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ensartinib 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| tyrosine kinase inhibitors | 5845 | 1370651-20-9 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Ensartinib is a kinase inhibitor of anaplastic lymphoma kinase (ALK) and inhibits other kinases including MET and ROS1. In vitro, ensartinib inhibited phosphorylation of ALK and its downstream signaling proteins AKT, ERK, and S6, thereby blocking ALK-mediated signaling pathways and inhibiting proliferation in cell lines harboring ALK fusions and mutations. In vivo, ensartinib showed anti-tumor activity in a mouse xenograft model of human NSCLC harboring an ALK fusion.
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 |
|---|---|---|---|
| Dec. 18, 2024 | FDA | : Xcovery Holdings, 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| Anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer | indication | 830151004 |
🐶 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 100MG BASE | ENSACOVE | XCOVERY | N218171 | Dec. 18, 2024 | RX | CAPSULE | ORAL | 9296724 | June 18, 2029 | TREATMENT OF ADULT PATIENTS WITH ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHO HAVE NOT PREVIOUSLY RECEIVED AN ALK-INHIBITOR |
| EQ 25MG BASE | ENSACOVE | XCOVERY | N218171 | Dec. 18, 2024 | RX | CAPSULE | ORAL | 9296724 | June 18, 2029 | TREATMENT OF ADULT PATIENTS WITH ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHO HAVE NOT PREVIOUSLY RECEIVED AN ALK-INHIBITOR |
| EQ 100MG BASE | ENSACOVE | XCOVERY | N218171 | Dec. 18, 2024 | RX | CAPSULE | ORAL | 10899744 | June 1, 2037 | TREATMENT OF ADULT PATIENTS WITH ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHO HAVE NOT PREVIOUSLY RECEIVED AN ALK-INHIBITOR |
| EQ 25MG BASE | ENSACOVE | XCOVERY | N218171 | Dec. 18, 2024 | RX | CAPSULE | ORAL | 10899744 | June 1, 2037 | TREATMENT OF ADULT PATIENTS WITH ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHO HAVE NOT PREVIOUSLY RECEIVED AN ALK-INHIBITOR |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| EQ 100MG BASE | ENSACOVE | XCOVERY | N218171 | Dec. 18, 2024 | RX | CAPSULE | ORAL | Dec. 18, 2029 | NEW CHEMICAL ENTITY |
| EQ 25MG BASE | ENSACOVE | XCOVERY | N218171 | Dec. 18, 2024 | RX | CAPSULE | ORAL | Dec. 18, 2029 | NEW CHEMICAL ENTITY |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Hepatocyte growth factor receptor | Kinase | INHIBITOR | IC50 | 9.13 | DRUG LABEL | DRUG LABEL | |||
| ALK tyrosine kinase receptor | Kinase | INHIBITOR | IC50 | 9.60 | DRUG LABEL | DRUG LABEL | |||
| Proto-oncogene tyrosine-protein kinase ROS | Kinase | INHIBITOR | IC50 | 8 | DRUG LABEL | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| CHEMBL4113131 | ChEMBL_ID |
| C000629294 | MESH_SUPPLEMENTAL_RECORD_UI |
| DB14860 | DRUGBANK_ID |
| DB13104 | DRUGBANK_ID |
| 4044016 | VANDF |
| C4524311 | UMLSCUI |
| CHEBI:756608 | CHEBI |
| CHEMBL4297219 | ChEMBL_ID |
| 10339 | INN_ID |
| 2137030-98-7 | SECONDARY_CAS_RN |
| 56960363 | PUBCHEM_CID |
| 8959 | IUPHAR_LIGAND_ID |
| SMA5ZS5B22 | UNII |
| 2712546 | RXNORM |
| D11346 | KEGG_DRUG |
| 391509 | MMSL |
| 43616 | MMSL |
| d10243 | MMSL |
| 019951 | NDDF |
| 019952 | NDDF |
| SMA5ZS5B22 | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| ENSACOVE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 83076-1025 | CAPSULE | 25 mg | ORAL | NDA | 27 sections |
| ENSACOVE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 83076-1100 | CAPSULE | 100 mg | ORAL | NDA | 27 sections |