Actoxumab/bezlotoxumab

Drug Profile

Actoxumab/bezlotoxumab

Alternative Names: 3D8; Bezlotoxumab/actoxumab; CDA-1/CDA-2; CDA1; GS-CDA-1/MDX-1388; MBL-CDA1/MBL-CDB1; MDX 066; MDX-066 + MDX-1388; MDX-066/MDX-1388; MK-3415 + MK-6072; MK-3415/MK-6072; MK-3415A

Latest Information Update: 12 Nov 2016

Price : $50

At a glance

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

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

    No
  • 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

Highest Development Phases

  • Phase III Clostridium infections

Most Recent Events

  • 20 Sep 2015 Merck announces intention to submit regulatory applications in USA, European Union and Canada in 2015
  • 20 Sep 2015 Efficacy and adverse events data from the phase III MODIFY I and II trials in Clostridium infections released by Merck
  • 01 May 2015 Merck Sharp & Dohme completes the phase III MODIFY II trial in Clostridium infections in USA, Japan, Spain and Poland (IV) (NCT01513239; EudraCT2011-004994-94; JapicCTI132231)
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