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Immune globulin - GC Pharma

Drug Profile

Immune globulin - GC Pharma

Alternative Names: GC-5101B; GC5107; GC5107A; I.V.-Globulin SN inj.; IGIV-SN; IVIG 10%; IVIG-S 5%; IVIG-SN 5%

Latest Information Update: 13 Jul 2020

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At a glance

  • Originator Green Cross
  • Developer GC Pharma
  • Class Anti-infectives; Anti-inflammatories; Antibacterials; Antidementias; Antifibrotics; Antivirals; Eye disorder therapies; Immunoglobulins; Immunoproteins; 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.

  • New Molecular Entity No

Highest Development Phases

  • Marketed Agammaglobulinaemia; Guillain-Barre syndrome; Infections; Mucocutaneous lymph node syndrome
  • Preregistration Immunodeficiency disorders
  • Phase III Thrombocytopenia

Most Recent Events

  • 08 Oct 2020 GC Pharma plans a phase III trial for Immunodeficiency disorders in November 2020 (NCT04565015),
  • 30 Jul 2020 GC pharma announces intention to submit BLA to the USFDA for Immune globulin (IVIG 10%) in fourth quarter of 2020
  • 07 Jul 2020 Green Cross Corporation withdraws a phase III trial prior to enrolment for primary Immunodeficiency disorders (In children, In adolescents) (IV), due to a change in the sponsor's developmental strategy (NCT03492710)
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