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IV Gamunex 10%
IV Gamunex 10% is a Immunoglobulin Small molecule drug developed by The Center for Rheumatic Disease, Allergy, & Immunology. It is currently in Phase 2 development for Primary immunodeficiency, Chronic inflammatory demyelinating polyneuropathy, Multifocal motor neuropathy.
Immunomodulation through the administration of intravenous immunoglobulin
Gamunex 10% is a licensed human normal immunoglobulin used for IV infusion to treat various conditions, including diabetes complications and diabetic neuropathies. It is not a small molecule, but rather a type of immunoglobulin.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | IV Gamunex 10% |
|---|---|
| Sponsor | The Center for Rheumatic Disease, Allergy, & Immunology |
| Drug class | Immunoglobulin |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 2 |
Mechanism of action
Gamunex 10% is a solution of 10% human immunoglobulin G (IgG) used to treat various immune system disorders.
Approved indications
- Primary immunodeficiency
- Chronic inflammatory demyelinating polyneuropathy
- Multifocal motor neuropathy
Common side effects
- Headache
- Fatigue
- Nausea
Key clinical trials
- A Study of Gammagard Liquid (Immune Globulin Infusion, 10%) to Prevent Infections in Adults With Multiple Myeloma (PHASE3)
- A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation (PHASE2)
- A Study Investigating Intravenous Human Normal Immune Globulin (IGIV) 10% in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) (PHASE3)
- Stem Cell Transplantation in Crohn's Disease (PHASE1, PHASE2)
- IVIG for Infection Prevention After CAR-T-Cell Therapy (PHASE2)
- V-IMMUNE: A Novel Immunoglobulin Therapy for Immunodeficiency (PHASE3)
- The Effect and Safety Profile of Thymoglobulin® in Primary Cardiac Transplant Recipients (PHASE2)
- Total Body Irradiation and Astatine-211-Labeled BC8-B10 Monoclonal Antibody for the Treatment of Nonmalignant Diseases (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:
- IV Gamunex 10% CI brief — competitive landscape report
- IV Gamunex 10% updates RSS · CI watch RSS
- The Center for Rheumatic Disease, Allergy, & Immunology portfolio CI
Frequently asked questions about IV Gamunex 10%
What is IV Gamunex 10%?
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Related
- Drug class: All Immunoglobulin drugs
- Manufacturer: The Center for Rheumatic Disease, Allergy, & Immunology — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Primary immunodeficiency
- Indication: Drugs for Chronic inflammatory demyelinating polyneuropathy
- Indication: Drugs for Multifocal motor neuropathy
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing