Gadoversetamide

Drug Profile

Gadoversetamide

Alternative Names: Gd-DTPA-BMEA; MP 1177; OptiMARK

Latest Information Update: 19 Aug 2017

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At a glance

  • Originator Mallinckrodt Medical
  • Class Contrast media; Organometallic compounds; Small molecules
  • Mechanism of Action Magnetic resonance imaging enhancers
  • 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

  • Marketed CNS disorders; Liver disorders
  • No development reported Myocardial infarction

Most Recent Events

  • 20 Jul 2017 Mallinckrodt withdraws the phase III SHERLOC trial in Kidney disorders prior to enrolment because of unavailability of the study drug in USA (IV) (NCT00811863)
  • 10 Jul 2017 Guerbet announces intention to withdraw sales of gadoversetamide in the European Union starting 26 July 2017 and to phase out in other geographies by 2019
  • 10 Mar 2017 EMA's Pharmacovigilance Risk Assessment Committee recommends suspension of gadoversetamide from the market in the European Union
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