Tooth Regeneration Drug Human Trials
Japanese researchers, led by Dr. Katsu Takahashi and Toregem Biopharma, have initiated human clinical trials for a groundbreaking tooth regeneration drug, TRG-035. The drug works by inhibiting the USAG-1 protein, which naturally suppresses tooth growth, thereby reactivating dormant tooth buds. Phase 1 trials, which began in October 2024 at Kyoto University Hospital, are currently evaluating the safety and optimal dosage in adult males. The project aims to expand trials to children with congenital tooth deficiencies and eventually to a wider population, with a goal for commercial availability by 2030.
Timeline
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November 2025 — 1 developments
Researchers announce plans to expand the clinical trials to include children aged 2-7 who suffer fro…
Researchers announce plans to expand the clinical trials to include children aged 2-7 who suffer from congenital anodontia, following the successful completion of the initial adult safety trials.
August 2025 — 1 developments
The first stage of the human trial, focusing on safety and dosage in adult males, is expected to conclude.
The first stage of the human trial, focusing on safety and dosage in adult males, is expected to conclude.
January 2025 — 2 developments
The tooth regeneration drug is identified as a humanized anti-USAG-1 antibody developed at Kyoto Uni…
The tooth regeneration drug is identified as a humanized anti-USAG-1 antibody developed at Kyoto University Hospital in Japan, which successfully regrew teeth in mice and ferrets during preclinical trials.
The initial phase of human trials continues, with researchers diligently monitoring participants for any adverse effects and gathering data on appropriate dosing.
The initial phase of human trials continues, with researchers diligently monitoring participants for any adverse effects and gathering data on appropriate dosing.
May 2024 — 1 developments
Toregem Biopharma and Kyoto University Hospital publicly announce their plans to begin human clinical trials for the tooth regeneration drug in September 2024.
Toregem Biopharma and Kyoto University Hospital publicly announce their plans to begin human clinical trials for the tooth regeneration drug in September 2024.
March 2024 — 1 developments
Further successful animal trials confirm the drug's ability to grow new teeth in mice and ferrets without significant adverse effects, paving the way for human studies.
Further successful animal trials confirm the drug's ability to grow new teeth in mice and ferrets without significant adverse effects, paving the way for human studies.
March 2021 — 1 developments
A pivotal study is published, demonstrating that medicine targeting the USAG-1 gene can effectively influence tooth growth in animal models.
A pivotal study is published, demonstrating that medicine targeting the USAG-1 gene can effectively influence tooth growth in animal models.
January 2018 — 1 developments
Researchers, under Dr.
Researchers, under Dr. Takahashi's leadership, identify the USAG-1 protein as a crucial inhibitor of tooth growth, marking a significant breakthrough in the drug's development.
January 2005 — 1 developments
The development of a tooth regeneration drug officially commences, building upon earlier research findings.
The development of a tooth regeneration drug officially commences, building upon earlier research findings.