Drugs / Human immunoglobulin
Human immunoglobulin
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | Yimmugo | primary thrombocytopenia | 2023-09-07 | “US Food and Drug Administration FDA akzeptiert den Zulassungsantrag für Immunglobulin Yimmugo” biotest.com ↗ |
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 33 trials · 1 missed | ||||||
| Phase 3 | NCT07233213 | Nov 2025 → Dec 2026 expected | autoimmune thrombocytopenic purpura | Grand Shuyang Life Sciences (Chengdu) Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT04350580 | Apr → Nov 2020 | COVID-19, acute respiratory distress syndrome | Centre Hospitalier St Anne | Completed | Missed primary |
| Phase 3 | NCT03238079 | Sep 2017 → Aug 2020 | inborn error of immunity | Evolve Biologics | Completed | No outcome recorded |
| Phase 41 trial · 1 missed | ||||||
| Phase 4 | NCT00288600 | Oct 2006 → Jun 2010 | fetal erythroblastosis, hyperbilirubinemia | Oswaldo Cruz Foundation | Completed | Missed primary |
| Phase not applicable1 trial | ||||||
| — | NCT02885259 | Sep 2016 → Dec 2017 | multifocal motor neuropathy | UMC Utrecht | Unknown | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT04381858 Comparator | May → Nov 2020 | pneumonia | Centenario Hospital Miguel Hidalgo | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2023-09-07 | Biotest | Regulatory US Food and Drug Administration FDA akzeptiert den Zulassungsantrag für Immunglobulin Yimmugo biotest.com ↗ |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2023-09-07 | Biotest | US Food and Drug Administration FDA akzeptiert den Zulassungsantrag für Immunglobulin Yimmugo biotest.com ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Human immunoglobulin | “The study group will receive Human Immunoglobulin (Immunoglobulin® - 50mg/ml) with a dose of 500mg/kg, equivalent to 10ml/kg during the initial 6hours of life, through...” NCT00288600 ↗ |
| Known as | IGIV | “intravenous immunoglobulin administration (IGIV) in patients developing ARDS post-SARS-CoV2.” NCT04350580 ↗ |
| Known as | IVIG | “The purpose of this study was to evaluate the efficacy of intravenous human immunoglobulin (IVIG) in the presence of high-intensity phototherapy in decreasing the need for...” PMID 22882285 ↗ Aug 2012 |
| Modality | Protein / enzyme biologic | “Nonspecific human immunoglobulin was not effective in preventing the need for exchange transfusion in neonates with rhesus hemolytic disease.” PMID 22882285 ↗ Aug 2012 |
| Route | Intravenous | “through intravenous infusion for 2 hours” NCT00288600 ↗ |