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Immune Globulin (Human)
Immune Globulin (Human) is a Immunoglobulin replacement therapy Biologic drug developed by Grifols Therapeutics LLC. It is currently FDA-approved for Primary immunodeficiency disorders, Secondary immunodeficiency, Chronic inflammatory demyelinating polyneuropathy (CIDP). Also known as: GamaSTAN.
Immune Globulin (Human) provides passive immunization by supplying pooled human antibodies to enhance immune function and neutralize pathogens.
Immune Globulin (Human) provides passive immunization by supplying pooled human antibodies to enhance immune function and neutralize pathogens. Used for Primary immunodeficiency disorders, Secondary immunodeficiency, Chronic inflammatory demyelinating polyneuropathy (CIDP).
At a glance
| Generic name | Immune Globulin (Human) |
|---|---|
| Also known as | GamaSTAN |
| Sponsor | Grifols Therapeutics LLC |
| Drug class | Immunoglobulin replacement therapy |
| Target | Multiple pathogenic antigens and pathogens (non-specific) |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Mechanism of action
This product is a preparation of immunoglobulin G (IgG) antibodies derived from pooled human plasma that provides immediate, passive immunity. It works by delivering pre-formed antibodies that can bind to and neutralize pathogens, opsonize antigens for destruction, and activate complement. This is used in patients with immunodeficiency or to provide rapid immune protection in specific clinical scenarios.
Approved indications
- Primary immunodeficiency disorders
- Secondary immunodeficiency
- Chronic inflammatory demyelinating polyneuropathy (CIDP)
- Immune thrombocytopenia (ITP)
- Post-transfusion purpura
- Kawasaki disease
Common side effects
- Headache
- Fever
- Chills
- Myalgia
- Infusion site reactions
- Thrombosis
- Aseptic meningitis
Key clinical trials
- Durvalumab in Combination With Chemotherapy in Treating Patients With Advanced Solid Tumors, DURVA+ Trial (PHASE2)
- Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma (PHASE3)
- Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma (PHASE3)
- Paclitaxel and Carboplatin With or Without Bevacizumab in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer (PHASE3)
- Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial (PHASE3)
- Pegylated Liposomal Doxorubicin Hydrochloride With Atezolizumab and/or Bevacizumab in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (PHASE2, PHASE3)
- Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial (PHASE2, PHASE3)
- Cetuximab and Recombinant Interleukin-12 in Treating Patients With Squamous Cell Carcinoma of the Head and Neck That is Recurrent, Metastatic, or Cannot Be Removed by Surgery (PHASE1, PHASE2)
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:
- Immune Globulin (Human) CI brief — competitive landscape report
- Immune Globulin (Human) updates RSS · CI watch RSS
- Grifols Therapeutics LLC portfolio CI
Frequently asked questions about Immune Globulin (Human)
What is Immune Globulin (Human)?
How does Immune Globulin (Human) work?
What is Immune Globulin (Human) used for?
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Is Immune Globulin (Human) also known as anything else?
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What does Immune Globulin (Human) target?
Related
- Drug class: All Immunoglobulin replacement therapy drugs
- Target: All drugs targeting Multiple pathogenic antigens and pathogens (non-specific)
- Manufacturer: Grifols Therapeutics LLC — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Primary immunodeficiency disorders
- Indication: Drugs for Secondary immunodeficiency
- Indication: Drugs for Chronic inflammatory demyelinating polyneuropathy (CIDP)
- Also known as: GamaSTAN
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing