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IVIG-PEG
IVIG-PEG is a polyethylene glycol-conjugated intravenous immunoglobulin that provides passive immune protection by delivering pooled human antibodies with extended half-life.
IVIG-PEG is a polyethylene glycol-conjugated intravenous immunoglobulin that provides passive immune protection by delivering pooled human antibodies with extended half-life. Used for Primary immunodeficiency disorders, Secondary immunodeficiency conditions.
At a glance
| Generic name | IVIG-PEG |
|---|---|
| Sponsor | Grifols Therapeutics LLC |
| Drug class | Immunoglobulin replacement therapy |
| Target | Fc receptors and complement system (via pooled human IgG) |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
IVIG-PEG combines standard intravenous immunoglobulin (IVIG) with polyethylene glycol (PEG) conjugation to prolong circulating half-life and reduce dosing frequency. The PEG modification allows for less frequent administration while maintaining therapeutic antibody levels. This approach is intended to improve patient convenience and compliance in immunodeficiency and autoimmune conditions.
Approved indications
- Primary immunodeficiency disorders
- Secondary immunodeficiency conditions
Common side effects
- Infusion reactions
- Headache
- Fever
- Myalgia
- Thrombotic events
Key clinical trials
- Clinical Study of TA-650 in Patients With Refractory Kawasaki Disease (PHASE3)
- A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Immune Globulin (Human) 10% (Gamunex-C) PEG Process (IVIG-PEG) Compared to Gamunex-C in Participants With Primary Humoral Immunodeficiency (PHASE3)
- IVIG - West Nile Encephalitis: Safety and Efficacy (PHASE1, PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- IVIG-PEG CI brief — competitive landscape report
- IVIG-PEG updates RSS · CI watch RSS
- Grifols Therapeutics LLC portfolio CI