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TRK 001

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Drug Profile

TRK 001

Alternative Names: Autologous T regulatory cell therapy - Singulera; TRK-001

Latest Information Update: 17 Nov 2025

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At a glance

  • Originator Tract Therapeutics
  • Developer Singulera; Tract Therapeutics
  • Class T lymphocyte cell therapies
  • Mechanism of Action Regulatory T-lymphocyte replacements
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Transplant rejection
  • New Molecular Entity No

Highest Development Phases

  • Phase II Renal transplant rejection
  • No development reported Crohn's disease
  • Discontinued Autoimmune hepatitis; Liver transplant rejection

Most Recent Events

  • 28 Sep 2025 No recent reports of development identified for preclinical development in Crohn's-disease in USA (IV)
  • 13 Jun 2025 Phase-II clinical trials in Renal transplant rejection (Prevention) in Taiwan, USA (IV)(NCT06552169)
  • 13 Aug 2024 Tract Therapeutics plans a phase II RETIRE trial for Renal transplant rejection (Prevention) in the US, Taiwan (IV, Infusion) in December 2024 (NCT06552169)

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