Immune globulin 10% - Grifols

Drug Profile

Immune globulin 10% - Grifols

Alternative Names: Gammaked; Gamunex; Gamunex-C; Gamunex-IGIV; IGIV; IGIV-C; Intravenous gammaglobulin; IVIG; TAL-05-0002

Latest Information Update: 09 Mar 2018

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At a glance

  • Originator Bayer HealthCare
  • Developer Bayer HealthCare; Beth Israel Deaconess Medical Center; Grifols; Kedrion
  • Class Antidementias; Antivirals; Immunoglobulins; Immunoproteins; Serum globulins
  • Mechanism of Action Immunostimulants
  • Orphan Drug Status

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

    Yes - Chronic inflammatory demyelinating polyradiculoneuropathy
  • New Molecular Entity No

Highest Development Phases

  • Marketed Chronic inflammatory demyelinating polyradiculoneuropathy; Immune thrombocytopenic purpura; Immunodeficiency disorders
  • Phase III Myasthenia gravis
  • Phase II Diabetic neuropathies
  • Discontinued Multiple sclerosis

Most Recent Events

  • 01 Jan 2018 Grifols Therapeutics completes a phase II trial in Myasthenia gravis in USA, Canada, Lithuania, Estonia, Hungary, Czech Republic, Germany, Poland, France and Belgium (IV) (NCT02473952) (EudraCT2014-003997-18)
  • 11 Sep 2017 Phase-II clinical trials in Diabetic neuropathies in USA (IV) (NCT02915263)
  • 25 Apr 2017 Grifols Biologicals plans a phase II trial for Diabetic neuropathies in USA (NCT02915263)
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