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Cuvitru 20 % Injectable Solution
Cuvitru is a human immunoglobulin (antibody) replacement therapy that provides passive immunity by supplying functional antibodies to patients with primary immunodeficiency.
Cuvitru is a human immunoglobulin (antibody) replacement therapy that provides passive immunity by supplying functional antibodies to patients with primary immunodeficiency. Used for Primary immunodeficiency disorders requiring immunoglobulin replacement, Secondary immunodeficiency in patients unable to produce adequate antibodies.
At a glance
| Generic name | Cuvitru 20 % Injectable Solution |
|---|---|
| Sponsor | University of Edinburgh |
| Drug class | Immunoglobulin replacement therapy |
| Target | Fc receptors and complement system (via IgG antibodies) |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Mechanism of action
Cuvitru is a subcutaneous immunoglobulin (SCIg) replacement therapy derived from pooled human plasma. It works by restoring deficient or dysfunctional antibodies in patients with primary immunodeficiency disorders, enabling them to mount appropriate immune responses against infections. The therapy provides immediate passive immunity and helps prevent recurrent bacterial and viral infections.
Approved indications
- Primary immunodeficiency disorders requiring immunoglobulin replacement
- Secondary immunodeficiency in patients unable to produce adequate antibodies
Common side effects
- Local injection site reactions (pain, erythema, swelling)
- Headache
- Fatigue
- Fever
- Nausea
- Thrombotic events
Key clinical trials
- The Efficacy Of Intravenous Immunoglobulin Therapy In Treatment Induced Neuropathy Of Diabetes (PHASE2)
- IVIg for Small Fiber Neuropathy With Autoantibodies TS-HDS and FGFR3 (PHASE2)
- Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric PIDD Subjects (PHASE4)
- Immunoglobulin Replacement Therapy for Immunoglobulin G Subclass 2 Deficient Patients With Bronchiectasis (PHASE4)
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:
- Cuvitru 20 % Injectable Solution CI brief — competitive landscape report
- Cuvitru 20 % Injectable Solution updates RSS · CI watch RSS
- University of Edinburgh portfolio CI