FCR 001

Drug Profile

FCR 001

Alternative Names: Facilitating Cell Therapy - Novartis/Regenerex; FCR001; FCRx - Novartis/Regenerex; Haematopoietic stem cell therapies - Novartis/Regenerex

Latest Information Update: 10 Sep 2017

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At a glance

  • Originator Regenerex LLC
  • Developer Novartis; Regenerex LLC; University of Louisville
  • Class Stem cell therapies
  • Mechanism of Action Cell replacements; Immunomodulators
  • Orphan Drug Status

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

  • New Molecular Entity No

Highest Development Phases

  • Discontinued Renal transplant rejection

Most Recent Events

  • 27 Jan 2017 Discontinued - Phase-II for Renal transplant rejection (Prevention) in USA (IV) (Novartis 20-F filed in 2017)
  • 14 Jul 2016 FCR 001 is still in phase II trials for Renal transplant rejection in USA (IV, Infusion) (NCT00497926)
  • 20 Jun 2014 Novartis announces its commitment to advancing its cell therapy portfolio, including the FCRx platform
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