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GB-0998
GB-0998 is a recombinant human C1-inhibitor that regulates complement and contact system activation to prevent hereditary angioedema attacks.
GB-0998 is a recombinant human C1-inhibitor that regulates complement and contact system activation to prevent hereditary angioedema attacks. Used for Hereditary angioedema (HAE) prophylaxis.
At a glance
| Generic name | GB-0998 |
|---|---|
| Also known as | Intravenous immunoglobulin (Venoglobulin IH), Venoglobulin-IH, High-dose intravenous immunoglobulin, Intravenous Immunoglobulin （Venoglobulin®IH，2.5g/50ml） |
| Sponsor | Japan Blood Products Organization |
| Drug class | Recombinant C1-inhibitor replacement therapy |
| Target | C1-inhibitor (C1-INH) |
| Modality | Small molecule |
| Therapeutic area | Immunology / Rare Disease |
| Phase | Phase 3 |
Mechanism of action
GB-0998 replaces or augments deficient or dysfunctional C1-inhibitor protein, which normally suppresses excessive activation of the complement cascade and bradykinin-generating contact system. By restoring C1-inhibitor function, the drug reduces uncontrolled vascular permeability and inflammation that characterize hereditary angioedema (HAE), thereby preventing acute angioedema episodes.
Approved indications
- Hereditary angioedema (HAE) prophylaxis
Common side effects
- Infusion-related reactions
- Headache
- Thrombotic events
Key clinical trials
- A Study of the Efficacy and Safety of GB-0998 in Patients With Unexplained Recurrent Miscarriage (PHASE3)
- The Desensitization Therapy With GB-0998 for Anti-donor Antibody-positive Recipients. (PHASE2, PHASE3)
- Efficacy and Safety Study of GB-0998 for Guillain-Barré Syndrome (PHASE3)
- Efficacy and Safety Study of GB-0998 for Treatment of Steroid-resistant Polymyositis and Dermatomyositis (PM/DM) (PHASE3)
- Efficacy and Safety Study of GB-0998 for Treatment of Generalized Myasthenia Gravis (PHASE3)
- Efficacy and Safety Study of GB-0998 for Treatment of Systemic Sclerosis (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:
- GB-0998 CI brief — competitive landscape report
- GB-0998 updates RSS · CI watch RSS
- Japan Blood Products Organization portfolio CI