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CINRYZE 500
CINRYZE is a C1 esterase inhibitor (C1-INH) that suppresses activation of the contact system to prevent bradykinin-mediated angioedema attacks.
CINRYZE is a C1 esterase inhibitor (C1-INH) that suppresses activation of the contact system to prevent bradykinin-mediated angioedema attacks. Used for Hereditary angioedema (HAE) Types I and II — acute attack treatment and prophylaxis.
At a glance
| Generic name | CINRYZE 500 |
|---|---|
| Sponsor | Shire |
| Drug class | C1 esterase inhibitor (C1-INH) replacement therapy |
| Target | C1 esterase inhibitor (C1-INH); contact system/kallikrein-kinin pathway |
| Modality | Biologic |
| Therapeutic area | Immunology / Rare Genetic Disorders |
| Phase | Phase 3 |
Mechanism of action
CINRYZE replaces or augments deficient or dysfunctional C1 esterase inhibitor protein, which normally regulates the intrinsic coagulation cascade and contact system. By restoring C1-INH activity, the drug prevents excessive bradykinin generation, thereby reducing the frequency and severity of acute angioedema episodes in hereditary angioedema (HAE) patients.
Approved indications
- Hereditary angioedema (HAE) Types I and II — acute attack treatment and prophylaxis
Common side effects
- Headache
- Nausea
- Infusion site reactions
- Thrombotic events (rare)
Key clinical trials
- Berinert (C1INH) vs Placebo for DGF/IRI (PHASE1, PHASE2)
- Evaluation of the Effects of Bradykinin Antagonists on Pulmonary Manifestations of COVID-19 Infections (AntagoBrad-Cov Study). (PHASE2)
- Safety and Efficacy Study of CINRYZE for Prevention of Angioedema Attacks in Children Ages 6-11 With Hereditary Angioedema (PHASE3)
- CINRYZE for the Treatment of Hereditary Angioedema Attacks in Children Under the Age of 12 (PHASE2)
- Study of C1 Inhibitor (Human) for the Prevention of Angioedema Attacks and Treatment of Breakthrough Attacks in Japanese Subjects With Hereditary Angioedema (HAE) (PHASE3)
- Postmarketing Immunogenicity Study in HAE Subjects Treated With Berinert (PHASE4)
- C1 Esterase Inhibitor in Hereditary Angioedema (HAE)(Extension Study) (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:
- CINRYZE 500 CI brief — competitive landscape report
- CINRYZE 500 updates RSS · CI watch RSS
- Shire portfolio CI