Third Teeth The dated record
T4

Anti-USAG-1 antibody (TRG-035)

Toregem BioPharma / Kyoto University · whole-tooth · Human efficacy or safety, single programme

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Status

Phase I single-ascending-dose safety study in adults completed according to sponsor materials (Kitano Hospital / Kyoto University Hospital, 2024-2025); Japanese orphan drug designation for severe congenital partial anodontia (Sep 2025); Phase II in preparation with financing disclosed 19 May 2026. No peer-reviewed human safety results and no public evidence of tooth induction in a person.

What would change this assessment

An efficacy endpoint, in children, reported with its statistical plan rather than by press release.

Tier history

  • 2024-05-03 T3 First-in-human Phase I announced and registered at Kitano Hospital: single ascending dose in healthy adults. Registered human work; safety endpoint only.
  • 2026-05-19 T4 Sponsor reports Phase I dosing complete and discloses financing for Phase II. Human safety data now exists for a single programme; results not yet peer-reviewed or public in detail.

Sources on file

  1. Murashima-Suginami A, Kiso H, Tokita Y, et al. (2021). Anti-USAG-1 therapy for tooth regeneration through enhanced BMP signaling. Science Advances 7(7):eabf1798. doi:10.1126/sciadv.abf1798
  2. Kitano Hospital / Toregem BioPharma (2024). First-in-human Phase I study of TRG-035 (anti-USAG-1 antibody): trial announcement and registry record , single ascending dose, adult participants. Kitano Hospital trial announcement, 3 May 2024. https://www.kitano-hp.or.jp/english/info/20240503
  3. AMED / Toregem BioPharma (2025). TRG-035 receives Japanese orphan drug designation for severe congenital partial anodontia. AMED record, 29 September 2025. https://www.amed.go.jp/news/seika/files/000149388.pdf
  4. Toregem BioPharma (2026). Pre-Series C financing and Phase II preparation disclosure; sponsor reports Phase I dosing complete. Company disclosure, 19 May 2026. https://toregem.co.jp/en/english2025/wp-content/uploads/2026/05/Toregem_PreSeriesC_Financing_EN_Final_20260519-2.pdf

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