Garadacimab
Orphan Drug Cold Chain RequiredFDA Approved (2025)
Description
A factor XIIa-inhibiting monoclonal antibody for once-monthly prophylaxis of hereditary angioedema attacks. FDA-approved 2025.
Indications & Therapeutic Use
Hereditary angioedema (prophylaxis)
Linked Diseases:
Global Availability (1 countries)
| Country | Access Route | Regulatory Pathway | Lead Time | Status |
|---|---|---|---|---|
| Standard Marketing Authorization | — | — | Approved |
Available Through
This drug is available for procurement through the following fulfilment partner.
Fulfilment Partner
Garadacimab
| Generic Name | garadacimab |
| Brands | 1 brand available |
| Active Ingredient | garadacimab |
| Drug Class | Hereditary angioedema (prophylaxis) |
| Manufacturer | CSL Behring |
| Orphan Status | Yes — Orphan Drug |
| Cold Chain | Required |
| Reg. Status | FDA Approved (2025) |
| Countries | 1 countries |
Authority Signals
Last Verified7/24/2026
Data ConfidenceHigh (AI + Pharmacist)
Source Citations2 Validated Nodes