TOKYO: The world’s first drug capable of regenerating teeth is set to undergo human trials in September this year, marking a significant step towards revolutionizing dental care, News Atlas reported.
Less than a year after its successful implementation in animal models, the innovative drug is scheduled to start human testing in September, with potential commercial availability projected as early as 2030, according to a report by News Atlas.
The forthcoming human trials, to be conducted at Japan’s Kyoto University Hospital from September 2024 to August 2025, will involve the treatment of 30 male participants, aged 30-64, who are missing at least one molar. The intravenous administration of the drug will be assessed for its efficacy in regenerating human dentition, following its success in fostering the growth of new teeth in ferret and mouse models without significant adverse effects.
Lead researcher Katsu Takahashi, head of dentistry and oral surgery at Kitano Hospital, expressed the team’s commitment to addressing the challenges faced by people suffering from tooth loss or absence. Takahashi highlighted the high expectations surrounding tooth regeneration and emphasized the absence of a permanent cure for this prevalent dental issue.
Following the initial 11-month stage of human trials, the drug will be administered to younger patients aged between two and seven, who experience congenital tooth deficiency, affecting approximately one percent of the population. Additionally, the trial will encompass persons with partial edentulism, characterized by the absence of one to five permanent teeth due to environmental factors.
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The innovative drug functions by deactivating the uterine sensitisation-associated gene-1 (USAG-1) protein, thereby inhibiting tooth growth. By impeding the interaction between USAG-1 and other proteins, the drug facilitates bone morphogenetic protein (BMP) signaling, which triggers the generation of new bone.
