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Immune globulin - Grifols

Drug Profile

Immune globulin - Grifols

Alternative Names: Flebogamma 10% DIF; Flebogamma 5% DIF; Flebogamma DIF; GamaSTAN; GamaSTAN S/D; IGSC 20% - Grifols; Immune Globulin Subcutaneous 20% Caprylate/Chromatography; Intravenous normal Human immunoglobulin – Grifols; IVIG - Grifols; Xepol; XS-28

Latest Information Update: 02 Nov 2018

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At a glance

  • Originator Grifols
  • Class Antidementias; Antivirals; Immunoglobulins; Immunoproteins; Serum globulins
  • 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 - Postpoliomyelitis syndrome
  • New Molecular Entity No

Highest Development Phases

  • Marketed Guillain-Barre syndrome; Hepatitis A; Idiopathic thrombocytopenic purpura; Immunodeficiency disorders; Measles; Rubella; Varicella zoster virus infections
  • Registered Mucocutaneous lymph node syndrome
  • Phase III Alzheimer's disease
  • Phase II/III Postpoliomyelitis syndrome

Most Recent Events

  • 24 Jan 2019 Grifols Therapeutics plans a phase III trial for Immunodeficiency disorders (In children, In adolescents, In adults, In elderly, Treatment naive, Treatment experienced) in February 2019 in USA and European Union (IV, SC) (NCT03814798)
  • 27 Oct 2018 Top-line efficacy data from the phase III AMBAR trial in Alzheimer's disease released by Grifols
  • 08 Oct 2018 The US FDA approves a new formulation of GamaSTAN® for Hepatitis A and Measles postexposure prophylaxis in USA (IM)
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