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Darvadstrocel - TiGenix

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Drug Profile

Darvadstrocel - TiGenix

Alternative Names: Alofisel; Cx-601

Latest Information Update: 25 Nov 2019

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At a glance

  • Originator Cellerix
  • Developer La Fundacion para la Investigacion Biomedica del Hospital Universitario La Paz; Takeda; TiGenix
  • Class 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

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

Most Recent Events

  • 15 Oct 2019 Millennium Pharmaceuticals initiates a long term follow up phase III trial in Rectal fistula in Czech Republic and Spain (NCT04075825; EudraCT2019-000333-39)
  • 02 Sep 2019 Takeda plans a phase III trial for Crohn's Disease and Rectal fistula (Intraleisonal) in October 2019 (NCT04075825)
  • 18 May 2019 Updated efficacy and adverse events data from the phase III ADMIRE-CD trial for Rectal fistula presented at the Digestive Disease Week 2019 (DDW-2019)
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