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IgPro20
IgPro20 is a subcutaneous immunoglobulin replacement therapy that provides passive immunity by delivering polyclonal human immunoglobulins to patients with primary immunodeficiency.
IgPro20 is a subcutaneous immunoglobulin replacement therapy that provides passive immunity by delivering polyclonal human immunoglobulins to patients with primary immunodeficiency. Used for Primary immunodeficiency disorders requiring immunoglobulin replacement therapy, Secondary immunodeficiency in patients with recurrent infections.
At a glance
| Generic name | IgPro20 |
|---|---|
| Also known as | IgG with Proline, IgG with Proline (IgPro), Hizentra, HIZENTRA®, HIZENTRA |
| Sponsor | CSL Behring |
| Drug class | Immunoglobulin replacement therapy |
| Target | Polyclonal IgG (multiple epitopes) |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Mechanism of action
IgPro20 is a 20% liquid immunoglobulin G (IgG) preparation derived from pooled human plasma that replaces deficient or dysfunctional antibodies in patients with primary immunodeficiency disorders. It is administered subcutaneously to maintain adequate immunoglobulin levels and reduce the frequency and severity of infections. The high concentration (20%) allows for smaller injection volumes compared to lower-concentration formulations.
Approved indications
- Primary immunodeficiency disorders requiring immunoglobulin replacement therapy
- Secondary immunodeficiency in patients with recurrent infections
Common side effects
- Injection site reactions (pain, erythema, swelling)
- Headache
- Fatigue
- Fever
- Nausea
Key clinical trials
- Study of IgPro20 to Prevent Infection in People With Multiple Myeloma and Hypogammaglobulinemia (PHASE2)
- An Open-label, Multicenter Study to Assess the Pharmacokinetics (PK), Safety, and Tolerability of Subcutaneous IgPro20 in Immunoglobulin (IG) Treatment-naïve Participants With Primary Immunodeficiency (PID) (PHASE4)
- A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM) (PHASE3)
- Double-blind, Randomized, Placebo-controlled Study Evaluating Efficacy and Safety of IgPro20 in Post-COVID-19 POTS (PHASE3)
- Hizentra® in Inflammatory Neuropathies - pHeNIx Study
- Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults With Systemic Sclerosis (SSc) (PHASE2)
- Safety and Tolerability of Higher Infusion Parameters of IgPro20 (Hizentra) in Subjects With Primary Immunodeficiency (PID) (PHASE4)
- Extension Study of Maintenance Treatment With Subcutaneous Immunoglobulin (IgPro20) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) (PHASE3)
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:
- IgPro20 CI brief — competitive landscape report
- IgPro20 updates RSS · CI watch RSS
- CSL Behring portfolio CI