Bezlotoxumab

Drug Profile

Bezlotoxumab

Alternative Names: CDB1; Clostridium difficile toxin B monoclonal antibody; MBL-CDB1; MDX-1388; MK 6072; Zinplava

Latest Information Update: 10 Sep 2017

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At a glance

  • Originator Medarex; University of Massachusetts Medical School
  • Developer Merck & Co
  • Class Antidiarrhoeals; Monoclonal antibodies
  • Mechanism of Action Botulinum toxin inhibitors
  • Orphan Drug Status

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

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Registered Clostridium infections

Most Recent Events

  • 12 Jun 2017 Merck Sharp & Dohme plans the MODIFY III phase III trial for Clostridium infections (Prevention, In children, In adolescents) (NCT03182907)
  • 22 Apr 2017 Pooled efficacy data from the phase III MODIFY trials in Clostridium infections presented at the 27th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID-2017)
  • 22 Nov 2016 Committee for Medicinal Products for Human Use (CHMP) of EMA recommends approval of bezlotoxumab for Clostridium infections (Prevention of relapse) in European Union
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