Tooth-Regeneration Drug Advances to Patient Trials in Japan

Kyoto-based biotech startup Toregem BioPharma has announced it will begin Phase II clinical trials of its tooth-regeneration antibody, TRG035, with actual patients for the first time.

To support this step, the company raised approximately $5.3 million in a financing round announced in May 2026.

The drug targets a specific condition, but the science behind it has drawn broad attention from the dental research community.

TRG035 works by blocking a protein called USAG-1, which normally suppresses tooth development, with the goal of activating dormant tooth buds and prompting new tooth growth.

The upcoming Phase II trial will focus on people with severe congenital hypodontia — defined as being born missing six or more permanent teeth.

Phase I trials in healthy adults with at least one missing tooth concluded without any serious adverse events,

allowing the research program to move forward.

The company's target of having the treatment ready for general use by 2030 should be treated as provisional — TRG035 still needs Phase II efficacy data and further regulatory review before it could become available.

The current stage of development is also specifically focused on severe congenital hypodontia, not adult tooth loss caused by gum disease, trauma, or decay.

For patients, the key takeaway is that this research is still in early stages and years away from any potential clinical use.

Although TRG035 is being developed first for congenital hypodontia, Toregem also plans to investigate its use in acquired tooth loss, where injuries, aging, and periodontal disease cause millions of adults to lose teeth annually — and where, if the drug proves effective, it could reduce the need for dental implants.

Researchers and clinicians will be watching Phase II results closely.