Kyoto University Hospital Completes 30-Patient Phase I Trial for Tooth Regrowth Drug TRG-035
Updated
Updated · Futura · May 25
Kyoto University Hospital Completes 30-Patient Phase I Trial for Tooth Regrowth Drug TRG-035
7 articles · Updated · Futura · May 25
An 11-month tracking window has ended in the first human safety trial of TRG-035, which enrolled 30 adult men each missing at least one tooth.
TRG-035, developed by Toregem BioPharma, blocks a protein that shuts down tooth development, aiming to reactivate dormant tooth buds through the body’s natural signaling pathways.
Researchers said actual regrowth in these adult volunteers is unlikely because Phase I is focused on safety, with final results still pending before broader testing begins.
The next phase would target children aged 2 to 7 with congenital tooth loss, a condition affecting about 1 in 1,000 people who are missing six or more teeth from birth.
Toregem is aiming for commercial launch by 2030, initially for congenital cases and later potentially for adults, a larger market in Japan where more than 90% of people over 75 lack at least one tooth.
With a tooth-regrowing drug on the horizon, is the era of the dental implant already over?
At $11,000 per tooth, will this revolutionary drug only be a solution for the wealthy?
By turning off the body's natural 'off-switch' for teeth, what unknown biological doors might we be opening?
Human Tooth Regeneration Drug TRG-035 Completes Phase I Trial: Safety Results and Next Steps Toward 2030 Market Launch
Overview
In May 2026, the Phase I clinical trial for TRG-035, a new drug developed to regrow human teeth naturally, was successfully completed. This trial, held at Kyoto University Hospital, involved 30 adult men who were missing at least one molar. TRG-035 works by blocking a protein that normally suppresses tooth growth, aiming to unlock the body’s natural ability to form new teeth. The main goal of this first trial was to check the drug’s safety and how well it is tolerated in humans. With these safety results, the drug is now ready for further studies to test if it can truly regrow teeth.