Drugs / Immune Globulin Intravenous (Human)
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Immune Globulin Intravenous (Human)

Protein / enzyme biologic

Developed for
immunodeficiency disease · chronic inflammatory demyelinating polyradiculoneuropathy · common variable immunodeficiency · polyneuropathy, inflammatory demyelinating, chronic · COVID-19 · autoimmune thrombocytopenic purpura · Alzheimer disease · leukemia
+134 more · myasthenia gravis · acquired immunodeficiency · primary thrombocytopenia · autoimmune thrombocytopenia · dermatomyositis · Guillain-Barre syndrome · idiopathic pulmonary fibrosis · inborn error of immunity · multifocal motor neuropathy · neuropathy, painful · neuropathy, small fiber · pregnancy loss, recurrent, 4 · selective IgG immunodeficiency · Wiskott-Aldrich syndrome · B cell deficiency · bronchiectasis · bronchopulmonary dysplasia · Bruton-type agammaglobulinemia · chronic obstructive pulmonary disease · chronic renal failure syndrome · cognitive impairment with or without cerebellar ataxia · demyelinating polyneuropathy · diabetes mellitus · diabetic neuropathy · diffuse cutaneous systemic sclerosis · dysgammaglobulinemia · generalized myasthenia gravis · hyper-IgM syndrome · immune-mediated necrotizing myopathy · infectious disease · Kawasaki disease · myelodysplastic syndrome · pediatric acute-onset neuropsychiatric syndrome · postpoliomyelitis syndrome · relapsing-remitting multiple sclerosis · AChR+ myasthenia gravis · acute myocardial infarction · agammaglobulinemia · amyotrophic lateral sclerosis · anemia, nonspherocytic hemolytic · anti-HLA hyperimmunization · antisynthetase syndrome · asthma · atrioventricular block · autism · autoimmune encephalitis · autoimmune neuropathy · autosomal agammaglobulinemia · B-cell chronic lymphocytic leukemia · B-cell neoplasm · biliary atresia · BK-virus nephropathy · cerebellar degeneration · colorectal cancer · congenital heart block · coronary aneurysm · diffuse scleroderma · end stage renal failure · epilepsy · fetal and neonatal alloimmune thrombocytopenia · heart failure · hereditary inclusion-body myopathy · hypersensitivity reaction disease · hypophosphatasia · idiopathic nephrotic syndrome · idiopathic small fibers neuropathy · immunoglobulin A vasculitis · inclusion body myositis · intracerebral hemorrhage · ischemic stroke · kidney failure · long COVID-19 · macular degeneration · male infertility · malignant urinary system neoplasm · melanoma · motor neuron disorder · multiple sclerosis · multiple system atrophy · myelodysplastic/myeloproliferative disease · myeloproliferative neoplasm · neuromyelitis optica · neuromyelitis optica spectrum disorder with anti-AQP4 antibodies · non-small cell lung carcinoma · obsessive-compulsive disorder · paraneoplastic neurologic syndrome · pemphigus · pemphigus vulgaris · peripheral neuropathy · peritonitis · plasma cell neoplasm · pneumonia · polyneuropathy · polyomavirus infectious disease · post-bacterial disorder · postural orthostatic tachycardia syndrome · Rasmussen subacute encephalitis · schizophrenia · selective IgG subclass deficiency · severe combined immunodeficiency · sickle cell disease · solar urticaria · staphylococcal infection · Stevens-Johnson syndrome · stiff-person syndrome · streptococcal infection · Sydenham chorea · systemic sclerosis · thrombocytopenia due to immune destruction · transverse myelitis · tropical spastic paraparesis · Unverricht-Lundborg syndrome · anti-NMDA receptor encephalitis · autoimmune autonomic ganglionopathy · autoimmune epilepsy · bullous pemphigoid · cardiomyopathy · complex regional pain syndrome type 1 · corneal neovascularization · COVID-19–associated multisystem inflammatory syndrome in children · cutaneous lupus erythematosus · fournier gangrene · gas gangrene · habitual spontaneous abortion · infectious disease with sepsis · Japanese encephalitis · necrotizing fasciitis · necrotizing soft tissue infection · Parvoviridae infectious disease · psychotic disorder · respiratory infections, recurrent, and failure to thrive with or without diarrhea · swine influenza · transplant rejection · uveitis
Investigated by
CSL Behring · Octapharma · Baxalta now part of Shire · Grifols Therapeutics LLC · Takeda · Grifols Biologicals, LLC
+205 more · Nihon Pharmaceutical Co., Ltd · Bio Products Laboratory · Takeda Development Center Americas, Inc. · Monash University · National Institute of Neurological Disorders and Stroke (NINDS) · University of Alabama at Birmingham · Assistance Publique - Hôpitaux de Paris · Biopharma Plasma LLC · Grifols, S.A. · Kedrion S.p.A. · NYU Langone Health · Prothya Biosolutions · University Health Network, Toronto · Assiut University · Astellas Pharma Inc · Baxalta Innovations GmbH, now part of Shire · Beth Israel Deaconess Medical Center · Green Cross Corporation · International Peace Maternity and Child Health Hospital · LFB · Mayo Clinic · National Cancer Institute (NCI) · National Center for Research Resources (NCRR) · National Heart, Lung, and Blood Institute (NHLBI) · National Institute of Mental Health (NIMH) · National Institutes of Health (NIH) · Oslo University Hospital · Ottawa Hospital Research Institute · Rochester General Hospital · Sutter Health · ADMA Biologics, Inc. · ASIS Corporation · Academic Medical Center - University of Amsterdam · Ain Shams University · Ajou University School of Medicine · Al Mouwasat Hospital · Al-Assad University Hospital · Albert Einstein College of Medicine · Alder Hey Children's NHS Foundation Trust · Alexion Pharmaceuticals, Inc. · Alzheimer's Disease Cooperative Study (ADCS) · Amson Vaccine and Pharma (Pvt) Limited · Anhui Provincial Hospital · Annexon, Inc. · Argyrios Tzouvelekis · Association ASLUMARE · Atlantic Research Group · Aventis Pharmaceuticals · Azidus Brasil · Azienda Ospedaliera Universitaria Integrata Verona · Azienda Socio Sanitaria Territoriale di Mantova · Barts & The London NHS Trust · Barts and the London School of Medicine and Dentistry · Baxalta Innovations GmbH, now part of Takeda · Baxter BioScience · Benesis Corporation · Birmingham Women's and Children's NHS Foundation Trust · Brigham and Women's Hospital · Cairo University · Cardiff University · Cardiff and Vale University Health Board · Case Western Reserve University · Cedars-Sinai Medical Center · Centre Hospitalier Universitaire de Besancon · Children's Hospital Los Angeles · Columbia University · Damascus University · Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · David M. Simpson · Dr Salma kafeel Qureshi · ECOG-ACRIN Cancer Research Group · Emergent BioSolutions · Emory University · Endeavor Health · all 211 on the full record

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Kiovig 2006-01-19 europa.eu

Trials 228 · started per year

today
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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 03 trials
Phase 0 NCT03130517 Jul 2017 → Dec 2018 anemia, nonspherocytic hemolytic Assiut University Unknown No outcome recorded
Phase 0 NCT00460928 Apr 2007 → Jun 2009 congenital heart block, neonatal lupus erythematosus NYU Langone Health Completed No outcome recorded
Phase 0 NCT00176059 Oct 2001 → May 2006 chronic renal failure syndrome University of Giessen Completed No outcome recorded
Phase 110 trials
Phase 1 NCT06935266 Apr → Sep 2025 Takeda Completed No outcome recorded
Phase 1 NCT07193953 Apr 2025 → Nov 2026 expected amyotrophic lateral sclerosis Sunnybrook Health Sciences Centre Active not recruiting No outcome recorded
Phase 1 NCT06895967 Mar → Jul 2025 Takeda Completed No outcome recorded
Phase 1 NCT05059977 Oct 2021 → Apr 2022 Takeda Completed No outcome recorded
Phase 1 NCT04643587 Dec 2020 → Mar 2023 bronchiectasis CSL Behring Completed No outcome recorded
Phase 1 NCT04035135 Jan 2020 → May 2021 Guillain-Barre syndrome Annexon, Inc. Completed No outcome recorded
Phase 1 NCT01628055 Mar → Aug 2013 ischemic stroke Inova Health Care Services Withdrawn No outcome recorded
Phase 1 NCT00659386 Feb 2009 → Feb 2010 heart failure Maastricht University Medical Center Unknown No outcome recorded
Phase 1 NCT00195637 Sep 2005 → Jul 2006 hereditary inclusion-body myopathy National Human Genome Research Institute (NHGRI) Completed No outcome recorded
Phase 1 NCT02246855 Aug → Dec 2004 Bio Products Laboratory Completed No outcome recorded
Phase 1/28 trials
Phase 1/2 NCT06064279 Jun 2024 non-small cell lung carcinoma VA Office of Research and Development Withdrawn No outcome recorded
Phase 1/2 NCT03866577 Dec 2018 → Jun 2021 autoimmune thrombocytopenic purpura Momenta Pharmaceuticals, Inc. Terminated No outcome recorded
Phase 1/2 NCT02123615 Jan → Jun 2016 immunodeficiency disease ASIS Corporation Unknown No outcome recorded
Phase 1/2 NCT01854827 Oct 2013 → Jul 2016 biliary atresia National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Completed No outcome recorded
Phase 1/2 NCT01594424 Jun 2012 → Nov 2014 end stage renal failure Cedars-Sinai Medical Center Completed No outcome recorded
Phase 1/2 NCT00845650 Feb 2009 → Oct 2010 anthrax infection Emergent BioSolutions Completed No outcome recorded
Phase 1/2 NCT01757418 Nov 2008 → Dec 2024 sickle cell disease Albert Einstein College of Medicine Completed No outcome recorded
Phase 1/2 NCT00782106 Dec 2006 → Nov 2007 immunodeficiency disease Baxalta now part of Shire Completed No outcome recorded
Phase 259 trials
Phase 2 NCT07674745 Oct 2026 → Sep 2030 expected idiopathic pulmonary fibrosis University of Alabama at Birmingham Not yet recruiting No outcome recorded
Phase 2 NCT07698080 Jul 2026 → Jul 2028 expected aplastic anemia, leukemia, lymphoma, myelodysplastic syndrome +1 Hematology department of the 920th hospital Not yet recruiting No outcome recorded
Phase 2 NCT07561125 Apr 2026 → Sep 2027 expected bronchopulmonary dysplasia International Peace Maternity and Child Health Hospital Recruiting No outcome recorded
Phase 2 NCT07048262 Sep 2025 → Feb 2028 expected bronchiectasis CSL Behring Recruiting No outcome recorded
Phase 2 NCT06976476 May 2025 → May 2029 expected B cell deficiency, acquired immunodeficiency, plasma cell myeloma Memorial Sloan Kettering Cancer Center Recruiting No outcome recorded
Phase 2 NCT06925360 Apr 2025 → Dec 2027 expected bronchopulmonary dysplasia International Peace Maternity and Child Health Hospital Recruiting No outcome recorded
Phase 2 NCT05952804 Jun 2024 → Jul 2028 expected hematopoietic and lymphoid cell neoplasm Fred Hutchinson Cancer Center Recruiting No outcome recorded
Phase 2 NCT06362967 May 2024 → Dec 2026 expected anti-HLA hyperimmunization Anhui Provincial Hospital Recruiting No outcome recorded
Phase 2 NCT06305780 Mar 2024 → Jul 2025 long COVID-19 Kanecia Obie Zimmerman Completed No outcome recorded
Phase 2 NCT04153422 Dec 2023 → Aug 2027 expected autoimmune neuropathy, neuropathy, small fiber, polyneuropathy Endeavor Health Recruiting No outcome recorded
Phase 2/318 trials
Phase 2/3 NCT07202078 May 2025 → Mar 2027 expected leukemia, non-Hodgkin lymphoma, plasma cell myeloma Monash University Recruiting No outcome recorded
Phase 2/3 NCT07202091 May 2025 → Mar 2027 expected leukemia, non-Hodgkin lymphoma, plasma cell myeloma Monash University Recruiting No outcome recorded
Phase 2/3 NCT07202052 May 2025 → Mar 2027 expected leukemia, non-Hodgkin lymphoma, plasma cell myeloma Monash University Recruiting No outcome recorded
Phase 2/3 NCT07202065 Apr 2025 → Mar 2027 expected leukemia, non-Hodgkin lymphoma, plasma cell myeloma Monash University Recruiting No outcome recorded
Phase 2/3 NCT05755035 Oct 2023 → Jan 2026 immunodeficiency disease Takeda Completed No outcome recorded
Phase 2/3 NCT05134792 Oct 2021 → Jul 2022 Cairo University Completed No outcome recorded
Phase 2/3 NCT05832034 Sep 2021 → Sep 2025 overdue antisynthetase syndrome, dermatomyositis, immune-mediated necrotizing myopathy Academic Medical Center - University of Amsterdam Active not recruiting No outcome recorded
Phase 2/3 NCT04261426 Feb → Apr 2020 COVID-19 Peking Union Medical College Hospital Unknown No outcome recorded
Phase 2/3 NCT03560011 Apr 2019 → Jan 2021 idiopathic nephrotic syndrome Assistance Publique - Hôpitaux de Paris Suspended No outcome recorded
Phase 2/3 NCT03730129 Nov 2018 → Jul 2020 immunodeficiency disease Rochester General Hospital Completed No outcome recorded
Phase 388 trials
Phase 3 NCT07552987 Sep 2026 → Jan 2028 expected stiff-person syndrome Kedrion S.p.A. Not yet recruiting No outcome recorded
Phase 3 NCT07648264 Jul 2026 → Feb 2029 expected acquired immunodeficiency CSL Behring Not yet recruiting No outcome recorded
Phase 3 NCT06752356 Jun 2026 → Dec 2027 expected polyneuropathy, inflammatory demyelinating, chronic Kedrion S.p.A. Recruiting No outcome recorded
Phase 3 NCT07582432 Apr 2026 → Aug 2028 expected B-cell neoplasm Grifols Biologicals, LLC Recruiting No outcome recorded
Phase 3 NCT07540221 Apr 2026 → Dec 2027 expected chronic inflammatory demyelinating polyradiculoneuropathy Grifols Therapeutics LLC Recruiting No outcome recorded
Phase 3 NCT07299695 Jan 2026 → Jun 2028 expected idiopathic pulmonary fibrosis Argyrios Tzouvelekis Recruiting No outcome recorded
Phase 3 NCT07346859 Dec 2025 → Apr 2028 expected immunodeficiency disease Biopharma Plasma LLC Recruiting No outcome recorded
Phase 3 NCT07231523 Dec 2025 → Jun 2027 expected AChR+ myasthenia gravis Shanghai Zhongshan Hospital Not yet recruiting No outcome recorded
Phase 3 NCT07059000 Aug 2025 → Aug 2026 overdue primary thrombocytopenia Kedrion S.p.A. Recruiting No outcome recorded
Phase 3 NCT06747351 May 2025 → Jun 2028 expected chronic inflammatory demyelinating polyradiculoneuropathy Takeda Recruiting No outcome recorded
Phase 428 trials
Phase 4 NCT06015750 Jul 2026 → Mar 2030 hypophosphatasia Alexion Pharmaceuticals, Inc. Withdrawn No outcome recorded
Phase 4 NCT07076446 Jul 2025 → Jun 2026 immunodeficiency disease CSL Behring Completed No outcome recorded
Phase 4 NCT06183008 Feb 2024 → Dec 2028 expected idiopathic small fibers neuropathy, neuropathy, painful Sorlandet Hospital HF Not yet recruiting No outcome recorded
Phase 4 NCT05193552 Jan 2024 → Dec 2026 expected common variable immunodeficiency University of Alabama at Birmingham Recruiting No outcome recorded
Phase 4 NCT05520892 Oct 2022 → Aug 2025 overdue primary thrombocytopenia Fujian Medical University Union Hospital Recruiting No outcome recorded
Phase 4 NCT05604859 Aug 2022 → Dec 2023 Qin Ning Unknown No outcome recorded
Phase 4 NCT04616001 Nov 2020 → Jun 2021 COVID-19 Sharp HealthCare Unknown No outcome recorded
Phase 4 NCT02899702 Sep 2020 → Sep 2024 staphylococcal infection, streptococcal infection Hospices Civils de Lyon Withdrawn No outcome recorded
Phase 4 NCT04411667 Apr → Jun 2020 COVID-19 George Sakoulas, MD Completed No outcome recorded
Phase 4 NCT03866798 Jan 2020 → Sep 2023 autoimmune thrombocytopenia Octapharma Terminated No outcome recorded
Phase not applicable14 trials
NCT07068126 Jan → Dec 2025 overdue autoimmune thrombocytopenia Assiut University Recruiting No outcome recorded
NCT06423989 Apr 2023 → Jun 2024 male infertility Dr Salma kafeel Qureshi Unknown No outcome recorded
NCT07532707 Sep 2022 → Oct 2023 myasthenia gravis Damascus University Completed No outcome recorded
NCT03401268 Feb 2018 → May 2019 dysgammaglobulinemia University Health Network, Toronto Completed No outcome recorded
NCT02822027 Jun 2016 → Dec 2024 Daping Hospital and the Research Institute of Surgery of the Third Military Medical University Unknown No outcome recorded
NCT02465359 Sep 2014 → Mar 2018 polyneuropathy, inflammatory demyelinating, chronic University of South Florida Completed No outcome recorded
NCT02043379 May 2014 → Jun 2015 congenital heart disease, immunodeficiency disease University of Alabama at Birmingham Completed No outcome recorded
NCT01785056 Apr 2013 → Jan 2018 diffuse scleroderma Georgetown University Unknown No outcome recorded
NCT00511212 Aug 2007 → Jun 2009 peritonitis Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group Withdrawn No outcome recorded
NCT00615797 May 2002 → Dec 2009 Sydenham chorea, post-bacterial disorder University of Cape Town Completed No outcome recorded
Also used as a comparator or background therapy in 77 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 02 trials
Phase 0 NCT02271165 Comparator Nov 2014 → Mar 2017 dermatomyositis Thomas Jefferson University Terminated No outcome recorded
Phase 0 NCT01841619 Comparator Mar 2013 → Nov 2014 cutaneous lupus erythematosus University of California, Irvine Completed No outcome recorded
Phase 17 trials
Phase 1 NCT06753955 Background Feb → Jul 2025 anti-NMDA receptor encephalitis, autoimmune encephalitis Arialys Therapeutics Completed No outcome recorded
Phase 1 NCT04634435 Background Oct 2021 → Jan 2025 plasma cell myeloma Biohaven Pharmaceuticals, Inc. Completed No outcome recorded
Phase 1 NCT03010046 Background Dec 2016 → Jun 2018 Annexon, Inc. Terminated No outcome recorded
Phase 1 NCT02659891 Comparator May 2016 → Dec 2020 polyomavirus infectious disease Massachusetts General Hospital Completed No outcome recorded
Phase 1 NCT02586051 Background Nov 2015 → Nov 2018 end stage renal failure Hoffmann-La Roche Completed No outcome recorded
Phase 217 trials
Phase 2 NCT06686927 Background Nov 2024 → Sep 2025 overdue autoimmune thrombocytopenia Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Recruiting No outcome recorded
Phase 2 NCT05634824 Comparator Jan 2023 autoimmune thrombocytopenia, pregnancy disorder Peking University People's Hospital Unknown No outcome recorded
Phase 2 NCT05156710 Background Jun 2022 → Oct 2025 overdue transplant rejection Sanofi Active not recruiting No outcome recorded
Phase 2 NCT04728425 Comparator Aug 2020 → Jun 2023 myasthenia gravis University Health Network, Toronto Completed No outcome recorded
Phase 2 NCT03630211 Background Jul 2018 → Aug 2026 overdue diffuse scleroderma, interstitial lung disease, pulmonary hypertension Paul Szabolcs Recruiting No outcome recorded
Phase 2/38 trials
Phase 2/3 NCT07686770 Background Aug 2026 → Sep 2027 expected Kawasaki disease Children's Hospital of Fudan University Not yet recruiting No outcome recorded
Phase 2/3 NCT05104762 Comparator Sep 2021 → Mar 2022 Guillain-Barre syndrome Assiut University Completed No outcome recorded
Phase 2/3 NCT03829566 Background Nov 2019 → Jan 2025 neuromyelitis optica Northwestern University Withdrawn No outcome recorded
Phase 2/3 NCT03593902 Background May 2018 → Oct 2019 systemic sclerosis Northwestern University Terminated No outcome recorded
Phase 2/3 NCT02205762 Background Nov 2016 → Jul 2026 overdue Langerhans cell histiocytosis North American Consortium for Histiocytosis Active not recruiting No outcome recorded
Phase 328 trials
Phase 3 NCT07220915 Comparator Jun 2026 → Dec 2029 expected autoimmune disease, dysgammaglobulinemia, infectious disease, rheumatic disorder Octapharma Not yet recruiting No outcome recorded
Phase 3 NCT06920004 Comparator Aug 2025 → Sep 2027 expected polyneuropathy, inflammatory demyelinating, chronic argenx Recruiting No outcome recorded
Phase 3 NCT06867991 Comparator Nov 2024 → Nov 2026 expected anti-NMDA receptor encephalitis The First People's Hospital of Changzhou Recruiting No outcome recorded
Phase 3 NCT06290141 Comparator Aug 2024 → Jul 2027 expected polyneuropathy, inflammatory demyelinating, chronic Sanofi Recruiting No outcome recorded
Phase 3 NCT04656184 Comparator Oct 2023 → Mar 2027 expected Kawasaki disease Assistance Publique - Hôpitaux de Paris Recruiting No outcome recorded
Phase 44 trials
Phase 4 NCT05494593 Background Feb 2023 → Aug 2025 mucopolysaccharidosis type 2 Takeda Withdrawn No outcome recorded
Phase 4 NCT04589299 Comparator Jun 2020 → Dec 2030 expected polyneuropathy, inflammatory demyelinating, chronic University of Aarhus Recruiting No outcome recorded
Phase 4 NCT06223984 Comparator Mar → Nov 2020 Konya City Hospital Completed No outcome recorded
Phase 4 NCT01179893 Comparator Mar 2007 → Jul 2010 myasthenia gravis University Health Network, Toronto Completed No outcome recorded
Phase not applicable10 trials
NCT05114941 Comparator Jan → Dec 2026 expected Guillain-Barre syndrome The First Affiliated Hospital of Zhengzhou University Not yet recruiting No outcome recorded
NCT03647852 Comparator Sep 2019 → Feb 2026 overdue immunoglobulin A vasculitis Children's Hospital of Fudan University Recruiting No outcome recorded
NCT03412188 Comparator Aug 2018 → Sep 2021 autoimmune thrombocytopenic purpura Nayera Hazaa Elsherif Completed No outcome recorded
NCT02449746 Comparator Aug 2015 → Aug 2017 autoimmune disease, schizophrenia University of Cambridge Completed No outcome recorded
NCT01547143 Background Mar 2012 → May 2016 secondary hemophagocytic lymphohistiocytosis Asan Medical Center Terminated No outcome recorded
Phase not stated1 trial
NCT06955793 Background immunodeficiency disease Takeda Available No outcome recorded

Press releases naming this drug 64 releases

DateIssuerRelease
2026-06-15 AstraZeneca Ultomiris granted Priority Review in the US as treatment for adults with immunoglobulin A nephropathy astrazeneca.com
2026-06-06 AstraZeneca Ultomiris demonstrated 43.4% reduction in proteinuria vs placebo in adults with immunoglobulin A nephropathy at 34 weeks in I CAN Phase III trial astrazeneca.com
2026-05-04 Takeda Takeda Announces Positive Topline Results from Pivotal Phase 2/3 Clinical Trial of TAK-881 in Primary Immunodeficiency Disease (PID) takeda.com
2026-04-21 AstraZeneca Ultomiris demonstrated statistically significant and clinically meaningful reduction of proteinuria in adults with immunoglobulin A nephropathy in I CAN Phase III trial astrazeneca.com
2025-06-30 Takeda Takeda Announces U.S. FDA Approval of GAMMAGARD LIQUID ERC, the Only Ready-to-Use Liquid Immunoglobulin Therapy with Low Immunoglobulin A (IgA) Content 1 takeda.com
2024-01-29 Takeda Takeda’s GAMMAGARD LIQUID ® Approved by U.S. FDA for Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) takeda.com
2024-01-03 CSL Behring CSL Behring Announces Availability of Hizentra® (Immune Globulin Subcutaneous [Human] 20% Liquid) 10g Prefilled Syringe csl.com
2023-09-25 Takeda Takeda Announces Approval of CUVITRU Subcutaneous Immunoglobulin in Japan for Patients with Agammaglobulinemia or Hypogammaglobulinemia takeda.com
2023-04-18 CSL Behring CSL Behring Receives FDA Approval for Hizentra® (Immune Globulin Subcutaneous [Human] 20% Liquid) 50mL Prefilled Syringe csl.com
2021-08-09 CSL Behring The European Academy of Neurology (EAN) and Peripheral Nerve Society (PNS) Task Force Has Strongly Recommended Subcutaneous Immunoglobulin (SCIg) for CIDP Maintenance Treatment csl.com
2021-06-08 CSL Behring Hizentra® (Immune Globulin Subcutaneous [Human] 20% Liquid) To Be Covered Under Medicare Part B Effective July 18, Improving Access and Reducing Out-of-Pocket Costs for CIDP Patients csl.com
2021-04-29 CSL Behring Hizentra® (Immune Globulin Subcutaneous [Human] 20% Liquid) Label Update Provides New Dosing Guidelines for Physicians, Allowing for Greater Flexibility in Treating CIDP Patients csl.com

Evidence & citations 80 cited values

Every value below carries the sentence it was read from. 316 sources stand behind the page.

FieldValueCited text
Known as Immune Globulin Intravenous (Human) “The investigators propose a double-blind controlled trial of 24 patients with Privigen® (Immune Globulin Intravenous (Human), 10% liquid treatment) with 3:1 randomization.” NCT01785056
14

“Active treatment will be intravenous immunoglobulin G (Gamunex, immune globulin intravenous \[human\], 10%), at a dose of 2 g/kg divided over five days (0.4 g/kg/day).” NCT00850005

Immune Globulin Intravenous (Human), 10% (GAMMAGARD LIQUID/KIOVIG) Administered Intravenously or Subcutaneously” NCT00814320

NCT01524887

NCT00666263

NCT00090194

NCT01406470

NCT00157079

NCT00389324

NCT00546871

NCT00220805

NCT00220766

NCT05832034

NCT00161993

NCT00162006

Known as 10% = Immune Globulin Intraveneous (Human) 10% = Immune Globulin Intraveneous (Human)NCT00782106
Known as Bivigam ClinicalTrials.gov intervention name — accepted as the source's own label NCT03164967
Known as CSL787 ClinicalTrials.gov intervention name — accepted as the source's own label NCT04643587
1

NCT07048262

Known as Cuvitru “weekly 20% subcutaneous IG (SCIG; Cuvitru, Ig20Gly)” PMID 34036490 May 2021
Known as Flebogamma 5% DIF ClinicalTrials.gov intervention name — accepted as the source's own label NCT02176863
1

NCT00634569

Known as Gamimune N “IVIG, either Gamimune N (Talecris Biotherapeutics, Inc., Clayton, NC) or Gamunex 10% (Talecris Biotherapeutics, Inc., Clayton, NC), both as a 10% solution” NCT00606905
1

NCT01556347

Known as Gammagard “A Placebo-controlled, Randomized, Double-Blind Phase II Clinical Study of Gammagard Intravenous Immunoglobulin (IVIg) for Treatment of Mild to Moderate Alzheimer's Disease” NCT00299988
1

NCT02123615

Known as Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)]NCT02123615
Known as GAMMAGARD LIQUID “In the US the product is licensed (trade name GAMMAGARD LIQUID) for the intravenous (IV) and SC replacement therapy of antibody deficiency in patients with PID.” NCT01175213
2

“During this safety follow-up period, participants underwent treatment with the licensed product IGI, 10% (Gammagard Liquid).” NCT01485796

“Immune Globulin Intravenous (Human), 10% (GAMMAGARD LIQUID/KIOVIG)” NCT00814320

Known as GAMMAGARD LIQUID, 10% “Efficacy, safety, and pharmacokinetics of a 10% liquid immune globulin preparation (GAMMAGARD LIQUID, 10%) administered subcutaneously in subjects with primary immunodeficiency disease.” PMID 21424824 Mar 2011
Known as GAMMAGARD LIQUID/KIOVIG ClinicalTrials.gov intervention name — accepted as the source's own label NCT02549170
Known as gammaglobulin “To test the efficacy of intravenous gamma globulin (IVGG) in preventing coronary artery aneurysms in children with Kawasaki Syndrome.” NCT00000520
5

“IV gammaglobulinNCT01547143

gammaglobulinNCT03412188

NCT00661401

NCT00001261

NCT02540720

Known as GAMMAPLEX “The main objective of this study is to see if GAMMAPLEX is efficacious with respect to Food and Drug Administration (FDA) minimal requirements (no more than 1 serious, acute,...” NCT00278954
6

“Gammargard, Gammaplex, Gamunex, or Octogam IGIV Product” NCT02269163

NCT02246855

NCT00278954

NCT01289847

NCT02199925

NCT00504075

Known as Gammaplex 5% IGIV Gammaplex 5% IGIV administered intravenously” NCT02199925
Known as GAMUNEX “Active treatment will be intravenous immunoglobulin G (Gamunex, immune globulin intravenous \[human\], 10%), at a dose of 2 g/kg divided over five days (0.4 g/kg/day).” NCT00850005
7

“Placebo followed by IVIG 1 g/kg (Gamunex® Immune Globulin Intravenous \[Human\], 10%; Bayer)\* x 1 dose” NCT00376077

“both given over 1 hour, followed in both cases by IVIG (Gamunex 10%) 1 g/kg over 2-3 hours” PMID 32282882 Apr 2020

GAMUNEX® (immune globulin intravenous (human) 10% caprylate/chromatography purified).” NCT00845650

“Gammargard, Gammaplex, Gamunex, or Octogam IGIV Product” NCT02269163

NCT00417573

NCT00845650

NCT01281969

Known as Gamunex 10% “IVIG, either Gamimune N (Talecris Biotherapeutics, Inc., Clayton, NC) or Gamunex 10% (Talecris Biotherapeutics, Inc., Clayton, NC), both as a 10% solution” NCT00606905
Known as Gamunex-C “Subcutaneous Immune Globulin Injection (Human), 10 % Caprylate/Chromatography Purified (GAMUNEX®-C) in Pediatric Patients with Primary Immunodeficiency Disease.” PMID 27342758 Jun 2016
10

Gamunex-C \[immune globulin injection (human) 10% caprylate/chromatography purified\] is a sterile solution of human immune globulin protein.” NCT03401073

“Gamunex®-C Plus Standard Medical Treatment to Prevent Infections” NCT07582432

NCT02042027

NCT02549170

NCT07540221

NCT01465958

NCT07582432

NCT04561115

NCT04450654

NCT04480424

Known as Hizentra “A Pilot Study to Assess Tolerability of Subcutaneous Immunoglobulin Treatment (Hizentra) in Patients Undergoing Allogeneic Hematopoietic Cell Transplantation” NCT03401268
8

“Immunoglobulin (HIZENTRA) subcutaneously 0.54 g/kg/week for 26 weeks.” NCT04589299

“IgPro20 (Subcutaneous Immunoglobulin, Hizentra®)” NCT04137224

“Drug: Immunoglobulin (Hizentra)” NCT02271165

NCT03730129

NCT02711228

NCT01354587

NCT02100969

NCT05193552

Known as human gamma globulin ClinicalTrials.gov intervention name — accepted as the source's own label NCT02822027
Known as human immunoglobulin “Treatment of Hypersensitivity Syndrome (DRESS) With Tegeline® (Human Immunoglobulin)” NCT00505648
1

human immunoglobulin infusion (IVIg)” NCT00004833

Known as human immunoglobulin G ClinicalTrials.gov intervention name — accepted as the source's own label NCT04044690
Known as Human normal Immunoglobulin Human normal immunoglobulin 200 mg/mL (including immunoglobulin G (IgG) no less than 95 %) administered subcutaneously.” NCT07346859
6

“Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.” NCT00426270

“Biological: Kiovig® (Human normal Immunoglobulin for intravenous administration 100mg/mL)” NCT01951924

“(Intravenous) Human Normal Immunoglobulin (IVIg) 10%” NCT07059000

“Intravenous human normal immunoglobulin (IVIg) 10%” NCT07552987

“Gammaplex® (Human Normal Immunoglobulin)” NCT02246855

NCT04826588

Known as human normal immunoglobulin 10% “The dose of NewGam, solvent/detergent treated human normal immunoglobulin 10%, remained the same throughout the study, as long as the minimum trough level of serum...” NCT01313507
Known as Human normal immunoglobulin G (IgG) ClinicalTrials.gov intervention name — accepted as the source's own label NCT02774239