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IgNextGen 16%
IgNextGen 16% is an intravenous immunoglobulin (IVIG) product that provides passive immunization by delivering pooled human antibodies to modulate immune function and replace deficient immunoglobulins.
IgNextGen 16% is an intravenous immunoglobulin (IVIG) product that provides passive immunization by delivering pooled human antibodies to modulate immune function and replace deficient immunoglobulins. Used for Primary immunodeficiency disorders, Secondary immunodeficiency, Autoimmune and inflammatory conditions.
At a glance
| Generic name | IgNextGen 16% |
|---|---|
| Sponsor | CSL Limited |
| Drug class | Intravenous immunoglobulin (IVIG) |
| Target | Fc receptors, complement system, pathogenic antigens |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
As a 16% concentration IVIG, this product contains immunoglobulins (primarily IgG) derived from pooled human plasma. It works by providing immediate passive immunity, neutralizing pathogens and toxins, modulating inflammatory responses through Fc receptor engagement, and supporting patients with immunodeficiency or autoimmune conditions. The higher 16% concentration allows for smaller infusion volumes compared to standard IVIG formulations.
Approved indications
- Primary immunodeficiency disorders
- Secondary immunodeficiency
- Autoimmune and inflammatory conditions
Common side effects
- Headache
- Fever
- Chills
- Infusion site reactions
- Thromboembolism
- Renal dysfunction
Key clinical trials
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:
- IgNextGen 16% CI brief — competitive landscape report
- IgNextGen 16% updates RSS · CI watch RSS
- CSL Limited portfolio CI