This brand name is authorized in United States. It is also authorized in Austria, Estonia, Italy, Lithuania.
The drug EKTERLY contains one active pharmaceutical ingredient (API):
1
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UNII
O5ZD2TU2B7 - SEBETRALSTAT
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Sebetralstat is a competitive, reversible inhibitor of plasma kallikrein (PKa). By inhibiting PKa, sebetralstat blocks the cleavage of high molecular weight kininogen (HK) and the subsequent generation of bradykinin (BK), thereby halting HAE attack progression which is associated with increased vascular permeability and oedema formation. Sebetralstat also suppresses the activation of positive feedback mechanism of the kallikrein-kinin system (KKS), thereby reducing factor XIIa (FXIIa) and additional PKa production. |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| EKTERLY Film-coated tablet | MPI, EU: SmPC | European Medicines Agency (EU) | |
| EKTERLY Film-coated tablet | MPI, US: SPL/PLR | FDA, National Drug Code (US) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| B06AC08 | B Blood and blood forming organs → B06 Other hematological agents → B06A Other hematological agents → B06AC Drugs used in hereditary angioedema | |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| EE | Ravimiamet | 3131817, 3131828 |
| IT | Agenzia del Farmaco | 052563018, 052563020 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1104928, 1104929 |
| US | FDA, National Drug Code | 82928-300 |
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