Mongersen - Celgene Corporation

Drug Profile

Mongersen - Celgene Corporation

Alternative Names: GED-0301

Latest Information Update: 19 Apr 2018

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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

  • 15 Mar 2018 Celgene terminates a phase I trial following a recommendation from external DMC to terminate the ongoing phase III CD studies in Crohn's disease in USA, Canada, Slovakia, Hungary and Australia (PO) (NCT02367183)
  • 09 Nov 2017 Celgene terminates a phase II trial in Crohn's disease (Treatment experienced) in Italy following a recommendation from external DMC (PO) (NCT02685683)
  • 09 Nov 2017 Celgene Corporation withdraws the phase III DEFINE trial prior to enrolment based upon sponsor decision not to start trial for Crohn's disease (In adolescents, In adults,In the elderly, Treatment-experienced) in USA, Australia, Israel, South Korea, Canada, Serbia, Switzerland, Turkey, Ukraine, Russia and European Union (PO, Tablet) (NCT02974322)
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