at least one molar. This phase will run from September 2024 to August 2025. Subsequent trials will focus on children aged 2-7 with congenital tooth deficiency, a condition affecting about 1% of the population. A third phase will target older adults missing one to five permanent teeth due to environmental factors. This photo provided by Kitano Hospital shows the front teeth of a ferret that was given the medicine. It had six teeth at first, but a seventh one, pictured at center, grew in. Target Demographics: The drug has the potential to benefit various groups, including: - Individuals with congenital tooth deficiencies, such as oligodontia, affecting 0.1% of the population.
- People who have lost teeth due to cavities, injuries, or other environmental factors. It is estimated that around 5% of Americans are missing teeth, with a higher prevalence among older adults.
2026 clinical-development update
The original report described an anticipated first-in-human programme. As of May 2026, developer Toregem BioPharma reports that TRG035—a humanised anti-USAG-1 antibody—is progressing toward Phase II clinical trials in Japan. The initial development focus is congenital tooth agenesis, not routine replacement of teeth lost to caries, periodontal disease or trauma.
How the investigational therapy is intended to work
USAG-1 inhibits signalling involved in tooth development. Neutralising this protein is intended to permit development of dormant tooth buds. The biological rationale is supported by animal research, but human efficacy, tooth morphology, eruption control, occlusion, safety and durability require clinical evaluation.
What has not been established
- It is not an approved replacement for implants, bridges or dentures.
- Clinical benefit for common acquired tooth loss has not been demonstrated.
- A projected commercial date is not a guarantee of approval or availability.
- Eligibility, dosing, adverse effects and long-term surveillance depend on trial results and regulators.
Readers should distinguish company development announcements from peer-reviewed clinical outcomes and avoid presenting the treatment as currently available.
Frequently asked questions
What is TRG035?
TRG035 is an investigational humanised antibody designed to neutralise USAG-1, a protein involved in inhibiting tooth development.
Is the tooth-regeneration drug available to dentists?
No. It remains under clinical development and is not routine dental treatment.
Who is the initial target population?
The developer’s initial focus is patients with congenital tooth agenesis.
Has it regenerated teeth in humans?
Human efficacy must be established through clinical trials; animal findings cannot be assumed to predict routine human outcomes.
Will it replace dental implants by 2030?
That cannot be concluded. Approval, indications and availability depend on safety and efficacy evidence and regulatory review.
2026 clinical-trial update: what has actually changed?
The programme is now more advanced than the original 2024 report, but it remains experimental. Toregem BioPharma reported that its domestic Phase I trial of TRG035 was completed and that the project passed an AMED stage-gate evaluation in February 2026. On 17 August 2026, the company announced completion of the PMDA investigation of the clinical-trial notification for a Phase IIa exploratory study in congenital tooth agenesis.
| Milestone | What it establishes | What it does not establish |
|---|---|---|
| Animal studies | Biological plausibility of anti-USAG-1 therapy | Human efficacy or long-term human safety |
| Phase I completion | Early safety/tolerability development milestone | That a functional tooth can be regenerated in people |
| Phase IIa CTN review | Regulatory progress toward exploratory efficacy study | Approval, routine availability or efficacy |
Who is the first intended population?
The immediate development focus is congenital tooth agenesis, not routine replacement of adult teeth lost to caries, periodontal disease or trauma. Broader use would require separate clinical evidence and regulatory review.
Clinical reality for dentists and patients
- TRG035 is not an approved dental treatment.
- No peer-reviewed human efficacy evidence currently proves predictable functional tooth regeneration.
- Patients should not postpone established care for missing teeth while waiting for a speculative future therapy.
- Online supplements, rinses and topical products claiming to block USAG-1 are not equivalent to the investigational antibody.
References and live-status sources
- Toregem BioPharma: AMED stage-gate announcement, February 2026
- Toregem BioPharma: Phase IIa clinical-trial notification update, August 2026
- Murashima-Suginami et al. Anti-USAG-1 therapy for tooth regeneration, Science Advances
Evidence status reviewed 23 August 2026. This is a living research update, not a treatment recommendation.
Related research: Bio-Engineered Teeth Replacement Comes Closer to Reality.
