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Immune globulin 10% - Grifols

Drug Profile

Immune globulin 10% - Grifols

Alternative Names: Gammaked; Gamunex; Gamunex-C; Gamunex-IGIV; IGIV; Intravenous gammaglobulin; IVIG; IVIG 10% - Kedrion; Kedrion Immunoglobulin 10%; Kedrion IVIG 10%; KIg10; TAL-05-0002

Latest Information Update: 29 May 2019

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At a glance

  • Originator Bayer HealthCare
  • Developer Bayer HealthCare; Beth Israel Deaconess Medical Center; Grifols; University of Texas Southwestern Medical Center
  • Class Anti-infectives; Anti-inflammatories; Antibacterials; Antidementias; Antivirals; Immunoglobulins; Immunoproteins; Serum globulins; Skin disorder therapies
  • Mechanism of Action Amyloid beta-protein inhibitors; 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; Idiopathic thrombocytopenic purpura; Immunodeficiency disorders
  • Phase III Myasthenia gravis
  • Phase II Diabetic neuropathies
  • Phase I/II Tachycardia
  • Discontinued Multiple sclerosis

Most Recent Events

  • 30 Apr 2019 Kedrion initiates a phase III trial in Immunodeficiency disorders (In adults, In children, In adolescents, In the elderly) in Canada, USA (IV) (NCT03961009)
  • 01 Feb 2019 Grifols Therapeutics completes a phase II trial in Myasthenia Gravis in USA, Belgium, Canada, Czech Republic, Estonia, France, Germany, Hungary, Lithuania and Poland (NCT02473965) (EudraCT2013-005099-17)
  • 24 Jun 2018 Biomarkers information updated
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