Drugs / Immunoglobulins
Immunoglobulins
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01828294 | Oct 2011 → Dec 2017 | AChR+ myasthenia gravis | St. Louis University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 23 trials | ||||||
| Phase 2 | NCT06373211 | Jan 2025 → Jun 2028 expected | paraneoplastic sensory ganglionopathy | Assistance Publique - Hôpitaux de Paris | Recruiting | No outcome recorded |
| Phase 2 | NCT06159283 | Mar 2024 → Jun 2025 | COVID-19 | Jaehoon Ko | Unknown | No outcome recorded |
| Phase 2 | NCT03289403 | Mar 2018 → Sep 2023 | autoimmune thyroid disease, infertility disorder | Aljazeera Hospital | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT04222023 | Aug 2022 → Aug 2025 | — | University Hospital, Strasbourg, France | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 21
| Date | Issuer | Release |
|---|---|---|
| 2025-07-10 | Beijing Tiantan Biological Products Co., Ltd. | Results 国内首研20%皮下注射人免疫球蛋白（SCIG）：开启免疫治疗新时代 tiantanbio.com ↗
长达1年的安全性观察显示，本品不良反应以轻、中度为主，全身性不良反应发生率低。 |
| 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. |
| 2024-06-18 | Takeda | Results Takeda Presents Long-Term Data from Phase 3 ADVANCE-CIDP 3 Clinical Trial of HYQVIA® in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) at PNS Annual Meeting takeda.com ↗
Results showed favorable long-term safety and tolerability of HYQVIA, and a low relapse rate, supporting its use as maintenance treatment for CIDP. |
| 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 |
| 2022-07-21 | Takeda | Results Takeda Announces Positive Topline Results from Pivotal Phase 3 Clinical Trial Evaluating HYQVIA ® for Maintenance Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) takeda.com ↗
Topline data show that HYQVIA reduced relapse of neuromuscular disability and impairment when used as a maintenance therapy for CIDP, supporting its potential as a facilitated subcutaneous immunoglobulin (fSCIG) solution that could allow for monthly infusion for many CIDP patients. |
| 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. |
| 2019-03-26 | CSL Behring | Regulatory Japan’s Ministry of Health, Labour and Welfare Approves CSL Behring Immunoglobulins to Treat Patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) csl.com ↗
Global biotherapeutics leader CSL Behring announced today that Japan’s Ministry of Health, Labour and Welfare has approved two of its immunoglobulin therapies for the treatment of patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). |
| 2019-02-14 | Fab'entech | Results In Vitro Characterization and In Vivo Effectiveness of Ebola Virus Specific Equine Polyclonal F(ab’)2 fabentech.com ↗
Highly purified equine anti-Ebola F(ab’)2 showed strong cross-neutralization of 2 Zaire EBOV strains (Gabon 2001 and Makona) and in vivo 3 or 5 daily F(ab’)2 intraperitoneal injections provided 100% protection to BALB/c mice against lethal EBOV challenge. |
| 2017-12-21 | SAb Biotherapeutics, Inc. | Results First-In-Human Trial Of New Immunotherapy Approach Shows Efficacy In Antibiotic Resistance sab.bio ↗
SAb Biotherapeutics, a clinical-stage biopharmaceutical development company, announced today its first-in-human trial of new immunotherapy approach has shown efficacy in antibiotic-resistant bacteria based on a recent paper published online in Clinical Infectious Diseases. |
| 2017-11-09 | CSL Behring | Results Lancet Neurology Publishes Results from CSL Behring Phase III Study of Hizentra® (Immune Globulin Subcutaneous [Human] 20% liquid) as Maintenance Therapy in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) csl.com ↗
The study met its primary efficacy endpoint, demonstrating that 39 percent of patients on low-dose Hizentra (0.2 g/kg weekly) and 33 percent of patients on high-dose Hizentra (0.4 g/kg weekly) experienced a CIDP relapse or withdrew from the study over a 24-week treatment period (p values of 0.007 and 0.001 respectively, as measured by one-sided Fisher’s exact tests) compared with 63 percent of patients on placebo. |
| 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 ↗ |
| 2013-04-04 | CSL Behring | Regulatory European Commission Grants Marketing Authorization to CSL Behring’s Privigen® in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) csl.com ↗ |
| 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. |
| 2011-03-21 | CSL Behring | Results Study demonstrates relationship between subcutaneous IgG (SCIg) dosage and clinical outcomes with Hizentra treatment in patients with primary immunodeficiencies csl.com ↗
Data presented by CSL Behring today suggest that treatment with higher dose Hizentra® (IgPro 20) correlates with reduced risk of infection and missed school or work among patients with primary immunodeficiencies (PI). |
| 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. |
| 2009-05-01 | CSL Behring | Regulatory CSL Behring Submits BLA Requesting Approval of Subcutaneous Human Immunoglobulin for Use as Replacement Therapy in Patients with Primary Immunodeficiencies csl.com ↗
Submission of this BLA reinforces our commitment to serving the PI and rare disease community. |
All press releases naming this drug 23 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Immunoglobulins | “3. Immunoglobulins will be used in cases not responding to treatment.” NCT03289403 ↗ |
| Known as | CLAYRIG | “Immunoglobulins IV (CLAYRIG)” NCT06373211 ↗ |
| Known as | IGSC | “subcutaneous immunoglobulin (SCIG or IGSC) as a maintenance therapy” NCT01828294 ↗ |
| Known as | intravenous immunoglobulin | “intravenous immunoglobulin (IVIG) replacement therapy” NCT06159283 ↗ |
| Known as | IVIG | “intravenous immunoglobulin (IVIG) replacement therapy” NCT06159283 ↗1“Intravenous immunoglobulins (IVIG)” NCT04222023 ↗ |
| Known as | SCIG | “subcutaneous immunoglobulin (SCIG or IGSC) as a maintenance therapy” NCT01828294 ↗ |
| Modality | Protein / enzyme biologic | “which is a plasma protein” NCT01828294 ↗ |
| Route | Subcutaneous | “Immunoglobulins used subcutaneously” NCT01828294 ↗ |