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Immune globulin 10% - Grifols

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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: 07 Jan 2025

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At a glance

  • Originator Bayer HealthCare
  • Developer Bayer HealthCare; Beth Israel Deaconess Medical Center; Grifols; Kedrion; University of Texas Southwestern Medical Center
  • Class Anti-infectives; Anti-inflammatories; Antibacterials; Antidementias; Antifibrotics; Antivirals; Eye disorder therapies; Immunoglobulins; Immunoproteins; Polyethylene glycols; Serum globulins; Skin disorder therapies; Vascular 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 COVID 2019 infections; Diabetic neuropathies
  • Phase I/II Tachycardia
  • Discontinued Multiple sclerosis

Most Recent Events

  • 30 Dec 2024 Kedrion plans a phase III trial for Chronic inflammatory demyelinating polyradiculoneuropathy (IV) in September 2025 (NCT06752356)
  • 04 Jan 2024 Immune globulin is still in phase III trial in Immunodeficiency disorders (In adolescents, In children) in Hungary, Slovakia, Italy (IV)
  • 13 Sep 2023 Grifols Biologicals in collaboration with Beth Israel Deaconess Medical Center terminate a phase II trial in Diabetic neuropathy in USA (IV, Injection) due to funding withdrawn in the midst of the COVID pandemic (NCT02915263)

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