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sunvozertinib 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| tyrosine kinase inhibitors | 5778 | 2370013-12-8 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Sunvozertinib is a kinase inhibitor of epidermal growth factor receptor (EGFR). Sunvozertinib inhibits EGFR signaling by binding to mutant EGFR, including exon 20 insertion mutations, resulting in inhibition of tumor cell proliferation.
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 |
|---|---|---|---|
| July 2, 2025 | FDA | Dizal Pharmaceutical |
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 |
|---|---|---|
| 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 |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations | indication | 703228009 |
🐶 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 150MG | ZEGFROVY | DIZAL JIANGSU | N219839 | July 2, 2025 | RX | TABLET | ORAL | 11504375 | Jan. 28, 2039 | TREATMENT OF PATIENTS WITH NON-SMALL CELL LUNG CANCER (NSCLC) WITH EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 20 EXON INSERTION MUTATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER PLATINUM-BASED CHEMOTHERAPY |
| 150MG | ZEGFROVY | DIZAL JIANGSU | N219839 | July 2, 2025 | RX | TABLET | ORAL | 11896597 | Jan. 28, 2039 | TREATMENT OF PATIENTS WITH NON-SMALL CELL LUNG CANCER (NSCLC) WITH EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 20 EXON INSERTION MUTATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER PLATINUM-BASED CHEMOTHERAPY |
| 200MG | ZEGFROVY | DIZAL JIANGSU | N219839 | July 2, 2025 | RX | TABLET | ORAL | 11504375 | Jan. 28, 2039 | TREATMENT OF PATIENTS WITH NON-SMALL CELL LUNG CANCER (NSCLC) WITH EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 20 EXON INSERTION MUTATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER PLATINUM-BASED CHEMOTHERAPY |
| 200MG | ZEGFROVY | DIZAL JIANGSU | N219839 | July 2, 2025 | RX | TABLET | ORAL | 11896597 | Jan. 28, 2039 | TREATMENT OF PATIENTS WITH NON-SMALL CELL LUNG CANCER (NSCLC) WITH EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 20 EXON INSERTION MUTATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER PLATINUM-BASED CHEMOTHERAPY |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 150MG | ZEGFROVY | DIZAL JIANGSU | N219839 | July 2, 2025 | RX | TABLET | ORAL | July 2, 2030 | NEW CHEMICAL ENTITY |
| 200MG | ZEGFROVY | DIZAL JIANGSU | N219839 | July 2, 2025 | RX | TABLET | ORAL | July 2, 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 | 8.62 | DRUG LABEL | DRUG LABEL | |||
| Tyrosine-protein kinase BTK | Kinase | INHIBITOR | IC50 | 8.54 | IUPHAR |
External reference:
| ID | Source |
|---|---|
| CHEMBL5314564 | ChEMBL_ID |
| C000731668 | MESH_SUPPLEMENTAL_RECORD_UI |
| 11672 | IUPHAR_LIGAND_ID |
| C5667199 | UMLSCUI |
| CHEBI:759262 | CHEBI |
| 11819 | INN_ID |
| D12506 | KEGG_DRUG |
| 139377809 | PUBCHEM_CID |
| 44231 | MMSL |
| d10290 | MMSL |
| 020157 | NDDF |
| L1Q2K5JYO8 | UNII |
| 2719226 | RXNORM |
Pharmaceutical products:
None