Drugs / intravenous immune globulin
intravenous immune globulin
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02287064 | Apr 2015 → Dec 2016 | cerebellar ataxia | University of South Florida | Unknown | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03992482 | May → Aug 2019 | dry eye syndrome | Sandeep Jain, MD | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT04432324 | Jun 2020 → Mar 2021 | COVID-19 | Grifols | Completed | No outcome recorded |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT02728752 | Feb 2017 → Nov 2019 | dermatomyositis | Octapharma | Completed | Met primary |
| Phase not applicable1 trial | ||||||
| — | NCT00586716 | Nov 2004 → Sep 2009 | end stage renal failure | Loma Linda University | Terminated | No outcome recorded Stop: Enrollment |
| Comparator or background therapy2 trials | ||||||
| Phase 4 | NCT04033276 Comparator | Jan 2019 → Dec 2021 | — | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02525172 Background | Aug 2015 → Jul 2020 | glycogen storage disease II | National Taiwan University Hospital | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 17
| 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。 |
| 2025-04-08 | 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. |
| 2024-06-17 | 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 |
| 2024-01-29 | Takeda | Regulatory Takeda’s GAMMAGARD LIQUID ® Approved by U.S. FDA for Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) takeda.com ↗ |
| 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. |
| 2022-10-06 | 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. |
| 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. |
| 2021-04-15 | 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 | 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. |
| 2020-11-06 | Octapharma | Results Positive results from ProDERM study of octagam® 10% in patients with dermatomyositis meeting the primary endpoint will be presented at ACR Convergence 2020 octapharma.com ↗
The primary endpoint of the study was met, with a significantly higher proportion of responders in the octagam® 10% group compared with the placebo group (78.7% vs 43.8%; p=0.0008) |
| 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. |
| 2020-05-18 | Octapharma | Results Final results from the ProCID study of efficacy and safety of 3 different dosages of Panzyga® (NewGam) in patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) presented at AAN 2020 octapharma.com ↗
The results of the study confirmed the efficacy of Panzyga® in adults with CIDP at the standard dose of 1.0 g/kg every 3 weeks. |
All press releases naming this drug 17 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | intravenous immune globulin | “BACKGROUND: Intravenous immune globulin (IVIG) for the treatment of dermatomyositis has not been extensively evaluated.” PMID 36198179 ↗ Oct 2022 |
| Known as | GAMMAGARD LIQUID | “IVIG will be infused over a course of five days in the form of GAMMAGARD LIQUID 10% solution, available from Baxter.” NCT02287064 ↗ |
| Known as | intravenous immunoglobulin | “The phase 3 ProDERM study demonstrated intravenous immunoglobulin (IVIg) was safe and effective in patients with dermatomyositis (DM).” PMID 39918968 ↗ Jun 2025 |
| Known as | IVIg | “The phase 3 ProDERM study demonstrated intravenous immunoglobulin (IVIg) was safe and effective in patients with dermatomyositis (DM).” PMID 39918968 ↗ Jun 20252“Intravenous Immune Globulin (IVIG)” NCT02287064 ↗ “Intravenous Immunoglobulin (IVIG)” NCT03992482 ↗ |
| Known as | Octagam 10% | “IVIg (Octagam 10%; Octapharma AG)” PMID 38233885 ↗ Jan 2024 |
| Modality | Protein / enzyme biologic | “intravenous immunoglobulin (IVIg)” PMID 40616720 ↗ Jul 2025 |
| Route | Intravenous | “intravenous immune globulin is administered to patients” NCT00586716 ↗ |