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Filsuvez (garadacimab)
Monoclonal antibody that inhibits activated Factor XII (FXIIa), preventing the generation of bradykinin which causes angioedema attacks.
At a glance
| Generic name | garadacimab |
|---|---|
| Also known as | CSL312, CSL312 |
| Sponsor | CSL Behring |
| Drug class | Anti-Factor XIIa monoclonal antibody |
| Target | Activated Factor XII (FXIIa) |
| Modality | Biologic |
| Therapeutic area | Hematology |
| Phase | FDA-approved |
Mechanism of action
Garadacimab is a fully human monoclonal antibody targeting activated coagulation Factor XII (FXIIa). In hereditary angioedema (HAE), uncontrolled activation of the contact activation system leads to excessive bradykinin production, causing recurrent episodes of severe tissue swelling. By inhibiting FXIIa at the top of the cascade, garadacimab blocks kallikrein activation and subsequent bradykinin generation, preventing HAE attacks. It represents a novel upstream approach compared to existing therapies that target downstream mediators.
Approved indications
- Epidermolysis bullosa
Common side effects
- Nasopharyngitis
- Abdominal Pain
- Injection Site Reactions
- Prolonged Prothrombin Time (PT/INR)
- Prolonged Activated Partial Thromboplastin Time (aPTT)
Key clinical trials
- A Phase 3 Open-label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema in Pediatric Subjects (Phase 3)
- Post Study Access of CSL312 (Garadacimab) for the Routine Prevention of Hereditary Angioedema (HAE) Attacks in Pediatric Participants (2-11 Years Old) With HAE Who Have Completed the CSL312_3003 Study (N/A)
- Double-blind, Randomised, Vehicle-controlled, Phase III, Efficacy and Safety Study With 24-month Open-label Follow-up of Oleogel-S10 in Patients With Inherited Epidermolysis Bullosa (Phase 3)
- A Phase 1b, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety, and Pharmacokinetics of CSL312 in the Prevention of Peripherally Inserted Central Cath (Phase 1)
- A Randomized, Double-blind, Placebo-controlled, Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of Garadacimab in Subjects With Idiopathic Pulmonary Fibrosis (Phase 2)
- A Long-term Non-interventional Study to Assess the Incidence of Skin Malignancies in Patients With Dystrophic and Junctional Epidermolysis Bullosa Receiving Treatment With Filsuvez (N/A)
- A Phase 4 Open-label Study to Evaluate the Safety After Switching to CSL312 (Garadacimab) From Current Prophylactic HAE Treatment in Subjects With HAE ≥ 12 Years of Age (Phase 4)
- A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-arm Study to Investigate the Efficacy and Safety of Subcutaneous Administration of CSL312 (Garadacimab) in the Prophylactic Treatm (Phase 3)
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:
- Filsuvez CI brief — competitive landscape report
- Filsuvez updates RSS · CI watch RSS
- CSL Behring portfolio CI