Byline: Medically reviewed by Dr. Jogi Jose Chungath, Oral & Maxillofacial Surgeon and Dental Implantologist, Acer Dental Clinic, Motor City, Dubai 25+ years practising and teaching across the UK, Libya, Abu Dhabi and Dubai.
A drug designed to make humans grow new teeth is in clinical testing in Japan, and this month it cleared a regulatory checkpoint that moves it closer to trials in the patients it was built for.
In a statement dated 17 August 2026, Kyoto-based Toregem BioPharma announced that Japan’s Pharmaceuticals and Medical Devices Agency had completed its required investigation of the clinical trial notification the company submitted for an exploratory trial of TRG035, its antibody drug for congenital tooth agenesis.
According to reporting by Dentistry, the planned Phase IIa study will be open-label, non-comparative and multicentre, involving 24 children with severe congenital tooth agenesis. Institutional review board assessment is still required before recruitment begins, and no start date has been announced.
This is not approval. Completion of a notification investigation permits a trial to proceed toward starting; it is not a finding that the drug works. TRG035 remains investigational and has not been shown to regrow teeth in humans.
The mechanism. TRG035 is a humanised anti-USAG-1 antibody. USAG-1 is a protein that inhibits tooth development; blocking it is intended to activate dormant tooth buds. Japan’s Ministry of Health, Labour and Welfare granted TRG035 orphan drug designation for severe congenital hypodontia the absence of six or more permanent teeth from birth in September 2025. Toregem raised approximately USD 5.3 million in May 2026, bringing cumulative funding past USD 29 million.
Phase I, in healthy adults missing at least one tooth, concluded without serious adverse events. Phase I measures safety, not effectiveness.
Clinical perspective. “We’re watching this closely if it works, it changes dentistry,” says Dr. Jogi Jose Chungath. “But it is not a reason to delay treatment. Once a tooth is lost, the bone beneath it begins to resorb. Waiting years can turn a simple implant case into one that needs grafting first.”
No method of regrowing lost teeth is publicly available anywhere today. Dental implants remain the standard of care.
