Cx 601

Drug Profile

Cx 601

Alternative Names: Adipose-derived allogenic stem cell therapy - TiGenix; Cx601; eASC therapy - TiGenix

Latest Information Update: 27 Dec 2016

Price : $50

At a glance

  • Originator Cellerix
  • Developer La Fundacion para la Investigacion Biomedica del Hospital Universitario La Paz; 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
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

  • Preregistration Rectal fistula
  • No development reported Rectovaginal fistula

Most Recent Events

  • 17 Feb 2017 TiGenix plans a global registrational phase III trial for Renal fistulas
  • 17 Feb 2017 Decision by the EMA regarding the Marketing Authorisation Application for CX 601 in the treatment of Rectal fistula is expected in 2017
  • 17 Feb 2017 TiGenix intends to submit an application for Fast Track Designation to the US FDA
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