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gammaglobulin
gammaglobulin is a Biologic drug developed by Federal University of São Paulo. It is currently in Phase 1 development. Also known as: Beriglobin 17540311E.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | gammaglobulin |
|---|---|
| Also known as | Beriglobin 17540311E |
| Sponsor | Federal University of São Paulo |
| Modality | Biologic |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Intravenous Gammaglobulin for Sickle Cell Pain Crises (PHASE1, PHASE2)
- Usage of Spirometry in Managing IgG Therapy in CVID with Airway Disease (PHASE4)
- Cyclophosphamide and Prednisone With or Without Immunoglobulin in Treating Abnormal Muscle Movement in Children With Neuroblastoma (PHASE3)
- The Effect of Eltrombopag on the Expression of Platelet Collagen Receptor GPVI in Pediatric ITP. (NA)
- Safety, Pharmacokinetic and Efficacy Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Patients With Primary Immunodeficiency (Hypo- or Agammaglobulinemia) (PHASE2)
- Antibodies Production After Covid-19 Vaccination Among Patients With Medical History of Cancer and Anti-CD-20 Treatment
- Pilot Study of Etoposide-based Therapy and Hematopoietic Cell Transplantation for Hemophagocytic Lymphohistiocytosis (NA)
- Efficacy of Intravenous Immunoglobulin in Management of Rh and ABO Incompatibility Disease (EARLY_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:
- gammaglobulin CI brief — competitive landscape report
- gammaglobulin updates RSS · CI watch RSS
- Federal University of São Paulo portfolio CI
Frequently asked questions about gammaglobulin
What is gammaglobulin?
Who makes gammaglobulin?
Is gammaglobulin also known as anything else?
What development phase is gammaglobulin in?
Related
- Manufacturer: Federal University of São Paulo — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Beriglobin 17540311E
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing