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Gammaplex 10
Gammaplex 10 is a Intravenous immunoglobulin (IVIG) Biologic drug developed by Bio Products Laboratory. It is currently in Phase 3 development for Primary immunodeficiency disorders, Secondary immunodeficiency in hematologic malignancies, Autoimmune and inflammatory conditions (e.g., immune thrombocytopenia, chronic inflammatory demyelinating polyneuropathy).
Gammaplex 10 is an intravenous immunoglobulin (IVIG) preparation that provides passive immunity by delivering pooled human antibodies to modulate immune function and replace deficient immunoglobulins.
Gammaplex 10 is a small molecule drug that inhibits tubulin, classified as an inhibitor. It has been studied in various clinical trials for conditions such as Chronic Hepatitis B, CIDP, MMN, Primary Immunodeficiency, and Stiff Person Syndrome, among others.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% 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 | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | Gammaplex 10 |
|---|---|
| Sponsor | Bio Products Laboratory |
| Drug class | Intravenous immunoglobulin (IVIG) |
| Target | Fc receptors; pathogenic antibodies and antigens (non-specific) |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
As an IVIG product, Gammaplex 10 contains polyvalent human immunoglobulins (primarily IgG) derived from pooled plasma of multiple donors. It works through multiple mechanisms including antibody replacement in immunodeficiency states, immune modulation via Fc receptor engagement, and neutralization of pathogenic antibodies and antigens. The preparation is used to restore or enhance immune function in patients with deficient or dysfunctional antibody responses.
Approved indications
- Primary immunodeficiency disorders
- Secondary immunodeficiency in hematologic malignancies
- Autoimmune and inflammatory conditions (e.g., immune thrombocytopenia, chronic inflammatory demyelinating polyneuropathy)
Common side effects
- Headache
- Fever
- Chills
- Myalgia
- Infusion reactions
- Thrombosis (rare)
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)
- Therapies for Down Syndrome Regression Disorder (PHASE2)
- Stem Cell Transplantation in Crohn's Disease (PHASE1, PHASE2)
- A Study About How TAK-881 is Processed by the Body and Side Effects in People With Primary Immunodeficiency Diseases (PHASE2, PHASE3)
- IVIG for Infection Prevention After CAR-T-Cell Therapy (PHASE2)
- A Study to Compare TAK-881 and HYQVIA in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (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:
- Gammaplex 10 CI brief — competitive landscape report
- Gammaplex 10 updates RSS · CI watch RSS
- Bio Products Laboratory portfolio CI
Frequently asked questions about Gammaplex 10
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Related
- Drug class: All Intravenous immunoglobulin (IVIG) drugs
- Target: All drugs targeting Fc receptors; pathogenic antibodies and antigens (non-specific)
- Manufacturer: Bio Products Laboratory — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Primary immunodeficiency disorders
- Indication: Drugs for Secondary immunodeficiency in hematologic malignancies
- Indication: Drugs for Autoimmune and inflammatory conditions (e.g., immune thrombocytopenia, chronic inflammatory demyelinating polyneuropathy)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing