Drugs / Immunoglobulin
last change Aug 2026 re-read 3 minutes ago

Immunoglobulin

Protein / enzyme biologic

Developed for
bronchopulmonary dysplasia · acquired immunodeficiency · Alzheimer disease · demyelinating polyneuropathy · idiopathic nephrotic syndrome · inborn error of immunity · intracerebral hemorrhage · neuromyelitis optica
+10 more · paraneoplastic neurologic syndrome · pregnancy loss, recurrent, 4 · primary thrombocytopenia · thrombocytopenia due to immune destruction · transverse myelitis · dermatomyositis · multifocal motor neuropathy · pneumonia · polyneuropathy, inflammatory demyelinating, chronic · transplant rejection
Investigated by
Assistance Publique - Hôpitaux de Paris · International Peace Maternity and Child Health Hospital · Alder Hey Children's NHS Foundation Trust · Barts & The London NHS Trust · Barts and the London School of Medicine and Dentistry · Birmingham Women's and Children's NHS Foundation Trust
+39 more · Cardiff University · Cardiff and Vale University Health Board · Fujian Medical University Union Hospital · Great Ormond Street Hospital for Children NHS Foundation Trust · Green Cross Corporation · Grifols Biologicals, LLC · Grifols, S.A. · Guy's and St Thomas' NHS Foundation Trust · King's College Hospital NHS Trust · King's College London · LFB · Liaocheng People's Hospital · Linyi People's Hospital · Longyan City First Hospital · Manchester University NHS Foundation Trust · NHS Lothian · Nanping First Hospital Affiliated to Fujian Medical University · Newcastle-upon-Tyne Hospitals NHS Trust · North Bristol NHS Trust · Northern Care Alliance NHS Foundation Trust · Nottingham University Hospitals NHS Trust · Oxford University Hospitals NHS Trust · Qingdao University · Quanzhou First Hospital · Rochester General Hospital · Shandong University · Shanghai First Maternity and Infant Hospital · The Affiliated Hospital Of Guizhou Medical University · The Affiliated Hospital of Putian University · The First Affiliated Hospital of Xiamen University · The Second Hospital of Anhui Medical University · University College, London · University Hospital Birmingham NHS Foundation Trust · University Hospital Southampton NHS Foundation Trust · University Hospital of Saint-Etienne · University Hospitals Bristol and Weston NHS Foundation Trust · Walton Centre NHS Foundation Trust · Wei Wang · Zhangzhou Affiliated Hospital of Fujian Medical University

Trials 13

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 24 trials
Phase 2 NCT07561125 Apr 2026 → Sep 2027 expected bronchopulmonary dysplasia International Peace Maternity and Child Health Hospital 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 NCT02782897 Jun 2016 → Dec 2017 intracerebral hemorrhage Wei Wang Unknown No outcome recorded
Phase 2 NCT02343211 Nov 2013 → Jun 2016 paraneoplastic neurologic syndrome Assistance Publique - Hôpitaux de Paris Completed No outcome recorded
Phase 2/33 trials
Phase 2/3 NCT03560011 Apr 2019 → Jan 2021 idiopathic nephrotic syndrome Assistance Publique - Hôpitaux de Paris Suspended No outcome recorded
Phase 2/3 NCT03211065 Jul 2017 → Nov 2019 acquired immunodeficiency Rochester General Hospital Completed No outcome recorded
Phase 2/3 NCT01561053 Apr 2012 → Mar 2018 Alzheimer disease Grifols, S.A. Completed No outcome recorded
Phase 34 trials
Phase 3 NCT03492710 Apr 2019 inborn error of immunity Green Cross Corporation Withdrawn No outcome recorded Stop: Business
Phase 3 NCT02834468 Jun 2016 → Jul 2018 thrombocytopenia due to immune destruction Shandong University Unknown No outcome recorded
Phase 3 NCT02398994 Mar 2015 → Mar 2016 neuromyelitis optica, transverse myelitis Guy's and St Thomas' NHS Foundation Trust Terminated No outcome recorded Stop: Enrollment
Phase 3 NCT01349270 Jun 2004 → Dec 2013 demyelinating polyneuropathy University Hospital of Saint-Etienne Completed No outcome recorded
Phase 42 trials
Phase 4 NCT05520892 Oct 2022 → Aug 2025 overdue primary thrombocytopenia Fujian Medical University Union Hospital Recruiting No outcome recorded
Phase 4 NCT02990403 Oct 2014 → Jun 2017 pregnancy loss, recurrent, 4 Shanghai First Maternity and Infant Hospital Unknown No outcome recorded
Comparator or background therapy7 trials
Phase 0 NCT02271165 Comparator Nov 2014 → Mar 2017 dermatomyositis Thomas Jefferson University Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT01895127 Comparator Nov 2013 → Apr 2016 transplant rejection Brigham and Women's Hospital Terminated No outcome recorded
Phase 2 NCT00268788 Comparator Aug 2005 → Feb 2008 multifocal motor neuropathy University of Aarhus Completed No outcome recorded
Phase 3 NCT04381936 Comparator Mar 2020 → Sep 2028 expected pneumonia University of Oxford Recruiting No outcome recorded
Phase 3 NCT03200561 Comparator Oct 2013 → Dec 2020 Kawasaki disease National Taiwan University Hospital Unknown No outcome recorded

Press releases naming this drug 51 releases

DateIssuerRelease
2025-05-21 Grifols Therapeutics LLC Grifols receives FDA clearance of IND application for Phase 2 trial of immunoglobulin drops for dry eye disease grifols.com ↗
2025-03-13 Grifols Therapeutics LLC Grifols Phase 2/3 trial shows positive impact of immunoglobulin therapy on post-polio patients grifols.com ↗
2024-10-22 Grifols Therapeutics LLC Grifols partners with BARDA for proof-of-concept testing of ocular immunoglobulin as treatment for sulfur mustard-induced eye injury grifols.com ↗
2024-06-17 Grifols Therapeutics LLC Grifols’ Biotest receives FDA approval for innovative Yimmugo® immunoglobulin to treat primary immunodeficiencies grifols.com ↗
2024-06-17 Grifols Therapeutics LLC Grifols’ Biotest receives FDA approval for innovative Yimmugo® immunoglobulin to treat primary immunodeficiencies grifols.com ↗
2024-01-03 CSL Behring CSL Behring Announces Availability of Hizentra® (Immune Globulin Subcutaneous [Human] 20% Liquid) 10g Prefilled Syringe csl.com ↗
2023-11-13 Grifols Therapeutics LLC Grifols receives FDA approval for expanded immunoglobulin purification and filling capacity at its North Carolina site grifols.com ↗
2023-11-13 Grifols Therapeutics LLC Grifols receives FDA approval for expanded immunoglobulin purification and filling capacity at its North Carolina site grifols.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 8 cited values

Every value below carries the sentence it was read from. 21 sources stand behind the page.

FieldValueCited text
Known as immunoglobulin “intravenous immunoglobulin (given intravenously at a dose of 5g per month for 6 months)” NCT02834468 ↗
19

NCT00268788 ↗

NCT01895127 ↗

NCT02990403 ↗

NCT02782897 ↗

NCT02398994 ↗

NCT03211065 ↗

NCT02271165 ↗

NCT04589299 ↗

NCT03492710 ↗

NCT03200561 ↗

Show 9 more sources

Known as Hizentra “Immunoglobulin (HIZENTRA) subcutaneously 0.54 g/kg/week for 26 weeks.” NCT04589299 ↗
1

“Drug: Immunoglobulin (Hizentra)” NCT02271165 ↗

Known as Immunoglobulin subcutaneous (human) 20% liquid, Hizentra “Immunoglobulin subcutaneous (human) 20% liquid, Hizentra” NCT02271165 ↗
Known as intravenous immune globulin “intravenous immune globulin (IVIG)” NCT05520892 ↗
Known as IVIg “Intravenous immunoglobulin (IVIG) is often used as second-line treatment in steroid-unresponsive central nervous system demyelination” NCT02398994 ↗
4

“intravenous immunoglobulin (IVIg) could help to reduce symptoms.” PMID 38353301 ↗ Feb 2024

“human intravenous immunoglobulin (IVIg)” NCT02343211 ↗

“intravenous immune globulin (IVIG)” NCT05520892 ↗

“Intravenous immunoglobulin (IVIg)” NCT04381936 ↗

Known as PRIVIGEN “Immunoglobulin (PRIVIGEN) intravenously 2 g/kg/4week for 26 weeks.” NCT04589299 ↗
Modality Protein / enzyme biologic “Immunoglobulin preparations are now available for subcutaneous use as IgG replacement therapy.” NCT00268788 ↗
Route Subcutaneous “Subcutaneous Ig given twice a week.” NCT00268788 ↗