Kyoto University Hospital scientists begin Phase 1 human trials for tooth regrowth drug
Updated
Updated · The Economic Times · May 2
Kyoto University Hospital scientists begin Phase 1 human trials for tooth regrowth drug
8 articles · Updated · The Economic Times · May 2
The Japan trial started in late 2024, enrolling healthy men aged 30 to 64 with at least one missing rear tooth and running until August 2025.
Researchers are giving a single intravenous anti-USAG-1 antibody dose to assess safety, dosage and early efficacy; preliminary April 2026 analysis reportedly found no significant adverse effects.
The drug aims to unblock dormant third-generation tooth buds, after animal studies in mice, ferrets and dogs regrew teeth, with future trials planned for children with congenital anodontia.
If this drug can regrow teeth, could it unlock the potential to regenerate other human body parts?
By reactivating tooth growth, are scientists risking unforeseen long-term health consequences like cancer?
At $11,000 per tooth, will this dental miracle create a new form of health inequality?
Breaking the Tooth Growth Brake: TRG-035’s Journey from Lab to Human Trials in Dental Regeneration
Overview
In late 2024, researchers began Phase 1 human trials of TRG-035 at Kyoto University Hospital to test its safety and dosage in adults missing teeth. TRG-035 works by neutralizing the USAG-1 protein, which normally blocks a key tooth growth pathway, allowing dormant tooth buds to develop into new teeth. Preclinical studies in mice showed promising results, leading to these first human tests. If successful, pediatric trials will follow, aiming for clinical availability by 2030. This breakthrough could disrupt the $4.6 billion dental implant market and reduce the need for invasive procedures, offering a natural solution to tooth loss.