Drug profile · INN
berotralstat hydrochloride
ORLADEYO
berotralstat hydrochloride (ORLADEYO) is a plasma kallikrein inhibitor.
Drug details — berotralstat hydrochloride
- Class
- —
- Route
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- Patents
- 0
- Programs
- 1
- Data quality
- 0.78
Quick answer
berotralstat hydrochloride (ORLADEYO) is a plasma kallikrein inhibitor.
Key facts
Mechanism of action
Plasma kallikrein inhibitor
Primary target: Plasma kallikrein
Approval history
| Authority | Status | Date |
|---|---|---|
| PMDA | approved | — |
Recent coverage
BioCryst’s New ORLADEYO Data Adds Real-World HAE Evidence
BioCryst Pharmaceuticals is presenting new clinical data and real-world evidence for ORLADEYO (berotralstat) in hereditary angioedema. The update matters because it expands the evidence base around an FDA-approved oral prophylactic option for adults and pediatric patients 2 years and older.
BioCryst Presents New HAE Data for ORLADEYO® and Navenibart at EAACI 2026
BioCryst Pharmaceuticals will present new hereditary angioedema (HAE) data for its oral therapy ORLADEYO® (berotralstat) and its investigational therapy navenibart at the 2026 European Academy of Allergy and Clinical Immunology (EAACI) Annual Meeting. This presentation highlights BioCryst's ongoing commitment to advancing HAE treatment and understanding.
Pipeline programs
Related & competitor drugs
Frequently asked questions
What is berotralstat hydrochloride?
berotralstat hydrochloride (ORLADEYO) is a plasma kallikrein inhibitor.
What is the brand name for berotralstat hydrochloride?
ORLADEYO is a marketed brand name for berotralstat hydrochloride. Check FDA Drugs@FDA for the current US label holder and prescribing information.