Berotralstat
Orphan DrugFDA Approved
Contents
Description
Berotralstat is a plasma kallikrein inhibitor used for prophylactic treatment to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years and older. It works by decreasing the activity of plasma kallikrein, an enzyme involved in the HAE pathway.
Indications & Therapeutic Use
Hereditary Angioedema
Global Availability (4 countries)
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Available Through
This drug is available for procurement through the following fulfilment partner.
Fulfilment Partner
Berotralstat
| Generic Name | Berotralstat |
| Brands | 1 brand available |
| Active Ingredient | Berotralstat |
| Drug Class | Hereditary Angioedema |
| Manufacturer | BioCryst Pharmaceuticals |
| Dosage Forms | Capsule |
| Medical Code | C09BB16 |
| Orphan Status | Yes — Orphan Drug |
| Cold Chain | Not Required |
| Lead Time | 14 days |
| Reg. Status | FDA Approved |
| Clinical Trial | NCT02586805 |
| Countries | 4 countries |
Authority Signals
Last Verified3/21/2026
Data ConfidenceHigh (AI + Pharmacist)
Source Citations5 Validated Nodes