Drugs / Immune Globulin Intravenous (Human)
Immune Globulin Intravenous (Human)
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed polyneuropathy, inflammatory demyelinating, chronic 1 milestone | |||||
| Filed | EU (EMA) | Privigen | polyneuropathy, inflammatory demyelinating, chronic | 2012-05-31 | “CSL Behring Submits Marketing Authorization Variation Application to European Medicines Agency (EMA) for Privigen® in Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)” csl.com ↗ “Recently, CSL Behring submitted a Variation Application to the European Medicines Agency (EMA) for the use of Privigen in CIDP.” csl.com ↗ “it has submitted a Variation Application to the European Medicines Agency (EMA) for the use of Privigen” csl.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Kiovig | — | 2006-01-19 | europa.eu ↗ |
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT04643587 | Dec 2020 → Mar 2023 | bronchiectasis | CSL Behring | Completed | No outcome recorded |
| Phase 1 | NCT01628055 | Mar → Aug 2013 | ischemic stroke | Inova Health Care Services | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT02246855 | Aug → Dec 2004 | — | Bio Products Laboratory | Completed | No outcome recorded |
| Phase 1/25 trials | ||||||
| Phase 1/2 | NCT06064279 | Jun 2024 | non-small cell lung carcinoma | VA Office of Research and Development | Withdrawn | No outcome recorded Stop: Business |
| 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 | 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 218 trials · 3 missed | ||||||
| Phase 2 | NCT07048262 | Sep 2025 → Feb 2028 expected | bronchiectasis | CSL Behring | 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 | NCT06577909 | Oct 2023 → Dec 2024 overdue | autoimmune thrombocytopenia | Peking University People's Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04609761 | Jan 2021 → Oct 2025 | pediatric acute-onset neuropsychiatric syndrome | Göteborg University | Completed | No outcome recorded |
| Phase 2 | NCT04400994 | Jun 2020 → Dec 2025 overdue | pemphigus | The University of Hong Kong | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04403269 | May 2020 → May 2021 | COVID-19 | Versailles Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT03174951 | Sep 2016 → Mar 2017 | pregnancy loss, recurrent, 4 | Tabriz University of Medical Sciences | Completed | No outcome recorded |
| Phase 2 | NCT01845584 | May 2013 → Aug 2015 | neuromyelitis optica spectrum disorder with anti-AQP4 antibodies | Nihon Pharmaceutical Co., Ltd | Completed | No outcome recorded |
| Phase 2 | NCT01300728 | Jan 2011 → Mar 2020 | cognitive impairment with or without cerebellar ataxia | Sutter Health | Completed | Missed primary |
| Phase 2 | NCT00986947 | Sep 2009 → Jul 2011 | kidney failure | Johns Hopkins University | Terminated | No outcome recorded |
| Phase 2 | NCT00389324 | Nov 2006 → Aug 2008 | inborn error of immunity | Grifols Therapeutics LLC | Completed | No outcome recorded |
| Phase 2 | NCT00294476 | Jul 2005 → ? | colorectal cancer, malignant urinary system neoplasm, melanoma | GammaCan | Unknown | No outcome recorded |
| Phase 2 | NCT00115778 | Jun 2005 → Aug 2009 | dysgammaglobulinemia | Columbia University | Completed | Missed primary |
| Phase 2 | NCT00220805 | Jan 2004 → May 2005 | macular degeneration | Grifols Therapeutics LLC | Completed | Missed primary |
| Phase 2 | NCT00090194 | Jun 2003 → Mar 2004 | chronic renal failure syndrome | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | No outcome recorded |
| Phase 2 | NCT00162006 | Jan → Dec 2003 | autoimmune thrombocytopenic purpura | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 2 | NCT00161993 | Jun 2002 → Sep 2003 | agammaglobulinemia | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 2/35 trials | ||||||
| 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 | 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 | NCT01485796 | Dec 2011 → Jan 2013 | immunodeficiency disease | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 2/3 | NCT01225276 | Oct 2011 → Oct 2012 | chronic inflammatory demyelinating polyradiculoneuropathy | Octapharma | Terminated | No outcome recorded |
| Phase 2/3 | NCT00546871 | Oct 2007 → Jul 2009 | immunodeficiency disease | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 340 trials · 5 met primary · 3 missed | ||||||
| Phase 3 | NCT06752356 | Oct 2026 → Dec 2027 expected | polyneuropathy, inflammatory demyelinating, chronic | Kedrion S.p.A. | Recruiting | No outcome recorded |
| Phase 3 | NCT07552987 | Sep 2026 → Jan 2028 expected | stiff-person syndrome | Kedrion S.p.A. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07346859 | Dec 2025 → Apr 2028 expected | immunodeficiency disease | Biopharma Plasma LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT07059000 | Aug 2025 → Dec 2026 expected | primary thrombocytopenia | Kedrion S.p.A. | Recruiting | No outcome recorded |
| Phase 3 | NCT06533098 | Feb 2025 → Dec 2027 expected | fetal and neonatal alloimmune thrombocytopenia | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT06089122 | Apr 2024 → Jan 2025 | immunodeficiency disease | Azidus Brasil | Unknown | No outcome recorded |
| Phase 3 | NCT05177939 | Mar 2022 → May 2024 | autoimmune encephalitis | Nihon Pharmaceutical Co., Ltd | Unknown | No outcome recorded |
| Phase 3 | NCT04640142 | Aug 2021 → Sep 2026 overdue | immunodeficiency disease | Octapharma | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04474223 | Aug 2020 → Dec 2028 expected | atrioventricular block | NYU Langone Health | Recruiting | No outcome recorded |
| Phase 3 | NCT04500067 | May → Sep 2020 | COVID-19, pneumonia | Biopharma Plasma LLC | Completed | No outcome recorded |
| Phase 3 | NCT04044690 | Oct 2019 → Dec 2024 | dermatomyositis | CSL Behring | Terminated | Missed primary |
| Phase 3 | NCT03700138 | Jun 2019 → Apr 2025 | neuropathy, painful | University Hospital, Strasbourg, France | Completed | No outcome recorded |
| Phase 3 | NCT03342638 | Nov 2017 → Jul 2019 | relapsing-remitting multiple sclerosis | Northwestern University | Terminated | No outcome recorded |
| Phase 3 | NCT02638207 | Sep 2017 → Sep 2019 | chronic inflammatory demyelinating polyradiculoneuropathy | Octapharma | Completed | No outcome recorded |
| Phase 3 | NCT02806986 | Jun 2016 → May 2019 | immunodeficiency disease | Grifols Therapeutics LLC | Completed | No outcome recorded |
| Phase 3 | NCT02374736 | Feb 2016 → Mar 2018 | — | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 3 | NCT02549170 | Dec 2015 → Feb 2022 | chronic inflammatory demyelinating polyradiculoneuropathy | Baxalta now part of Shire | Completed | Met primary |
| Phase 3 | NCT02221271 | Oct 2014 → Aug 2015 | Guillain-Barre syndrome | Nihon Pharmaceutical Co., Ltd | Completed | No outcome recorded |
| Phase 3 | NCT01951924 | Dec 2013 → Jul 2016 | motor neuron disorder | LFB | Completed | No outcome recorded |
| Phase 3 | NCT01827072 | Apr 2013 → Jun 2015 | multifocal motor neuropathy | Nihon Pharmaceutical Co., Ltd | Completed | No outcome recorded |
| Phase 3 | NCT01824251 | Apr 2013 → Sep 2015 | polyneuropathy, inflammatory demyelinating, chronic | Nihon Pharmaceutical Co., Ltd | Completed | No outcome recorded |
| Phase 3 | NCT01736579 | Nov 2012 → Jun 2013 | Alzheimer disease | Baxalta now part of Shire | Terminated | No outcome recorded |
| Phase 3 | NCT01524887 | Jan 2012 → Jul 2013 | Alzheimer disease | Baxalta now part of Shire | Terminated | Missed primary |
| Phase 3 | NCT01349790 | Oct 2011 → Jul 2013 | primary thrombocytopenia | Octapharma | Completed | No outcome recorded |
| Phase 3 | NCT01461018 | Oct 2011 → Jul 2014 | immunodeficiency disease | CSL Behring | Completed | No outcome recorded |
| Phase 3 | NCT01406470 | Sep 2011 → Jul 2013 | immunodeficiency disease | Green Cross Corporation | Completed | No outcome recorded |
| Phase 3 | NCT01313507 | May 2011 → Sep 2012 | immunodeficiency disease | Octapharma | Completed | No outcome recorded |
| Phase 3 | NCT01458171 | Apr 2011 → Feb 2012 | immunodeficiency disease | CSL Behring | Completed | No outcome recorded |
| Phase 3 | NCT01184846 | Nov 2010 → Nov 2011 | polyneuropathy, inflammatory demyelinating, chronic | CSL Behring | Completed | Met primary |
| Phase 3 | NCT01175213 | Jul 2010 → Aug 2013 | immunodeficiency disease | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 3 | NCT01012323 | Jan 2010 → Jun 2012 | immunodeficiency disease | Octapharma | Completed | No outcome recorded |
| Phase 3 | NCT00818662 | Dec 2008 → Dec 2012 | Alzheimer disease | Baxalta now part of Shire | Completed | Missed primary |
| Phase 3 | NCT00814320 | Dec 2008 → Nov 2010 | immunodeficiency disease | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 3 | NCT00666263 | Aug 2008 → Aug 2011 | multifocal motor neuropathy | Baxalta now part of Shire | Completed | Met primary |
| Phase 3 | NCT00504075 | Sep 2007 → Aug 2011 | autoimmune thrombocytopenic purpura | Bio Products Laboratory | Completed | Met primary |
| Phase 3 | NCT00426270 | Jun 2006 → Sep 2008 | autoimmune thrombocytopenic purpura | Octapharma | Completed | Met primary |
| Phase 3 | NCT00278954 | Jan 2006 → Nov 2007 | Wiskott-Aldrich syndrome, common variable immunodeficiency, hyper-IgM syndrome | Bio Products Laboratory | Completed | No outcome recorded |
| Phase 3 | NCT00306033 | Mar 2004 → May 2005 | myasthenia gravis | University Health Network, Toronto | Completed | No outcome recorded |
| Phase 3 | NCT00220766 | Aug 2002 | Wiskott-Aldrich syndrome, common variable immunodeficiency, severe combined immunodeficiency | Grifols Therapeutics LLC | Completed | No outcome recorded |
| Phase 3 | NCT00157079 | Jun 2002 → Dec 2003 | Kawasaki disease, autoimmune thrombocytopenic purpura, inborn error of immunity | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 48 trials | ||||||
| Phase 4 | NCT06015750 | Jul 2026 → Mar 2030 | hypophosphatasia | Alexion Pharmaceuticals, Inc. | Withdrawn | No outcome recorded Stop: Business |
| 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 | NCT03348618 | Nov 2017 → Nov 2019 | PANDAS | IMMUNOe Research Centers | Unknown | No outcome recorded |
| Phase 4 | NCT03351933 | Oct 2017 → Apr 2018 | — | Grifols Therapeutics LLC | Completed | No outcome recorded |
| Phase 4 | NCT03116347 | May 2017 → Jan 2021 | immunodeficiency disease | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 4 | NCT02199925 | Jun 2013 → Apr 2015 | autism | Isaac Melamed | Unknown | No outcome recorded |
| Phase 4 | NCT01289847 | Mar 2011 → Apr 2014 | Bruton-type agammaglobulinemia, Wiskott-Aldrich syndrome, common variable immunodeficiency, hyper-IgM syndrome | Bio Products Laboratory | Completed | No outcome recorded |
| Phase not applicable5 trials | ||||||
| — | NCT06423989 | Apr 2023 → Jun 2024 | male infertility | Dr Salma kafeel Qureshi | Unknown | 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 |
| Comparator or background therapy33 trials | ||||||
| Phase 0 | NCT01841619 Comparator | Mar 2013 → Nov 2014 | cutaneous lupus erythematosus | University of California, Irvine | 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 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 | NCT02669277 Comparator | Aug 2015 → Feb 2016 | autoimmune thrombocytopenic purpura | Ain Shams University | Unknown | No outcome recorded |
| Phase 2 | NCT02111161 Comparator | Apr 2014 → Sep 2016 | fournier gangrene, gas gangrene, necrotizing fasciitis, necrotizing soft tissue infection | Anders Perner | Completed | No outcome recorded |
| Phase 2 | NCT01769027 Comparator | Jun → Dec 2013 | — | CNS Onlus | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00809822 Comparator | Nov 2008 → Oct 2010 | bullous pemphigoid | Nihon Pharmaceutical Co., Ltd | Completed | No outcome recorded |
| 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 | 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 | NCT01522235 Comparator | Feb 2012 → May 2014 | autoimmune autonomic ganglionopathy | Beth Israel Deaconess Medical Center | Completed | No outcome recorded |
| Phase 2/3 | NCT01412385 Background | Jun 2011 → May 2014 | immunodeficiency disease | Baxalta now part of Shire | Completed | Met primary |
| Phase 2/3 | NCT01203345 Comparator | Jan 1988 → Mar 1991 | fetal growth restriction, infectious disease with sepsis | NICHD Neonatal Research Network | Completed | No outcome recorded |
| Phase 3 | NCT06920004 Comparator | Aug 2025 → Sep 2027 expected | polyneuropathy, inflammatory demyelinating, chronic | argenx | Recruiting | No outcome recorded |
| Phase 3 | NCT06290141 Comparator | Aug 2024 → Jul 2027 expected | polyneuropathy, inflammatory demyelinating, chronic | Sanofi | Recruiting | No outcome recorded |
| Phase 3 | NCT06534450 Comparator | Sep 2022 → Nov 2023 overdue | — | Dobri Kiprov | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04935177 Background | Oct 2021 → Jun 2025 | — | Hansa Biopharma AB | Completed | No outcome recorded |
| Phase 3 | NCT04826588 Comparator | May 2021 → Nov 2022 | COVID-19–associated multisystem inflammatory syndrome in children | University Children's Hospital Basel | Completed | No outcome recorded |
| Phase 3 | NCT04535518 Background | Oct 2020 → Sep 2022 | Kawasaki disease | Children's Hospital of Fudan University | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT04302805 Comparator | Jul 2020 → Apr 2024 | — | Institute for Clinical and Experimental Medicine | Completed | No outcome recorded |
| Phase 3 | NCT04078568 Background | Jan 2020 → Dec 2024 | Kawasaki disease | Children's Hospital of Fudan University | Completed | Missed primary |
| Phase 3 | NCT03939637 Comparator | May 2019 → Apr 2024 | autoimmune thrombocytopenia | Baylor College of Medicine | Completed | Met primary |
| Phase 3 | NCT03742115 Comparator | Dec 2018 → Dec 2019 | hemophagocytic syndrome | Beijing Friendship Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT03065244 Comparator | Feb 2017 → Aug 2020 | Kawasaki disease | University of California, San Diego | Completed | No outcome recorded |
| Phase 3 | NCT02269163 Comparator | Jan 2016 → Jan 2019 | immunodeficiency disease | Prometic Biotherapeutics, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01621204 Comparator | Oct 2012 → Jun 2019 | autoimmune thrombocytopenic purpura | McMaster University | Completed | Met primary |
| Phase 3 | NCT01408550 Comparator | Aug 2011 → Sep 2013 | bullous pemphigoid | Nihon Pharmaceutical Co., Ltd | Completed | No outcome recorded |
| Phase 4 | NCT01179893 Comparator | Mar 2007 → Jul 2010 | myasthenia gravis | University Health Network, Toronto | Completed | No outcome recorded |
| — | NCT03647852 Comparator | Sep 2019 → Feb 2026 overdue | immunoglobulin A vasculitis | Children's Hospital of Fudan University | Recruiting | No outcome recorded |
| — | NCT01361178 Comparator | Jan 2011 → Jan 2016 | respiratory infections, recurrent, and failure to thrive with or without diarrhea | University of Pittsburgh | Completed | No outcome recorded |
| — | NCT00606905 Comparator | Nov 1999 → Mar 2009 | habitual spontaneous abortion, pregnancy loss, recurrent, 4 | University of Chicago | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 57
| Date | Issuer | Release |
|---|---|---|
| 2025-07-24 | Beijing Tiantan Biological Products Co., Ltd. | Regulatory 百年传奇焕新上市 守护健康新高度 tiantanbio.com ↗
如今，国药天坛蓉生第四代层析静丙2.5g新规格的补充获批，更是让这份“守护”变得更精准、更贴心。 |
| 2025-06-10 | Octapharma | Results Octapharma Releases Results for Phase 3 Superiority Study of Pediatric Acuteonset Neuropsychiatric Syndrome octapharma.com ↗
From baseline (week 0) to week 9, there was a mean improvement of 31.1% (SD 40.68) in the PANZYGA ® group CY-BOCS score as compared to 12.1% (SD 68.39) in the placebo group. |
| 2025-04-08 | Octapharma | Results Octapharma presents new clinical data investigating frontiers of treatment for autoimmune disorders at American Academy of Neurology conference octapharma.com ↗
In these analyses, panzyga ® demonstrated a significant higher proportion of patients with confirmed evidence of clinical improvement (ECI) of 85% for panzyga ® 1.0g/kg and 92% for panzyga® 2.0g/kg maintenance dose versus 67% for subcutaneous efgartigimod alfa. |
| 2025-03-13 | Grifols Therapeutics LLC | Results Grifols Phase 2/3 trial shows positive impact of immunoglobulin therapy on post-polio patients grifols.com ↗
This study met its primary endpoint of enhanced physical performance in the two-minute walk distance (2MWD) after the one-year treatment period. |
| 2024-12-30 | Halozyme Therapeutics | Regulatory Halozyme Announces Takeda Received Regulatory Approval for HYQVIA® 10% Subcutaneous Injection Set with ENHANZE® in Japan for Patients with Agammaglobulinemia or Hypogammaglobulinemia halozyme.com ↗
Takeda received regulatory approval for HYQVIA® [Immune Globulin Infusion 10% (Human) with Halozyme's Recombinant Human Hyaluronidase] by the Japanese Ministry of Health, Labour and Welfare (MHLW) |
| 2024-06-17 | Grifols Therapeutics LLC | Regulatory Grifols’ Biotest receives FDA approval for innovative Yimmugo® immunoglobulin to treat primary immunodeficiencies grifols.com ↗
U.S. approval of Yimmugo paves the way for other Biotest proteins in late-stage development, including fibrinogen and trimodulin |
| 2024-03-11 | ADMA Biologics, Inc. | Regulatory ADMA Biologics Announces FDA Approvals of Extended Room Temperature Storage Conditions for ASCENIV™ & BIVIGAM® admabiologics.com ↗
The room temperature approval applies to all existing ASCENIV and BIVIGAM lots currently in the commercial supply chain as well as to future production of ASCENIV and BIVIGAM. |
| 2024-01-29 | Takeda | Regulatory Takeda’s GAMMAGARD LIQUID ® Approved by U.S. FDA for Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) takeda.com ↗
Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved GAMMAGARD LIQUID ® [Immune Globulin Infusion (Human) 10% solution] as an intravenous immunoglobulin (IVIG) therapy to improve neuromuscular disability and impairment in adults with chronic inflammatory demyelinating polyneuropathy (CIDP). |
| 2024-01-29 | Halozyme Therapeutics | Regulatory Halozyme Announces Takeda Received European Commission Approval for HYQVIA® Co-formulated with ENHANZE® as Maintenance Therapy for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) halozyme.com ↗
Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that Takeda received European Commission (EC) approval for HYQVIA® [Immune Globulin Infusion 10% (Human)] co-formulated with Halozyme's ENHANZE® drug delivery technology as maintenance therapy in patients of all ages with chronic inflammatory demyelinating polyneuropathy (CIDP) after stabilization with intravenous immunoglobulin therapy (IVIG). |
| 2024-01-16 | Halozyme Therapeutics | Regulatory Halozyme Announces Takeda Receives FDA Approval for HYQVIA® Co-formulated with ENHANZE® as Maintenance Therapy in Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) halozyme.com ↗ |
| 2023-12-12 | ADMA Biologics, Inc. | Regulatory ADMA Biologics Announces FDA Approval for BIVIGAM® in the Pediatric Patient Setting for Those 2 Years of Age and Older admabiologics.com ↗
today announced the U.S. Food and Drug Administration (“FDA”) has approved the Company’s supplemental Biologics License Application submitted under section 351(a) of the Public Health Service Act for BIVIGAM. |
| 2023-11-13 | Grifols Therapeutics LLC | Regulatory Grifols receives FDA approval for expanded immunoglobulin purification and filling capacity at its North Carolina site grifols.com ↗
The FDA approval is specifically for Gamunex ® -C, a leading Grifols Ig brand. |
| 2022-12-13 | ADMA Biologics, Inc. | Regulatory ADMA Biologics Announces FDA Approval for Room Temperature Storage of ASCENIV™ & BIVIGAM® admabiologics.com ↗
FDA approvals for both ASCENIV and BIVIGAM provide for room temperature (25°C) storage conditions for up to 4 weeks during the first 24 months of the 36-month approved shelf life |
| 2022-10-06 | Octapharma | Results ProDERM study results of octagam® 10% treatment in patients with dermatomyositis published in the New England Journal of Medicine octapharma.com ↗
The results of the study demonstrated that octagam® 10% is an efficacious and well-tolerated treatment for adults with dermatomyositis. |
| 2022-03-25 | ADMA Biologics, Inc. | Regulatory ADMA Biologics Announces FDA Approval of Extended Shelf Life for ASCENIV™ & BIVIGAM® from 24 to 36 Months admabiologics.com ↗ |
| 2021-10-04 | ADMA Biologics, Inc. | Results ADMA Biologics Announces the Presentation of Real-World Experience in the Management of Respiratory Syncytial Virus (RSV) Presented at IDWeek 2021 admabiologics.com ↗
The two cases presented detailed scenarios in which ASCENIV administration demonstrated notable benefits in the clinical course of two children diagnosed with primary immunodeficiency (PI) and documented RSV infection. |
| 2021-08-30 | Octapharma | Regulatory FDA Orphan Drug approval: Octapharma’s Octagam® 10% receives 7 years of market exclusivity for adult dermatomyositis octapharma.com ↗
the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) has awarded seven years of marketing exclusivity for Octagam ® 10% |
| 2021-06-02 | Octapharma | Regulatory European and German authorities approve octagam® 10% for adults with dermatomyositis octapharma.com ↗
Octapharma announced today that octagam® 10%, a human plasma-derived intravenous immunoglobulin (IVIg), has recently been granted approval in the European Union (EU) as an immunomodulatory therapy for adults with dermatomyositis. |
| 2021-04-28 | ADMA Biologics, Inc. | Regulatory ADMA Biologics Receives FDA Approval for Increased IVIG Production Scale admabiologics.com ↗ |
| 2021-04-15 | Grifols Therapeutics LLC | Results GigaGen Publishes Research on Company’s Recombinant Hyperimmunes in Nature Biotechnology grifols.com ↗
Additionally, the publication shows proofs-of-concept for other polyclonal drugs, including a Zika hyperimmune, a high-potency spike-in intravenous immunoglobulin (IVIG)-mixture for primary immune deficiency and a recombinant version of ATG for transplant tolerance. |
| 2021-04-02 | Takeda | Results CoVIg-19 Plasma Alliance Announces Topline Results from NIH-Sponsored Clinical Trial of Investigational COVID-19 Hyperimmune Globulin Medicine takeda.com ↗
No serious safety signals were raised in the trial. |
| 2021-04-02 | Grifols Therapeutics LLC | Results Grifols announces topline data from NIAID Phase 3 ITAC trial (INSIGHT-013) evaluating hyperimmune globulins as a treatment for hospitalized patients with COVID-19 grifols.com ↗
did not meet its primary endpoints with statistically significant results. |
| 2021-04-02 | CSL Behring | Results CoVIg-19 Plasma Alliance Announces Topline Results from NIH-Sponsored Clinical Trial of Investigational COVID-19 Hyperimmune Globulin Medicine csl.com ↗
No serious safety signals were raised in the trial. |
| 2021-04-02 | Emergent BioSolutions | Results Emergent BioSolutions Announces Topline Data from NIAID Phase 3 ITAC Trial (INSIGHT-013) Evaluating Immunoglobulins as a Treatment for Hospitalized Patients with COVID-19 emergentbiosolutions.com ↗
There were no serious safety concerns identified. |
| 2021-03-31 | Kamada, Ltd. | Results Kamada Announces Top-line Results from its Phase 1/2 Clinical Trial of its Plasma-Derived Hyperimmune Globulin (IgG) Treatment for Coronavirus Disease (COVID-19) kamada.com ↗
Kamada Ltd. (NASDAQ & TASE: KMDA), a plasma-derived biopharmaceutical company, today announced top-line results from its Phase 1/2 open-label, single-arm, multi-center clinical trial in Israel of the Company’s anti-SARS-CoV-2 plasma-derived hyperimmune globulin (IgG) treatment for coronavirus disease (COVID-19). |
| 2021-02-12 | Pfizer | Regulatory U.S. FDA Approves PANZYGA® for the Treatment of Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) pfizer.com ↗
Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for PANZYGA ® (Immune Globulin Intravenous [Human] – ifas 10% Liquid Preparation) to treat adult patients with a rare neurological disease of the peripheral nerves called chronic inflammatory demyelinating polyneuropathy (CIDP). |
| 2020-07-27 | Grifols Therapeutics LLC | Results Results of Grifols’ AMBAR clinical trial published in Alzheimer's & Dementia: The Journal of the Alzheimer’s Association grifols.com ↗
The findings of the AMBAR clinical trial demonstrate a delay in the cognitive and functional decline in AD patients when their plasma is replaced with albumin and immunoglobulin (plasma-derived proteins) following the process of plasma extraction, using the plasmapheresis technique. |
| 2020-07-15 | Octapharma | Results Octapharma Reports Positive Data from octagam® Usage in Critically Ill COVID-19 Patients octapharma.com ↗
The data shows that IVIG treatment reduces inflammation, which is associated with poor clinical outcomes and death, and points to an increase in survival, in critically ill COVID-19 patients, when compared to a control group. |
| 2020-06-03 | Octapharma | Results Octapharma USA extends funding for COVID-19 study following positive preliminary research data octapharma.com ↗
To date the study has observed: Six patients in the SOC arm and two patients in the IVIG arm required intubation. |
| 2020-05-20 | Octapharma | Regulatory FDA approves Octapharma USA investigational new drug application for severe COVID-19 patients octapharma.com ↗
The U.S. Food and Drug Administration (FDA) has approved the investigational new drug (IND) application submitted by Octapharma USA for a phase three clinical trial on the efficacy and safety of Octagam® 10% [Immune Globulin Intravenous (Human)] therapy in COVID-19 patients with severe disease progression. |
| 2020-02-11 | CSL Behring | Regulatory PRIVIGEN® (Immune Globulin Intravenous (Human), 10% Liquid) Granted Orphan-Drug Designation for the Investigational Treatment of Systemic Sclerosis (SSc) csl.com ↗
Global biotherapeutics leader CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has granted Privigen® (Immune Globulin Intravenous (Human),10% Liquid) orphan-drug designation as an investigational therapy in the treatment of Systemic Sclerosis (SSc). |
| 2019-07-08 | ADMA Biologics, Inc. | Regulatory ADMA Biologics Receives FDA Approval for License Transfers for BIVIGAM® and Nabi-HB® admabiologics.com ↗ |
| 2019-05-10 | ADMA Biologics, Inc. | Regulatory FDA Approves Prior Approval Supplement for BIVIGAM® admabiologics.com ↗
The FDA’s approval of the PAS for BIVIGAM® approves the use of the Company’s optimized intravenous immune globulin (“IVIG”) manufacturing process and enables ADMA to commence the marketing of BIVIGAM® in the U.S. to patients with Primary Humoral Immunodeficiency (“PI”). |
| 2019-04-02 | ADMA Biologics, Inc. | Regulatory ADMA Receives Department of Health and Human Services U.S. License admabiologics.com ↗
The license covers the Boca Raton, FL manufacturing facility which has demonstrated compliance with FDA requirements as well as authorizes ADMA to manufacture and enter into interstate commerce with ASCENIV™. |
| 2019-04-01 | ADMA Biologics, Inc. | Regulatory FDA Approves ASCENIV™, a Novel Intravenous Immune Globulin admabiologics.com ↗ |
| 2019-01-07 | ADMA Biologics, Inc. | Regulatory ADMA Biologics Submits Response and Provides Supplemental Information to FDA for BIVIGAM® Complete Response Letter admabiologics.com ↗ |
| 2018-12-20 | ADMA Biologics, Inc. | Regulatory ADMA to Host Conference Call to Discuss Recent Regulatory Update on BIVIGAM® PAS Submissions admabiologics.com ↗
the FDA’s Complete Response Letter (“CRL”), received on Wednesday, December 19th, in response to the Company’s drug substance Prior Approval Supplement (“PAS”) submission and previously approved drug product PAS submission. |
| 2018-12-19 | ADMA Biologics, Inc. | Regulatory ADMA Biologics Provides Regulatory Update on BIVIGAM® PAS Submissions admabiologics.com ↗ |
| 2018-10-11 | ADMA Biologics, Inc. | Regulatory ADMA Biologics Provides Regulatory Update for BIVIGAM® admabiologics.com ↗
As a result, the FDA has informed the Company that they require an additional two months to complete their review of the PAS submitted in June 2018 to amend the Biologics License Application (“BLA”) for BIVIGAM®. |
| 2018-07-26 | ADMA Biologics, Inc. | Regulatory ADMA Biologics Receives PDUFA Date for BIVIGAM® Regulatory Submission admabiologics.com ↗ |
| 2017-09-14 | CSL Behring | Regulatory CSL Behring Announces FDA Approval of Privigen® [Immune Globulin Intravenous (Human), 10% Liquid] for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in Adults csl.com ↗
Global biotherapeutics leader CSL Behring today announced that the U.S. Food and Drug Administration (FDA) has approved Privigen® [Immune Globulin Intravenous (Human), 10% Liquid] for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP) to improve neuromuscular disability. |
| 2017-02-14 | CSL Behring | Regulatory FDA Accepts CSL Behring’s Biologics License Application Supplement for Using Privigen® to Treat Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), a Rare Neurological Condition csl.com ↗ |
| 2016-04-12 | ADMA Biologics, Inc. | Results ADMA Biologics Announces Data on RI-002 to be Presented at the Clinical Immunology Society 2016 Annual Meeting admabiologics.com ↗
In addition, the data presented will also demonstrate that RI-002 prevents infection in cotton rats challenged with influenza and suppresses inflammatory cytokines induced by influenza. |
| 2015-11-03 | ADMA Biologics, Inc. | Results ADMA Biologics Announces Data to be Presented at the International Primary Immunodeficiencies Congress in Budapest Hungary admabiologics.com ↗
The data also demonstrates the presence of higher anti- RSV neutralizing activity in RI-002 as compared to that which is present in palivizumab in this animal model. |
| 2014-10-30 | CSL Behring | Results Evidence presented at the 16th Biennial Meeting of the European Society for Immunodeficiencies (ESID) Supports Individualized Dosing with Hizentra® csl.com ↗
The interim results as measured by the Treatment Satisfaction Questionnaire for Medication (TSQM) showed overall improvement over baseline with the manual push administration technique in all four dimensions for evaluation (effectiveness, side effects, convenience, and overall satisfaction). |
| 2014-07-31 | Halozyme Therapeutics | Regulatory FDA Advisory Committee Panel Provides Favorable Recommendation on Baxter’s HyQvia for Primary Immunodeficiency halozyme.com ↗ |
| 2013-12-02 | Halozyme Therapeutics | Regulatory Baxter Submits Amended BLA to U.S. FDA for HyQvia for Primary Immunodeficiency halozyme.com ↗
Baxter and Halozyme submitted additional preclinical data that was requested from the FDA in 2012, and expect a six-month review period. |
| 2013-10-29 | ADMA Biologics, Inc. | Results RSV Vaccines for the World 2013 Conference Presentation Highlights Data from ADMA Biologics’ Human and Animal Study Experience admabiologics.com ↗
The data presented at the 2013 RSVVW demonstrates the potential for offering a polyclonal immune globulin product with standardized, elevated levels of anti-RSV antibodies in immune-compromised patient populations, |
| 2013-04-04 | CSL Behring | Regulatory European Commission Grants Marketing Authorization to CSL Behring’s Privigen® in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) csl.com ↗ |
| 2013-02-21 | CSL Behring | Regulatory CSL Behring Announces New Vial Size of Privigen® for Treatment of Primary Immunodeficiency and Chronic Immune Thrombocytopenic Purpura csl.com ↗
CSL Behring today announced that the United States Food and Drug Administration has approved a 40 g (400 mL) vial size for Privigen® , immune globulin intravenous [human]. |
| 2012-06-27 | CSL Behring | Results PRIMA Study Shows Treatment with Privigen® Improved Function in Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) csl.com ↗
PRIMA, a prospective, multicenter, open-label, single-arm study investigating the efficacy and safety of Privigen in previously IVIG-treated and untreated patients with CIDP achieved its primary efficacy endpoint, which was the percentage of patients responding—as measured by the Inflammatory Neuropathy Cause and Treatment (INCAT) scale—at study completion compared to baseline. |
| 2012-05-31 | CSL Behring | Regulatory CSL Behring Submits Marketing Authorization Variation Application to European Medicines Agency (EMA) for Privigen® in Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) csl.com ↗
CSL Behring announced today that it has submitted a Variation Application to the European Medicines Agency (EMA) for the use of Privigen ® (immune globulin intravenous [human], 10 percent liquid for intravenous administration) in Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP). |
| 2012-03-04 | CSL Behring | Results Analysis Finds Bioavailability of IgG Is Consistent, Regardless of Formulation csl.com ↗
Based on an analysis of published data, the study found that bioavailability – the percentage of unchanged drug that reaches the circulation – was similar among four subcutaneous IgG (SCIg) preparations and all fell within the range of 66.7± 2.7 percent as compared to intravenous IgG. |
| 2010-10-07 | CSL Behring | Results Study Demonstrates Safety and Efficacy of Subcutaneous Vivaglobin as First-Line Therapy for Primary Immunodeficiency csl.com ↗
The study found that IgG replacement therapy initiated with Vivaglobin in patients with PI provided adequate serum IgG levels, protected the patients from infections, and improved health-related quality of life, without raising safety concerns. |
| 2010-10-07 | CSL Behring | Results Privigen Demonstrates Efficacy and Tolerability Among Patients With Various Immunodeficiencies, Data Show csl.com ↗
Results also demonstrate that Privigen offers significant protection against infection. |
| 2010-04-19 | CSL Behring | Regulatory CSL Behring Receives FDA Approval to Extend Shelf Life for Privigen® from 24 to 36 Months csl.com ↗
19 Apr 2010 CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) to extend the shelf life for Privigen®, Immune Globulin Intravenous (Human), 10% Liquid, from 24 to 36 months. |
| 2007-03-21 | Emergent BioSolutions | Regulatory Emergent BioSolutions Files Investigational New Drug Application With FDA for Pivotal Anthrax Immune Globulin Clinical Trial emergentbiosolutions.com ↗
Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the company's Anthrax Immune Globulin (AIG) product candidate. |
All press releases naming this drug 76 releases
Evidence & citations 46 cited values
Every value below carries the sentence it was read from. 121 sources stand behind the page.
| Field | Value | Cited 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 ↗13“Immune Globulin Intravenous (Human), 10% (GAMMAGARD LIQUID/KIOVIG) Administered Intravenously or Subcutaneously” NCT00814320 ↗ |
| Known as | 10% = Immune Globulin Intraveneous (Human) | “10% = Immune Globulin Intraveneous (Human)” NCT00782106 ↗ |
| Known as | CSL787 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07048262 ↗ |
| 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 ↗ |
| Known as | GAMMAGARD | ClinicalTrials.gov intervention name — accepted as the source's own label 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 | 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 ↗ |
| Known as | Gammaplex 5% IGIV | “Gammaplex 5% IGIV administered intravenously” NCT02199925 ↗ |
| 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 | human gamma globulin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02822027 ↗ |
| 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 ↗ |
| 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 | IGI, 10% | “IGSC, 10% is abbreviated to IGI, 10% \[IMMUNE GLOBULIN INFUSION (HUMAN), 10%\]” NCT01175213 ↗ |
| Known as | IgIV | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04403269 ↗ |
| Known as | IGIV, 10% | “The purpose of this study is to evaluate the tolerability of IGIV, 10% given subcutaneously and the pharmacokinetics of immunoglobulin G (IgG) following subcutaneous (SC)...” NCT00546871 ↗4“The purpose of this study is to assess the safety and efficacy of Immune Globulin Intravenous (Human), 10% (IGIV 10%) in subjects with primary immunodeficiency disorders.” NCT00157079 ↗ “IGSC, 10% is the same product as IMMUNE GLOBULIN INTRAVENOUS (HUMAN), 10% (IGIV, 10%)” NCT01175213 ↗ “Immune Globulin Intravenous (Human), 10% (IGIV, 10%) 400 mg/kg” NCT00818662 ↗ “Immune Globulin Intravenous (Human), 10% (IGIV, 10%)” NCT01736579 ↗ |
| Known as | IGIV-C | “Evaluation of Immune Globulin Intravenous (Human), 10%, Manufactured by Chromatography Process (IGIV-C, 10%), as an Agent to Reduce Anti-HLA Antibodies and Improve...” NCT00090194 ↗ |
| Known as | IGIV-C, 10% | “Evaluation of Immune Globulin Intravenous (Human), 10%, Manufactured by Chromatography Process (IGIV-C, 10%), as an Agent to Reduce Anti-HLA Antibodies and Improve...” NCT00090194 ↗ |
| Known as | IgPro20 | “IgPro20 is a 20% (weight per volume \[w/v\]) liquid formulation of human immunoglobulin for subcutaneous (SC) use.” NCT01458171 ↗ |
| Known as | IGSC | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01175213 ↗ |
| Known as | IGSC 20% | “Approximately 60 subjects will be enrolled in order to have approximately 20 adult subjects and 20 pediatric subjects treated with subcutaneously administered Immune Globulin...” NCT02806986 ↗ |
| Known as | Immune Globulin (Human) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03351933 ↗ |
| Known as | Immune Globulin Infusion (Human) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01485796 ↗ |
| Known as | IMMUNE GLOBULIN INFUSION (HUMAN), 10% | “IGSC, 10% is abbreviated to IGI, 10% \[IMMUNE GLOBULIN INFUSION (HUMAN), 10%\]” NCT01175213 ↗ |
| Known as | Immune Globulin Intravenous | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01757418 ↗ |
| Known as | Immune Globulin Intravenous (Human), 10% | “Immune Globulin Intravenous (Human), 10%, IGIV-C, 10%” NCT00606905 ↗ |
| Known as | Immune Globulin Intravenous (Human), 10% (IGIV, 10%) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01736579 ↗ |
| Known as | Immune Globulin Intravenous (Human), 10%, IGIV-C, 10% | “Immune Globulin Intravenous (Human), 10%, IGIV-C, 10%” NCT00606905 ↗ |
| Known as | Immune globulin subcutaneous (Human) | “Approximately 60 subjects will be enrolled in order to have approximately 20 adult subjects and 20 pediatric subjects treated with subcutaneously administered Immune Globulin...” NCT02806986 ↗ |
| Known as | Immunoglobulin Intravenous (Human) 10% | “High Infusion Rate Study of Immunoglobulin Intravenous (Human) 10% (NewGam)” NCT01313507 ↗ |
| Known as | intravenous immunoglobulin | “The purpose of this research is to study the effects of Privigen (intravenous immunoglobulin) on the skin in patients with scleroderma.” NCT01785056 ↗ |
| Known as | IVIg | “This study is a double-blind, placebo-controlled, randomized clinical trial to determine whether IVIG is effective in improving motor scores in patients with myasthenia gravis...” NCT00306033 ↗51“IVIG is a fractionated blood product whose off-label use for treating a variety of conditions, including spontaneous recurrent miscarriage, has continued to grow in recent years.” PMID 17166218 ↗ Dec 2006 “The purpose of this study is to determine whether Intravenous Immunoglobulin (IVIG) is safe and effective in the acute treatment of pain crises in sickle cell disease.” NCT01757418 ↗ “OBJECTIVE: We tested biweekly infusions of IV immunoglobulin (IVIg) as a possible treatment for mild to moderate Alzheimer disease (AD) dementia.” PMID 28381506 ↗ Apr 2017 “Human normal immunoglobulin (IVIg) 2g/kg intravenously as a single dose in line with guidance for dosing and administration in Kawasaki disease” NCT04826588 ↗ “intravenous immunoglobulin (IVIG) can prevent bacterial infections in lung transplant patients with low serum levels of immunoglobulin.” NCT00115778 ↗ “IVIG, 400mg/kg/d, intravenous administration, continuous administration for 3-5 days.” NCT06686927 ↗ “IVIg: IVIG 1 g/kg x1 (no steroids for pre-medication or adjunctive therapy)” NCT03939637 ↗ “IVIg would be given in combination with Rituximab intravenously.” NCT04400994 ↗ “One dose of IVIG” NCT04474223 ↗ |
| Known as | IVIG-SN | “The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics of Immune Globulin Intravenous (Human) IVIG-SN™ in subjects with primary immunodeficiency diseases.” NCT01406470 ↗ |
| Known as | KIOVIG | “Gammagard and Kiovig are the brand names for the same immunoglobulin compound.” NCT02549170 ↗4“Immune Globulin Intravenous (Human), 10% (GAMMAGARD LIQUID/KIOVIG)” NCT00814320 ↗ “In the EU this product is licensed (trade name KIOVIG)” NCT01175213 ↗ |
| Known as | NewGam | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02638207 ↗ |
| Known as | Newnorm | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04640142 ↗ |
| Known as | NPB-01 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01824251 ↗ |
| Known as | Octagam 10% | “Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.” NCT00426270 ↗ |
| Known as | Privigen | “Efficacy and safety of Privigen(®) in patients with chronic inflammatory
demyelinating polyneuropathy: results of a prospective, single-arm, open-label
Phase III study (the...” PMID 23781960 ↗ Jun 20138“Single administration of intravenous immunoglobulin solution Privigen® (CSL Behring AG, Bern, Switzerland) at a dose of 2g / kg.” NCT02899702 ↗ |
| Known as | QIVIGY | “The purpose of this study is to evaluate the efficacy and safety of QIVIGY (Intravenous Human Normal Immune Globulin 10%) compared with placebo in adult participants with stiff...” NCT07552987 ↗1“A Study Investigating Intravenous Human Normal Immune Globulin (IGIV) 10% KIg10 (QIVIGY) in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)” NCT06752356 ↗ |
| Action | Inhibit | “Evaluation of Immune Globulin Intravenous (Human), 10%, Manufactured by Chromatography Process (IGIV-C, 10%), as an Agent to Reduce Anti-HLA Antibodies” NCT00090194 ↗ |
| Modality | Protein / enzyme biologic | “immune globulin intravenous (IVIG)” PMID 25090414 ↗ Aug 2014 |
| Route | Intravenous | “receive IGIV-C, 10% intravenously at a dose of either 2 gm/kg, 1 gm/kg, or 0.5 gm/kg” NCT00090194 ↗ |