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Low-volume C1-esterase inhibitor
Low-volume C1-esterase inhibitor (C1-INH) replaces or augments deficient or dysfunctional C1-esterase inhibitor protein to suppress excessive contact system and complement activation.
Low-volume C1-esterase inhibitor (C1-INH) replaces or augments deficient or dysfunctional C1-esterase inhibitor protein to suppress excessive contact system and complement activation. Used for Hereditary angioedema (HAE) with C1-INH deficiency or dysfunction, Acute angioedema attacks in HAE patients.
At a glance
| Generic name | Low-volume C1-esterase inhibitor |
|---|---|
| Sponsor | CSL Behring |
| Drug class | Serine protease inhibitor / Complement regulator |
| Target | C1-esterase inhibitor (C1-INH protein) |
| Modality | Biologic |
| Therapeutic area | Immunology / Rare disease |
| Phase | Phase 3 |
Mechanism of action
C1-esterase inhibitor is a serine protease inhibitor that regulates the contact system (kallikrein-kinin pathway) and classical complement pathway. Deficiency or dysfunction of C1-INH leads to uncontrolled bradykinin generation and complement activation, causing angioedema and other inflammatory manifestations. This low-volume formulation provides C1-INH replacement therapy to restore normal regulation of these pathways.
Approved indications
- Hereditary angioedema (HAE) with C1-INH deficiency or dysfunction
- Acute angioedema attacks in HAE patients
Common side effects
- Thrombosis / thromboembolic events
- Hypersensitivity reactions
- Injection site reactions
- Headache
Key clinical trials
- A Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema (PHASE3)
- A Study to Evaluate the Long-term Clinical Safety and Efficacy of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema (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:
- Low-volume C1-esterase inhibitor CI brief — competitive landscape report
- Low-volume C1-esterase inhibitor updates RSS · CI watch RSS
- CSL Behring portfolio CI