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sebetralstat 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| enzyme inhibitors | 5779 | None |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Sebetralstat is a competitive, reversible inhibitor of plasma kallikrein. Plasma kallikrein is a serine protease that cleaves high molecular weight kininogen (HK) releasing bradykinin which increases vascular permeability through activation of bradykinin receptors causing edema. Sebetralstat inhibits the cleavage of HK and reduces production of bradykinin, thereby treating the clinical symptoms of an acute, episodic attack of HAE. Sebetralstat also inhibits the positive feedback mechanism of the kallikrein kinin system by plasma kallikrein, thereby reducing factor XIIa and additional plasma kallikrein generation.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Predicted pharmacokinetic/toxicological properties (PK-AZ):
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Sept. 17, 2025 | EMA | Kalvista Pharmaceuticals (Ireland) Limited | |
| July 3, 2025 | FDA | KalVista Pharmaceuticals | |
| Dec. 22, 2025 | PMDA | KalVista Pharmaceuticals Ltd. |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Hereditary angioedema | 115.55 | 90.92 | 15 | 17 | 9350 | 90619065 |
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Hereditary angioedema | 117.18 | 101.30 | 14 | 12 | 7100 | 110582173 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | B06AC08 | BLOOD AND BLOOD FORMING ORGANS OTHER HEMATOLOGICAL AGENTS OTHER HEMATOLOGICAL AGENTS Drugs used in hereditary angioedema |
| MeSH PA | D004791 | Enzyme Inhibitors |
| FDA MoA | N0000184151 | Kallikrein Inhibitors |
| FDA EPC | N0000192750 | Plasma Kallikrein Inhibitor |
Related Drugs by ATC class:
B06AC Drugs used in hereditary angioedema 7 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Hereditary angioneurotic edema | indication | 82966003 | DOID:14735 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
None
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 300MG | EKTERLY | KALVISTA | N219301 | July 3, 2025 | RX | TABLET | ORAL | 10611758 | Nov. 26, 2035 | TREATMENT OF ACUTE ATTACKS OF HEREDITARY ANGIOEDEMA (HAE) IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER |
| 300MG | EKTERLY | KALVISTA | N219301 | July 3, 2025 | RX | TABLET | ORAL | 11084809 | Nov. 26, 2035 | TREATMENT OF ACUTE ATTACKS OF HEREDITARY ANGIOEDEMA (HAE) IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER |
| 300MG | EKTERLY | KALVISTA | N219301 | July 3, 2025 | RX | TABLET | ORAL | 11198691 | Nov. 26, 2035 | TREATMENT OF ACUTE ATTACKS OF HEREDITARY ANGIOEDEMA (HAE) IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER |
| 300MG | EKTERLY | KALVISTA | N219301 | July 3, 2025 | RX | TABLET | ORAL | 11739068 | June 23, 2037 | TREATMENT OF ACUTE ATTACKS OF HEREDITARY ANGIOEDEMA (HAE) IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER |
| 300MG | EKTERLY | KALVISTA | N219301 | July 3, 2025 | RX | TABLET | ORAL | 11234939 | Jan. 26, 2039 | TREATMENT OF ACUTE ATTACKS OF HEREDITARY ANGIOEDEMA (HAE) IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 300MG | EKTERLY | KALVISTA | N219301 | July 3, 2025 | RX | TABLET | ORAL | July 3, 2030 | NEW CHEMICAL ENTITY |
| 300MG | EKTERLY | KALVISTA | N219301 | July 3, 2025 | RX | TABLET | ORAL | July 3, 2032 | TREATMENT OF ACUTE ATTACKS OF HEREDITARY ANGIOEDEMA (HAE) IN ADULT AND PEDIATRIC PATIENTS AGED12 YEARS AND OLDER |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Plasma kallikrein | Enzyme | INHIBITOR | Ki | 5.52 | DRUG LABEL | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| 1933514-13-6 | SECONDARY_CAS_RN |
| CHEMBL5095248 | ChEMBL_ID |
| C000726128 | MESH_SUPPLEMENTAL_RECORD_UI |
| 11947 | IUPHAR_LIGAND_ID |
| 4044099 | VANDF |
| C5669659 | UMLSCUI |
| CHEBI:758825 | CHEBI |
| A1J3F | PDB_CHEM_ID |
| 11529 | INN_ID |
| D12396 | KEGG_DRUG |
| 121365142 | PUBCHEM_CID |
| 396162 | MMSL |
| 44232 | MMSL |
| d10291 | MMSL |
| 020154 | NDDF |
| O5ZD2TU2B7 | UNII |
| 2717944 | RXNORM |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| EKTERLY | HUMAN PRESCRIPTION DRUG LABEL | 1 | 82928-300 | TABLET | 300 mg | ORAL | NDA | 25 sections |