Drug profile · INN
berotralstat dihydrochloride
ORLADEYO
berotralstat dihydrochloride (ORLADEYO) is a plasma kallikrein inhibitor. Associated with Biocryst. Route of administration: oral. Current US regulatory status: approved.
Drug details — berotralstat dihydrochloride
- US status
- approved
- Class
- —
- Route
- ORAL
- Patents
- 20
- Programs
- 1
- Data quality
- 0.89
Quick answer
berotralstat dihydrochloride (ORLADEYO) is a plasma kallikrein inhibitor. Associated with Biocryst. Route of administration: oral. Current US regulatory status: approved.
Key facts
Mechanism of action
Plasma kallikrein inhibitor
Primary target: Plasma kallikrein
Approval history
| Authority | Status | Date |
|---|---|---|
| FDA | 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
Related patents
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US 12344585
Crystalline salts of a plasma kallikrein inhibitor
granted -
US 12116346
Human plasma kallikrein inhibitors
granted -
US 11708333
Human plasma kallikrein inhibitors
granted -
US 11618733
Crystalline salts of a plasma kallikrein inhibitor
granted -
US 11559515
Indole compounds and analogues thereof
granted -
US 11230530
Human plasma kallikrein inhibitors
granted -
US 11173159
Methods and compositions for inhibition of polymerase
granted -
US 11117867
Crystalline salts of a plasma kallikrein inhibitor
granted -
US 10849883
Benzopyrazole compounds and analogues thereof
granted -
US 10689346
Human plasma kallikrein inhibitors
granted -
US 10662160
Crystalline salts of a plasma kallikrein inhibitor
granted -
US 10420769
Methods and compositions for inhibition of polymerase
granted -
US 10329260
Human plasma kallikrein inhibitors
granted -
US 10125102
Human plasma kallikrein inhibitors
granted -
US 10022375
Methods and compositions for inhibition of polymerase
granted -
US 9580428
Compositions and methods for inhibiting viral polymerase
granted -
US 9492452
Methods and compositions for inhibition of polymerase
granted -
US 8163703
Hepatitis C therapies
granted -
US 8133870
Therapeutic furopyrimidines and thienopyrimidines
granted -
US 7514410
Hepatitis C therapies
granted
Frequently asked questions
What is berotralstat dihydrochloride?
berotralstat dihydrochloride (ORLADEYO) is a plasma kallikrein inhibitor. Associated with Biocryst. Route of administration: oral. Current US regulatory status: approved.
What is the brand name for berotralstat dihydrochloride?
ORLADEYO is a marketed brand name for berotralstat dihydrochloride. Check FDA Drugs@FDA for the current US label holder and prescribing information.
What is the US approval status of berotralstat dihydrochloride?
berotralstat dihydrochloride has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.