Tooth Regeneration Drug Human Trials
Toregem BioPharma secured approximately $5.3 million on June 5, 2026, to advance its experimental tooth-regeneration drug, TRG035, into Phase II clinical trials and plans to expand trials into the United States. As of June 5, 2026, early analyses from April 2026 indicate positive safety results with no significant adverse effects reported in 30 healthy adult males participating in human trials at Kyoto University Hospital. The company aims to have the treatment, which successfully regrew teeth in mice and ferrets during preclinical trials, ready for general use by 2030, with plans to include children aged 2-7 with congenital anodontia in future trials.
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June 2026 — 1 developments
Biotech Firm Secures $5.3 Million for Tooth Regeneration Drug, Plans US Trials
Toregem BioPharma has secured approximately $5.3 million to advance its experimental tooth-regeneration drug, TRG035, into Phase II clinical trials. The company has also completed a Pre-IND meeting with the U.S. FDA, indicating plans to expand clinical trials into the United States. Toregem aims to have the treatment ready for general use by 2030.
April 2026 — 1 developments
Tooth Regeneration Drug Trials Show Positive Safety Results in Adults
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
Researchers Plan Expanded Clinical Trials for Anodontia in Children Aged 2-7
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
Human trial's first stage, focusing on safety and dosage in adult males, 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
Kyoto University Hospital develops drug that regrows teeth in animals
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.
Researchers monitor participants in initial phase of human trials
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 to begin human clinical trials for 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
Drug successfully grows new teeth in mice and ferrets during animal trials
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
Study Shows USAG-1 Gene Medicine Influences 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
Dr. Takahashi's team identifies USAG-1 protein as key tooth growth inhibitor
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
Tooth Regeneration Drug Development Officially Commences
The development of a tooth regeneration drug officially commences, building upon earlier research findings.