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Immunoglobulins
Immunoglobulins is a Small molecule drug developed by Rigshospitalet, Denmark. It is currently in Phase 3 development. Also known as: Gammanorm(R), immunoglobulin for subcutaneous use, Immunoglobulins in this study uses commercially avilable drug..
Immunoglobulins, also known as antibodies, are large proteins used by the immune system to identify and neutralize specific antigens, such as those on bacteria and virus cells. They are found in bovine colostrum, which contains protective antibodies, and are used to treat various conditions, including autoimmune diseases, gastric cancer, breast cancer, and anti-NMDAR encephalitis.
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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 | Immunoglobulins |
|---|---|
| Also known as | Gammanorm(R), immunoglobulin for subcutaneous use, Immunoglobulins in this study uses commercially avilable drug. |
| Sponsor | Rigshospitalet, Denmark |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- A Phase 1 Study of IM-1021 in Participants With Advanced Cancer (PHASE1)
- Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer (PHASE2)
- Durvalumab in Combination With Chemotherapy in Treating Patients With Advanced Solid Tumors, DURVA+ Trial (PHASE2)
- Nivolumab in Treating Patients With Localized Kidney Cancer Undergoing Nephrectomy (PHASE3)
- Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma (PHASE3)
- Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma (PHASE3)
- 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)
- Descartes-08 for Patients With Systemic Lupus Erythematosus (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:
- Immunoglobulins CI brief — competitive landscape report
- Immunoglobulins updates RSS · CI watch RSS
- Rigshospitalet, Denmark portfolio CI
Frequently asked questions about Immunoglobulins
What is Immunoglobulins?
Who makes Immunoglobulins?
Is Immunoglobulins also known as anything else?
What development phase is Immunoglobulins in?
Related
- Manufacturer: Rigshospitalet, Denmark — full pipeline
- Therapeutic area: All drugs in Immunology
- Also known as: Gammanorm(R), immunoglobulin for subcutaneous use, Immunoglobulins in this study uses commercially avilable drug.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing