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TRK 001

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Drug Profile

TRK 001

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

Latest Information Update: 02 Jul 2025

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At a glance

  • Originator 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
  • Preclinical Crohn's disease
  • Discontinued Autoimmune hepatitis; Liver transplant rejection

Most Recent Events

  • 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)
  • 21 Sep 2023 Phase I development is ongoing in Renal transplant rejection (Prevention) in USA (IV) (Tract Therapeutics pipeline, September 2023)

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