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aprocitentan 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| endothelin receptor antagonists | 5812 | 1103522-45-7 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Aprocitentan is an ERA that inhibits the binding of endothelin (ET)-1 to ETA and ETB receptors. ET-1, via its receptors (ETA and ETB), mediates a variety of deleterious effects such as vasoconstriction, fibrosis, cell proliferation, and inflammation.
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 |
|---|---|---|---|
| March 19, 2024 | FDA | Idorsia Pharmaceuticals US Inc. |
FDA Adverse Event Reporting System (Female)
None
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
None
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | C02KN01 | CARDIOVASCULAR SYSTEM ANTIHYPERTENSIVES OTHER ANTIHYPERTENSIVES Other antihypertensives |
| FDA MoA | N0000175364 | Endothelin Receptor Antagonists |
| FDA EPC | N0000175581 | Endothelin Receptor Antagonist |
| CHEBI has role | CHEBI:35674 | antihypertensive agent |
| CHEBI has role | CHEBI:49103 | drug metabolite |
| CHEBI has role | CHEBI:51451 | endothelin receptor antagonist |
| CHEBI has role | CHEBI:76206 | xenobiotic metabolite |
| CHEBI has role | CHEBI:231911 | renoprotective agent |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Hypertension | indication | 38341003 | DOID:10763 |
| Pregnancy, function | contraindication | 289908002 |
🐶 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 12.5MG | TRYVIO | IDORSIA | N217686 | March 19, 2024 | RX | TABLET | ORAL | 8324232 | Sept. 21, 2029 | TREATMENT OF HYPERTENSION IN COMBINATION WITH OTHER ANTIHYPERTENSIVE DRUGS, TO LOWER BLOOD PRESSURE IN ADULT PATIENTS WHO ARE NOT ADEQUATELY CONTROLLED ON OTHER DRUGS |
| 12.5MG | TRYVIO | IDORSIA | N217686 | March 19, 2024 | RX | TABLET | ORAL | 11174247 | Nov. 6, 2037 | TREATMENT OF HYPERTENSION IN COMBINATION WITH OTHER ANTIHYPERTENSIVE DRUGS, INCLUDING AN ANGIOTENSIN RECEPTOR BLOCKER, TO LOWER BLOOD PRESSURE IN ADULT PATIENTS WHO ARE NOT ADEQUATELY CONTROLLED ON OTHER DRUGS |
| 12.5MG | TRYVIO | IDORSIA | N217686 | March 19, 2024 | RX | TABLET | ORAL | 11787782 | March 2, 2038 | TREATMENT OF HYPERTENSION IN COMBINATION WITH OTHER ANTIHYPERTENSIVE DRUGS, INCLUDING AN ANGIOTENSIN CONVERTING ENZYME INHIBITOR, TO LOWER BLOOD PRESSURE IN ADULT PATIENTS WHO ARE NOT ADEQUATELY CONTROLLED ON OTHER DRUGS |
| 12.5MG | TRYVIO | IDORSIA | N217686 | March 19, 2024 | RX | TABLET | ORAL | 11680058 | July 26, 2038 | TREATMENT OF HYPERTENSION IN COMBINATION WITH OTHER ANTIHYPERTENSIVE DRUGS, TO LOWER BLOOD PRESSURE IN ADULT PATIENTS WHO ARE NOT ADEQUATELY CONTROLLED ON OTHER DRUGS |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 12.5MG | TRYVIO | IDORSIA | N217686 | March 19, 2024 | RX | TABLET | ORAL | March 22, 2029 | NEW CHEMICAL ENTITY |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Endothelin-1 receptor | GPCR | ANTAGONIST | IC50 | 8.47 | DRUG LABEL | DRUG LABEL | |||
| Endothelin B receptor | GPCR | ANTAGONIST | IC50 | 6.01 | DRUG LABEL | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| A1JJR | PDB_CHEM_ID |
| CHEMBL2165326 | ChEMBL_ID |
| C572762 | MESH_SUPPLEMENTAL_RECORD_UI |
| DB15059 | DRUGBANK_ID |
| 4043090 | VANDF |
| C5139816 | UMLSCUI |
| 10552 | INN_ID |
| 25099191 | PUBCHEM_CID |
| 383887 | MMSL |
| 42717 | MMSL |
| d10174 | MMSL |
| 019700 | NDDF |
| 10070 | IUPHAR_LIGAND_ID |
| MZI81HV01P | UNII |
| 2679059 | RXNORM |
| D11441 | KEGG_DRUG |
| MZI81HV01P | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| TRYVIO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 80491-8012 | TABLET, FILM COATED | 12.50 mg | ORAL | NDA | 32 sections |