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Immunoglobulin perfusion
Immunoglobulin perfusion is a Immunoglobulin therapy Small molecule drug developed by Centre Hospitalier Universitaire de Saint Etienne. It is currently in Phase 3 development for Investigational indication in phase 3 (specific indication not publicly detailed).
Immunoglobulin perfusion delivers immunoglobulins directly to affected tissues via regional perfusion to enhance local immune response and antibody concentration.
Immunoglobulin perfusion delivers immunoglobulins directly to affected tissues via regional perfusion to enhance local immune response and antibody concentration. Used for Investigational indication in phase 3 (specific indication not publicly detailed).
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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 | Immunoglobulin perfusion |
|---|---|
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne |
| Drug class | Immunoglobulin therapy |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
This approach uses regional perfusion techniques to deliver immunoglobulins (antibodies) at high concentrations directly to target tissues, bypassing systemic circulation limitations. By achieving elevated local antibody levels, the therapy aims to enhance immune-mediated destruction of pathological cells or pathogens while potentially reducing systemic exposure and adverse effects.
Approved indications
- Investigational indication in phase 3 (specific indication not publicly detailed)
Common side effects
- Infusion-related reactions
- Local tissue reactions at perfusion site
- Hypersensitivity reactions
Key clinical trials
- Paclitaxel and Carboplatin With or Without Bevacizumab in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer (PHASE3)
- Hepzato Kit and Opdualag for Metastatic Melanoma and Liver Metastasis (PHASE1, PHASE2)
- Safety and Efficacy of Faricimab in Patients With NPDR (PHASE2)
- PHP and Immunotherapy in Metastasized UM (PHASE1, PHASE2)
- Intravenous Immunoglobulins for the Treatment of Primary Sjögren's Syndrome Associated Painful Sensory Neuropathies (PHASE3)
- Evaluation of 200 mg of Rituximab Every 6 Months as Maintenance Treatment of Rituximab-treated Patients With Rheumatoid Arthritis (PHASE4)
- TACE Plus Bevacizumab for Hepatocellular Carcinoma With Portal Vein Invasion (NA)
- Isolated Hepatic Perfusion in Combination With Ipilimumab and Nivolumab in Patients With Uveal Melanoma Metastases (PHASE1)
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:
- Immunoglobulin perfusion CI brief — competitive landscape report
- Immunoglobulin perfusion updates RSS · CI watch RSS
- Centre Hospitalier Universitaire de Saint Etienne portfolio CI
Frequently asked questions about Immunoglobulin perfusion
What is Immunoglobulin perfusion?
How does Immunoglobulin perfusion work?
What is Immunoglobulin perfusion used for?
Who makes Immunoglobulin perfusion?
What drug class is Immunoglobulin perfusion in?
What development phase is Immunoglobulin perfusion in?
What are the side effects of Immunoglobulin perfusion?
Related
- Drug class: All Immunoglobulin therapy drugs
- Manufacturer: Centre Hospitalier Universitaire de Saint Etienne — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Investigational indication in phase 3 (specific indication not publicly detailed)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing