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sevabertinib 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| tyrosine kinase inhibitors | 5790 | 2521285-05-0 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Sevabertinib is a reversible kinase inhibitor of human epidermal growth factor receptor 2 (HER2). It also exhibits activity against epidermal growth factor receptor (EGFR).
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 |
|---|---|---|---|
| Nov. 1, 2025 | FDA | Bayer HealthCare Pharmaceuticals 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 | L01EH06 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS PROTEIN KINASE INHIBITORS Human epidermal growth factor receptor 2 (HER2) tyrosine kinase inhibitors |
| MeSH PA | D000092004 | Tyrosine Kinase Inhibitors |
| MeSH PA | D000970 | Antineoplastic Agents |
| MeSH PA | D004791 | Enzyme Inhibitors |
| MeSH PA | D047428 | Protein Kinase Inhibitors |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
Related Drugs by ATC class:
L01EH Human epidermal growth factor receptor 2 (HER2) tyrosine kinase inhibitors 4 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Non-squamous non-small cell lung cancer (NSCLC) | indication | 254637007 | DOID:3908 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
None
Orange Book patent data (new drug applications)
None
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 10MG | HYRNUO | BAYER HEALTHCARE | N219972 | Nov. 19, 2025 | RX | TABLET | ORAL | Nov. 19, 2030 | NEW CHEMICAL ENTITY |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Epidermal growth factor receptor | Kinase | INHIBITOR | IC50 | 9.82 | DRUG LABEL | DRUG LABEL | |||
| Receptor tyrosine-protein kinase erbB-2 | Kinase | INHIBITOR | IC50 | 8.53 | DRUG LABEL | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| CHEMBL6068074 | ChEMBL_ID |
| C000731961 | MESH_SUPPLEMENTAL_RECORD_UI |
| 4044438 | VANDF |
| C5983435 | UMLSCUI |
| CHEBI:759992 | CHEBI |
| A1JBI | PDB_CHEM_ID |
| 13219 | INN_ID |
| D13098 | KEGG_DRUG |
| 155234713 | PUBCHEM_CID |
| 399535 | MMSL |
| 44535 | MMSL |
| d10341 | MMSL |
| 020293 | NDDF |
| 13491 | IUPHAR_LIGAND_ID |
| 2A7VPM5RWH | UNII |
| 2728187 | RXNORM |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| HYRNUO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50419-397 | TABLET, FILM COATED | 10 mg | ORAL | NDA | 28 sections |