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Darvadstrocel - TiGenix

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Drug Profile

Darvadstrocel - TiGenix

Alternative Names: Alofisel; Cx-601

Latest Information Update: 06 Jun 2025

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At a glance

  • Originator Cellerix
  • Developer La Fundacion para la Investigacion Biomedica del Hospital Universitario La Paz; Takeda; TiGenix
  • Class Mesenchymal stem cell therapies; Stem cell therapies
  • Mechanism of Action Cell replacements
  • Orphan Drug Status

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

    Yes - Rectal fistula
  • New Molecular Entity No

Highest Development Phases

  • Marketed Rectal fistula
  • No development reported Rectovaginal fistula; Ulcerative colitis

Most Recent Events

  • 25 May 2025 Takeda terminates a phase-III clinical trials in Rectal fistula (In children, In adolescents, Treatment-experienced) in Netherlands, Poland, Israel, Japan and Spain (Intralesional) (NCT04701411)
  • 12 Feb 2025 Discontinued - Phase-III for Rectal fistula (In adolescents, In children, Treatment-experienced) in Japan (Intralesional) prior to February 2025 (Takeda Pipeline, February 2025)
  • 12 Feb 2025 Discontinued - Phase-III for Rectal fistula (In adolescents, In children, Treatment-experienced) in Netherlands (Intralesional) prior to February 2025 (Takeda Pipeline, February 2025)

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