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immune globulin (human)

Trade name: Gamastan

Biologicalapproved

Approved

Jan 11, 1944

An antibody (Ab), or immunoglobulin (Ig), is a large, Y-shaped protein belonging to the immunoglobulin superfamily which is used by the immune system to identify and neutralize antigens such as bacteria and viruses, including those that cause disease. Each individual antibody recognizes one or more specific antigens, and antigens of virtually any size and chemical composition can be recognized. Antigen literally means "antibody generator", as it is the presence of an antigen that drives the formation of an antigen-specific antibody. Each of the branching chains comprising the "Y" of an antibody contains a paratope that specifically binds to one particular epitope on an antigen, allowing the two molecules to bind together with precision. Using this mechanism, antibodies can effectively "tag" the antigen for attack by cells of the immune system, or can neutralize it directly. — Wikipedia

Clinical trial activity

437 trials · 365 clinical orgs · 7 marketing orgs

Phase 1
39
Phase 2
298
Phase 3
218
Phase 4
51

Earliest trial started Nov 1, 1975 (NCT00000580)

Timeline

1940s

  1. Jan 11, 1944

    Earliest FDA Approval

  2. Jan 11, 1944

    Grifols — NDA Secondary Org

  3. Jun 1, 1944

    Harvard University — First NDA Organization

  4. Jun 1, 1944

    Harvard University — NDA Organization

1970s

  1. Jan 1, 1975

    Earliest Phase 3 Sponsor(trial)

1980s

  1. Jan 1, 1985

    Earliest Phase 2 Sponsor(trial)

  2. Feb 18, 1986

    Takeda — NDA Secondary Org

1990s

  1. Jan 1, 1996

    Earliest Phase 1 Sponsor(trial)

2000s

  1. Mar 17, 2000

    CSL Behring — NDA Secondary Org

  2. May 21, 2004

    Octapharma — NDA Secondary Org

  3. Sep 17, 2009

    Bio Products Laboratory — NDA Secondary Org

2010s

  1. Dec 19, 2012

    ADMA Biologics, Inc. — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

  • Unspecified targetOTHER

    Replacement therapy, immunomodulatory effects

  • BloodImmunity, passive

    Blood immunity, passive

Approval history

  • approvedJan 11, 1944

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No

Oral

No

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • baygam
  • bivigam
  • flebogamma
  • gamimune n 10%
  • gamimune n 5%
  • gammagard
  • gammagee
  • gammagee
  • gammar
  • gammar
  • gammar-p i.v.
  • gamulin
  • gamulin
  • gamunex
  • globulin, immune
  • globulin, immune human serum
  • globulin, immune human serum
  • human igg
  • human immunoglobulin g
  • human normal immunoglobulin
  • human normal immunoglobulin
  • human normal immunoglobulin (ivig)
  • human normal immunoglobulin (scig)
  • (−)-huperazine a
  • (−)-huperazine a
  • huperzine
  • huperzine
  • huperzine a
  • huperzine a
  • huperzine a
  • i10e
  • immu-g
  • immu-g
  • immuglobin
  • immuglobin
  • immune globulin
  • immune globulin human
  • immune globulin (human)
  • immune globulin (human)
  • immune globulin intravenous
  • immune globulin intravenous (human)
  • immune globulin subcutaneous
  • immunoglobulin g (human)
  • immunoglobulin g, human
  • intravenous immunoglobulin
  • ivig
  • ivig
  • l-huperzine a
  • l-huperzine a
  • octagam
  • ri-002
  • sandoglobulin
  • selagine
  • selagine
  • (−)-selagine
  • (−)-selagine
  • tegeline
  • venoglobulin-i
  • venoglobulin-s

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07220915Phase 3Dec 31, 2025Octapharma
NCT07299695Phase 3Dec 31, 2025University of Patras
NCT07231523Phase 3Dec 1, 2025Fudan University, Guangzhou University, Huazhong University of Science and Technology, Nanjing Medical University, People's Liberation Army of China, Sichuan University, Soochow University, Wenzhou Medical University, Xuzhou Medical University
NCT06752356Phase 3Nov 30, 2025Kedrion SpA
NCT07233213Phase 3Nov 30, 2025Government of China
NCT06980480Phase 3Nov 29, 2025Takeda
NCT07264517Phase 2Nov 3, 2025Grifols
NCT06920004Phase 3Aug 22, 2025argenx
NCT06954441Phase 3Aug 15, 2025Hospital do Coracao, On Pharma Importadora, Exportadora e Distribuidora de Medicamentos LTDA.
NCT07059000Phase 3Aug 13, 2025ICON, Kedrion SpA
NCT06962631Phase 3Jul 18, 2025Hcor Research Institute, Hospital do Coracao, On Pharma Importadora, Exportadora e Distribuidora de Medicamentos LTDA.
NCT07076446Phase 4Jul 15, 2025CSL Behring
NCT07017036Phase 3Jul 1, 2025Virchow Group
NCT06976476Phase 2May 8, 2025Memorial Sloan-Kettering Cancer Center
NCT07202078Phase 2/Phase 3 (Phase 3)May 7, 2025Monash University
NCT07202091Phase 2/Phase 3 (Phase 3)May 6, 2025Monash University
NCT07202052Phase 2/Phase 3 (Phase 3)May 6, 2025Monash University
NCT06896253Phase 2Apr 30, 2025Assistance Publique - Hôpitaux de Paris
NCT07202065Phase 2/Phase 3 (Phase 3)Apr 28, 2025Monash University
NCT07193953Phase 1Apr 15, 2025Focused Ultrasound Foundation, University of Toronto
Showing 20 of 437 trials
Page 1 / 22

Organizations

Research & Development (365)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
CSL BehringFor profit382452002
GrifolsFor profit372551999
OctapharmaFor profit272332002
BaxaltaFor profit231742002
TakedaFor profit12942020
University of TorontoAcademic/Hospital12751999
Green Cross CorporationFor profit9822009
Harvard UniversityAcademic/Hospital9632012
Bio Products LaboratoryFor profit8732000
Huazhong University of Science and TechnologyAcademic/Hospital8432013
National Institute of Allergy and Infectious Diseases (NIAID)Government8621991
Nihon Pharmaceutical Co., LtdFor profit8822008
Jiao Tong UniversityAcademic/Hospital7342013
Assistance Publique - Hôpitaux de ParisAcademic/Hospital6632018
Biotest PharmaceuticalsFor profit6632007
Fudan UniversityAcademic/Hospital6622013
National Institute of Neurological Disorders and Stroke (NINDS)Government6531990
University of ParisAcademic/Hospital6532001
Kedrion SpAFor profit5512012
Laboratoire français de Fractionnement et de BiotechnologiesFor profit5312004
365 organizations
Page 1 / 19

Marketing (7)

OrganizationOrg typeRelationshipDate
ADMA Biologics, Inc.For profitNDA2Dec 19, 2012
Bio Products LaboratoryFor profitNDA2Sep 17, 2009
CSL BehringFor profitNDA2Mar 17, 2000
GrifolsFor profitNDA2Jan 11, 1944
Harvard UniversityAcademic/HospitalNDAJun 1, 1944
OctapharmaFor profitNDA2May 21, 2004
TakedaFor profitNDA2Feb 18, 1986