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IGSC 20%
IGSC 20% is a Biologic drug developed by Grifols Therapeutics LLC. It is currently FDA-approved. Also known as: Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography, Immune Globulin Subcutaneous 20% Caprylate/Chromatography, Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified.
IGSC 20% is a marketed product by Grifols Therapeutics LLC, positioned in the immunoglobulin therapy market. The drug's key strength lies in its composition, protected by a patent expiring in 2028. The primary risk is the eventual loss of patent protection, which could lead to increased competition from generic alternatives.
At a glance
| Generic name | IGSC 20% |
|---|---|
| Also known as | Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography, Immune Globulin Subcutaneous 20% Caprylate/Chromatography, Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified |
| Sponsor | Grifols Therapeutics LLC |
| Modality | Biologic |
| Phase | FDA-approved |
Approved indications
Common side effects
Key clinical trials
- A Study to Evaluate Efficacy, Safety, and PK of XEMBIFY®+Standard Medical Treatment (SMT) Compared to Placebo+SMT to Prevent Infections in Participants With HGG and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma (PHASE3)
- An Extension Study of TAK-664 for Japanese People With Primary Immunodeficiency Disease (PHASE3)
- A Study of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) in Japanese Participants With Primary Immunodeficiency Diseases (PID) (PHASE3)
- A Study of TAK-881 in Healthy Adults (PHASE1)
- A Study to Evaluate IGSC 20% Biweekly Dosing in Treatment-Experienced Participants and Loading/Maintenance Dosing in Treatment-Naïve Participants With Primary Immunodeficiency (PHASE4)
- Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric PIDD Subjects (PHASE4)
- Phase 2/3 Study of IGSC, 20% in PIDD (PHASE2, PHASE3)
- Immune Globulin Subcutaenous (Human), 20% (PHASE2, 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:
- IGSC 20% CI brief — competitive landscape report
- IGSC 20% updates RSS · CI watch RSS
- Grifols Therapeutics LLC portfolio CI
Frequently asked questions about IGSC 20%
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Related
- Manufacturer: Grifols Therapeutics LLC — full pipeline
- Also known as: Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography, Immune Globulin Subcutaneous 20% Caprylate/Chromatography, Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing