Third Teeth The evidence record

Bibliography

Sources & bibliography

Every tier, ledger entry, and pass resolves to one of these references. Claims cite an entry in this list rather than inline links, so provenance can be checked in one place.

  1. 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
  2. Asthana G, Tamuli R, Manglani S, et al. (2026). Comparative Evaluation of Platelet-Rich Fibrin and Mineral Trioxide Aggregate in the Direct Pulp Capping of Carious Exposures: A Randomized Clinical Trial. Cureus 18(5):e108203. doi:10.7759/cureus.108203
  3. Birjandi AA, Sharpe PT (2025). The Secretome of the Inductive Tooth Germ Exhibits Signals Required for Tooth Development. Bioengineering 12(2):96. doi:10.3390/bioengineering12020096
  4. Birjandi AA, Sharpe PT (2026). Correction: The Secretome of the Inductive Tooth Germ Exhibits Signals Required for Tooth Development. Bioengineering 13(2):202. doi:10.3390/bioengineering13020202
  5. Calabrese TC, Rothermund K, Gabe CM, et al. (2024). Self-assembly of tooth root organoid from postnatal human dental stem cells. Tissue Engineering Part A 30(9-10):404-414. doi:10.1089/ten.TEA.2023.0219
  6. Calabrese TC, Rothermund K, Syed FNP, et al. (2026). Effects of size scaling on cellular dynamics and tissue patterning in tooth root organoids. Frontiers in Bioengineering and Biotechnology 14:1801110. doi:10.3389/fbioe.2026.1801110
  7. Hasan A, Chuvilin A, Van Teijlingen A, et al. (2025). Biomimetic supramolecular protein matrix restores structure and properties of human dental enamel. Nature Communications 16:9434. doi:10.1038/s41467-025-64982-y
  8. Hashim NT, Gismalla BG, Ahmed A, et al. (2026). USAG-1/SOSTDC1 as a Candidate Target for Periodontal Regeneration: Biological Rationale, Knowledge Gaps, and Future Directions. Molecules 31(19):3389. doi:10.3390/molecules31193389
  9. Hemeryck L, Hermans F, Chappell J, et al. (2022). Organoids from human tooth showing epithelial stemness phenotype and differentiation potential. Cellular and Molecular Life Sciences 79(3):153. doi:10.1007/s00018-022-04183-8
  10. Ikeda E, Morita R, Nakao K, et al. (2009). Fully functional bioengineered tooth replacement as an organ replacement therapy. Proceedings of the National Academy of Sciences 106(32):13475-13480. doi:10.1073/pnas.0902944106
  11. Kim EJ, Kim HY, Lee S, et al. (2025). Prespecified dental mesenchymal cells for the making of a tooth. International Journal of Oral Science 17:67. doi:10.1038/s41368-025-00391-7
  12. 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
  13. Mhmod MH, Hassanien AS, Abu-Seida AM, EL Ashry SH, Nagy MM, Fahmy AM (2025). Pulp response following direct pulp capping with Tideglusib and mineral trioxide aggregate: an animal study. BMC Oral Health 25(1):1218. doi:10.1186/s12903-025-06546-6
  14. Moradi Z, Karimi M, Kolahdouz S, et al. (2026). USAG-1 in tooth regeneration: a review of BMP and Wnt signaling, gingival single-cell expression, and the TRG-035 clinical timeline. Clinical and Experimental Dental Research 12(1):e70301. doi:10.1002/cre2.70301
  15. Mubeen S, He Y, Gruenhagen N, Satoskar S, Streelman JT (2026). Cellular basis of accelerated whole-tooth regeneration. eLife 15:RP110584. doi:10.7554/elife.110584
  16. 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
  17. Murashima-Suginami A, Ishimori T, Sawada T, Takamine A, Kiso H, Ohshima H, et al. (2026). Imaging biomarkers as surrogate endpoints for clinical trials on permanent tooth regeneration in congenital tooth agenesis. Journal of Oral Biosciences 68(3):100775. doi:10.1016/j.job.2026.100775
  18. Nakashima K, Tanaka J, Matsuno E, et al. (2026). Development of a high-efficiency induction system for embryonic oral epithelium from human pluripotent stem cells. Stem Cell Reports 21(3):103779. doi:10.1016/j.stemcr.2025.102781
  19. Neves VCM, Babb R, Chandrasekaran D, Sharpe PT (2017). Promotion of natural tooth repair by small molecule GSK3 antagonists. Scientific Reports 7:39654. doi:10.1038/srep39654
  20. Patni AP, Mout R, Alghadeer A, et al. (2026). Soluble Notch agonist enables human ameloblast maturation and enamel-like tissue formation for tooth regeneration. International Journal of Oral Science 18:67. doi:10.1038/s41368-026-00429-4
  21. Toregem BioPharma (2025). Notification of receipt of response regarding Pre-IND meeting with the US FDA. Company disclosure, 27 November 2025. https://toregem.co.jp/en/archives/8456
  22. 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
  23. Toregem BioPharma (2026). Announcement regarding the new executive leadership structure. Company disclosure, 28 August 2026. https://toregem.co.jp/en/archives/10477
  24. Toregem BioPharma (2026). Announcement for Completion of the PMDA Investigation of CTN (Clinical Trial Notification) for TRG035 Phase IIa Trial. Company disclosure, 17 August 2026. https://toregem.co.jp/en/archives/10459
  25. Xuan K, Li B, Guo H, et al. (2018). Deciduous autologous tooth stem cells regenerate dental pulp after implantation into injured teeth. Science Translational Medicine 10(455):eaaf3227. doi:10.1126/scitranslmed.aaf3227
  26. Yang F, Zhu X, Zhu X, Tan X, Wang J, Xie F (2026). Histologic Study of a Human Immature Permanent Premolar with Chronic Apical Periodontitis after Regenerative Endodontic Procedures. Journal of Endodontics 52(8):1359-1366. doi:10.1016/j.joen.2026.04.005
  27. Zhang Z, Hu H, Xu Z, et al. (2024). A chemically defined culture for tooth reconstitution. Advanced Science 12(3):e2404345. doi:10.1002/advs.202404345
  28. Zhang W, Yelick PC (2025). In vivo bioengineered tooth formation using decellularized tooth bud extracellular matrix scaffolds. Stem Cells Translational Medicine 14(2):szae076. doi:10.1093/stcltm/szae076