Last reviewed · How we verify
Higher-volume C1-esterase inhibitor
A higher-concentration formulation of C1-esterase inhibitor that suppresses activation of the contact system and complement cascade to prevent angioedema attacks.
A higher-concentration formulation of C1-esterase inhibitor that suppresses activation of the contact system and complement cascade to prevent angioedema attacks. Used for Hereditary angioedema (HAE) with C1-INH deficiency or dysfunction, Acute angioedema attacks in HAE patients.
At a glance
| Generic name | Higher-volume C1-esterase inhibitor |
|---|---|
| Sponsor | CSL Behring |
| Drug class | Serine protease inhibitor / Complement regulator |
| Target | C1-esterase (C1s), Factor XIIa, Plasma kallikrein |
| Modality | Biologic |
| Therapeutic area | Immunology / Rare Disease |
| Phase | Phase 3 |
Mechanism of action
C1-esterase inhibitor (C1-INH) is a serine protease inhibitor that regulates the initial steps of the contact system (Factor XII, kallikrein) and classical complement pathway. By inhibiting these cascades, it prevents excessive bradykinin generation and complement activation, which are responsible for increased vascular permeability and angioedema. The higher-volume formulation allows for increased dosing or less frequent administration compared to standard C1-INH products.
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
- Infection transmission risk (plasma-derived)
- Headache
Key clinical trials
- Berinert (C1INH) vs Placebo for DGF/IRI (PHASE1, PHASE2)
- A Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema (PHASE3)
- C1INH Inhibitor Preoperative and Post Kidney Transplant to Prevent DGF & IRI (PHASE1, PHASE2)
- Safety & Tolerability of Berinert® (C1 Inhibitor) Therapy to Prevent Rejection (PHASE1, 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:
- Higher-volume C1-esterase inhibitor CI brief — competitive landscape report
- Higher-volume C1-esterase inhibitor updates RSS · CI watch RSS
- CSL Behring portfolio CI