Tooth Regeneration Drug Human Trials

Developing StoryLast updated MAY 21
SUMMARY

Early analyses from April 2026 indicate positive safety results for the tooth regeneration drug TRG-035 in 30 healthy adult males participating in human trials at Kyoto University Hospital. As of April 2026: No significant adverse effects have been reported, and researchers are hopeful for a potential drug release around 2030. The trials, which began in September 2024, are planned to expand to include children aged 2-7 with congenital anodontia. The drug, a humanized anti-USAG-1 antibody, previously regrew teeth in mice and ferrets during preclinical trials.

Timeline

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Timeline of developments

April 2026 1 developments

  1. Early analyses from April 2026 indicate positive safety results for the tooth regeneration drug TRG-…

    Early analyses from April 2026 indicate positive safety results for the tooth regeneration drug TRG-035, with no significant adverse effects reported in 30 healthy adult males participating in human trials at Kyoto University Hospital. Researchers remain hopeful for a potential drug release around 2030, pending the outcomes of ongoing and future trials.

November 2025 1 developments

  1. 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

January 2025 2 developments

  1. 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

  1. 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

  1. 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

  1. 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

January 2005 1 developments