Overview
Berotralstat is a selective inhibitor of plasma kallikrein used in the prophylaxis of attacks of hereditary angioedema (HAE). It works by blocking the enzymatic activity of plasma kallikrein in releasing bradykinin, the major biologic peptide that promotes swelling and pain associated with attacks of HAE. Berotralstat is strictly used to prevent, but not treat, these attacks. Developed by BioCryst Pharmaceuticals, berotralstat is marketed under the name Orladeyo as oral capsules. Berotralstat was first approved by the FDA on December 3, 2020, as the first once-daily oral therapy to prevent angioedema attacks of HAE in adults and pediatric patients 12 years and older. Berotralstat was approved by the European Commission on April 30, 2021 and by Health Canada on June 06, 2022.
Indication
Berotralstat is indicated for prophylaxis of attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older. It is not used for the treatment of acute HAE attacks.
Associated Conditions
- Acute attacks of hereditary angioedema
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/07/12 | Phase 3 | Active, not recruiting | |||
2021/06/22 | Phase 3 | Active, not recruiting | |||
2020/06/11 | N/A | APPROVED_FOR_MARKETING | |||
2019/03/13 | Phase 3 | Completed | |||
2018/04/03 | Phase 3 | Completed | |||
2018/03/21 | Phase 2 | Completed | |||
2017/08/04 | Phase 2 | Completed | |||
2017/06/29 | Phase 1 | Completed | |||
2017/05/02 | Phase 1 | Completed | |||
2016/08/18 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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