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Subcuvia
Subcuvia is a Small molecule drug developed by Johannes Jakobsen. It is currently in Phase 2 development. Also known as: Human immunoglobulin.
Subcuvia is used to treat various conditions, including Multifocal Motor Neuropathy, Chronic Inflammatory Demyelinating Polyneuropathy, and Primary Immunodeficiency Diseases. It is administered as a subcutaneous immunoglobulin, which is a type of immunoglobulin intervention.
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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).
| 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 | Subcuvia |
|---|---|
| Also known as | Human immunoglobulin |
| Sponsor | Johannes Jakobsen |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Immune Globulin Subcutaenous (Human), 20% (PHASE2, PHASE3)
- Efficacy and Safety of HyQvia (Immunoglobulin 10% With Recombinant Hyaluronidase) in Multifocal Motor Neuropathy (MMN) (PHASE2)
- Immunoglobulin Dosage and Administration Form in CIDP and MMN
- Subcutaneous Immunoglobulin Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) (PHASE2)
- Subcutaneous Immunoglobulin Treatment for Multifocal Motor Neuropathy (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:
- Subcuvia CI brief — competitive landscape report
- Subcuvia updates RSS · CI watch RSS
- Johannes Jakobsen portfolio CI
Frequently asked questions about Subcuvia
What is Subcuvia?
Who makes Subcuvia?
Is Subcuvia also known as anything else?
What development phase is Subcuvia in?
Related
- Manufacturer: Johannes Jakobsen — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Human immunoglobulin
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing