Mongersen - Celgene Corporation

Drug Profile

Mongersen - Celgene Corporation

Alternative Names: GED-0301

Latest Information Update: 06 Nov 2017

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At a glance

  • Originator Giuliani
  • Developer Celgene Corporation
  • Class Anti-inflammatories; Antisense oligonucleotides
  • Mechanism of Action Smad7 protein inhibitors
  • Orphan Drug Status

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

    Yes - Crohn's disease
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Crohn's disease
  • Phase II Ulcerative colitis

Most Recent Events

  • 19 Oct 2017 Celgene suspends the phase III DEFINE trial in Crohn's disease (NCT02974322; 9224950)
  • 19 Oct 2017 Celgene terminates the phase III REVOLVE trial in Crohn's disease in USA, Australia, Austria, Belgium, Bulgaria, Bosnia and Herzegovina, Canada, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Israel, Italy, South Korea, Latvia, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russia, Serbia, Slovakia, Spain, Switzerland, Turkey, Ukraine and United Kingdom following the results from interim futility analysis (NCT02596893)
  • 19 Oct 2017 Celgene terminates the phase III SUSTAIN trial in Crohn's disease in USA, Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Czech republic, Denmark, France, Germany, Greece, Hungary, Israel, Italy, South Korea, Latvia, Netherlands, Norway, Poland, Portugal, Romania, Russia, Serbia, Slovakia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom following the results from interim futility analysis (NCT02641392; 9224950)
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