{
  "dataset": "thirdteeth.com programme tracker",
  "license": "CC BY 4.0: free reuse with attribution to thirdteeth.com and the cited primary sources",
  "generated": "2026-07-28",
  "tiers": {
    "1": "In vitro / mechanism",
    "2": "Animal result",
    "3": "Small or narrow human data",
    "4": "Human efficacy or safety, single programme",
    "5": "Replicated human efficacy"
  },
  "count": 5,
  "programs": [
    {
      "id": "anti-usag-1-trg035",
      "name": "Anti-USAG-1 antibody (TRG-035)",
      "route": "whole-tooth",
      "developer": "Toregem BioPharma / Kyoto University",
      "tier": 4,
      "tierName": "Human efficacy or safety, single programme",
      "tierHistory": [
        {
          "date": "2024-05-03",
          "tier": 3,
          "note": "First-in-human Phase I announced and registered at Kitano Hospital: single ascending dose in healthy adults. Registered human work; safety endpoint only.",
          "tierName": "Small or narrow human data"
        },
        {
          "date": "2026-05-19",
          "tier": 4,
          "note": "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 Human safety data now exists for a single programme; results not yet peer-reviewed or public in detail.",
          "tierName": "Human efficacy or safety, single programme"
        }
      ],
      "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.",
      "watchlisted": true,
      "whatWouldChange": "An efficacy endpoint, in children, reported with its statistical plan rather than by press release.",
      "references": [
        "murashima-suginami-2021",
        "kitano-2024-phase1",
        "amed-2025-orphan",
        "toregem-2026-financing"
      ],
      "url": "https://thirdteeth.com/programs/anti-usag-1-trg035/"
    },
    {
      "id": "pulp-dentin-repair",
      "name": "Pulp and dentine repair (DPSC/SHED grafts, small molecules)",
      "route": "repair",
      "developer": "Multiple academic groups (Xuan et al. autologous pulp stem cell trial; Sharpe lab GSK-3 antagonist work)",
      "tier": 3,
      "tierName": "Small or narrow human data",
      "tierHistory": [
        {
          "date": "2017-01-09",
          "tier": 2,
          "note": "Tideglusib (GSK-3 antagonist) promotes reparative dentine formation in a mouse tooth-injury model (Neves et al., Scientific Reports). Animal result.",
          "tierName": "Animal result"
        },
        {
          "date": "2018-08-22",
          "tier": 3,
          "note": "Randomized trial of autologous deciduous-tooth pulp stem cell implantation in immature permanent incisors: 26 patients evaluated with 24-month imaging, regenerated pulp tissue with vessels and nerves (Xuan et al., Sci Transl Med). Narrow endpoint , inside an existing tooth.",
          "tierName": "Small or narrow human data"
        }
      ],
      "status": "This is where human data actually is: a randomized, controlled trial of autologous pulp stem cell grafts in immature permanent incisors (26 patients evaluated, 24-month imaging) reported continued root development and regenerated pulp. Tideglusib dentine repair is preclinical; cell-free scaffolds and biomimetic enamel remineralisation address surface lesions, not enamel regrowth. Clinically relevant regeneration, but categorically different from growing a whole tooth.",
      "watchlisted": false,
      "whatWouldChange": "Controlled human evidence that repair extends beyond the pulp space , true enamel regrowth rather than surface remineralisation.",
      "references": [
        "xuan-2018",
        "neves-2017"
      ],
      "url": "https://thirdteeth.com/programs/pulp-dentin-repair/"
    },
    {
      "id": "bioengineered-tooth-germ",
      "name": "Bioengineered tooth germ (organ germ transplant)",
      "route": "whole-tooth",
      "developer": "Tsuji lab lineage (Ikeda et al., RIKEN / Tokyo University of Science)",
      "tier": 2,
      "tierName": "Animal result",
      "tierHistory": [
        {
          "date": "2009-08-03",
          "tier": 2,
          "note": "A transplanted bioengineered tooth germ erupted, occluded, and responded to mechanical and pain stimuli in an adult mouse (Ikeda et al., PNAS).",
          "tierName": "Animal result"
        }
      ],
      "status": "Fully functional whole-tooth replacement demonstrated in adult mice (2009). Human cell sourcing and developmental control remain major gaps; no human protocol has been proposed.",
      "watchlisted": false,
      "whatWouldChange": "Independent replication of tooth formation in a large animal by a group with no commercial stake, or a credible human cell-sourcing plan.",
      "references": [
        "ikeda-2009"
      ],
      "url": "https://thirdteeth.com/programs/bioengineered-tooth-germ/"
    },
    {
      "id": "epithelial-organoids",
      "name": "Dental epithelial organoids",
      "route": "component",
      "developer": "Academic laboratories (e.g. Hemeryck et al., KU Leuven / UHasselt)",
      "tier": 2,
      "tierName": "Animal result",
      "tierHistory": [
        {
          "date": "2022-02-26",
          "tier": 2,
          "note": "Human-tooth epithelial organoids established with a stemness phenotype and differentiation potential, including in vivo assessment; a developmental model, not a replacement tooth.",
          "tierName": "Animal result"
        }
      ],
      "status": "Human dental epithelial organoids recreate enamel-forming developmental tissue. A powerful model of cell behaviour; the work sits at the organoid/model boundary, not at a replacement tooth.",
      "watchlisted": false,
      "whatWouldChange": "Organoid-derived enamel tissue of native thickness and orientation, integrated in a living jaw.",
      "references": [
        "hemeryck-2022"
      ],
      "url": "https://thirdteeth.com/programs/epithelial-organoids/"
    },
    {
      "id": "root-organoids",
      "name": "Tooth root organoids / whole-tooth reassociation",
      "route": "component",
      "developer": "Academic laboratories (e.g. Syed-Picard lab, University of Pittsburgh)",
      "tier": 2,
      "tierName": "Animal result",
      "tierHistory": [
        {
          "date": "2024-05-01",
          "tier": 2,
          "note": "Self-assembled tooth root organoids from postnatal human dental stem cells organize dentin-, pulp-, cementum- and ligament-like tissue; includes in vivo assessment. Eruption, crown, innervation and integration unresolved.",
          "tierName": "Animal result"
        }
      ],
      "status": "Root-like organization from human dental stem cells is encouraging. Eruption, crown formation, innervation, and periodontal integration are unresolved.",
      "watchlisted": false,
      "whatWouldChange": "Eruption, crown formation, innervation, and periodontal integration of an organoid-derived construct in an animal jaw.",
      "references": [
        "calabrese-2024"
      ],
      "url": "https://thirdteeth.com/programs/root-organoids/"
    }
  ]
}