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Human immunoglobulin intravenous
Human immunoglobulin intravenous (IVIG) provides passive immunity by delivering pooled antibodies from multiple human donors to neutralize pathogens and modulate immune responses.
Human immunoglobulin intravenous (IVIG) provides passive immunity by delivering pooled antibodies from multiple human donors to neutralize pathogens and modulate immune responses. Used for Primary immunodeficiency disorders, Secondary immunodeficiency (e.g., in hematologic malignancies or post-transplant), Autoimmune and inflammatory conditions (e.g., immune thrombocytopenia, Guillain-Barré syndrome).
At a glance
| Generic name | Human immunoglobulin intravenous |
|---|---|
| Also known as | GC5107A (IV-Globulin SN Inj. 10%) |
| Sponsor | Green Cross Corporation |
| Drug class | Immunoglobulin replacement therapy / Passive immunotherapy |
| Target | Multiple (polyclonal IgG targeting various pathogens and immune targets) |
| Modality | Small molecule |
| Therapeutic area | Immunology / Infectious Disease / Hematology |
| Phase | Phase 3 |
Mechanism of action
IVIG contains polyclonal immunoglobulins (primarily IgG) extracted from pooled human plasma that bind to pathogens, toxins, and autoimmune targets. It works through multiple mechanisms including opsonization, complement activation, Fc receptor engagement, and immune modulation via anti-inflammatory pathways. This provides immediate passive immunity and helps restore immune function in immunodeficient or dysregulated states.
Approved indications
- Primary immunodeficiency disorders
- Secondary immunodeficiency (e.g., in hematologic malignancies or post-transplant)
- Autoimmune and inflammatory conditions (e.g., immune thrombocytopenia, Guillain-Barré syndrome)
- Recurrent infections in immunocompromised patients
Common side effects
- Headache
- Fever
- Chills
- Myalgia
- Infusion site reactions
- Nausea
- Thrombosis (rare)
- Aseptic meningitis (rare)
Key clinical trials
- A Clinical Study of Neoadjuvant Treatment With TQB2102 for Injection for Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer (PHASE3)
- Monitoring of Donor-specific Antibodies After Treatment With Immunoglobulins, Plasmapheresis and Rituximab in Lung Transplantation
- Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors (PHASE1)
- A Study to Evaluate How Apitegromab Works in Subjects Who Are Less Than 2 Years Old and Have Spinal Muscular Atrophy (PHASE2)
- Rituximab for Anti-cytokine Autoantibody-Associated Diseases (PHASE1)
- Cemiplimab Plus Fianlimab for the Treatment of Locally Advanced Head and Neck Basal Cell Carcinoma Before Surgery (PHASE2)
- A Study to Investigate the Use of VH3810109 With or Without Fostemsavir (FTR) to Reduce the Size and Activity of the Viral Reservoir in People Living With HIV (PHASE1)
- Immunotherapy of Relapsed Refractory Neuroblastoma With Expanded NK Cells (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Human immunoglobulin intravenous CI brief — competitive landscape report
- Human immunoglobulin intravenous updates RSS · CI watch RSS
- Green Cross Corporation portfolio CI