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taletrectinib 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| tyrosine kinase inhibitors | 5775 | 1505514-27-1 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Taletrectinib is a kinase inhibitor that targets ROS1 and inhibits ROS1 tyrosine kinase activity. Taletrectinib inhibited ROS1-mediated signaling pathways and proliferation of ROS1 fusion-positive tumor cells.
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 |
|---|---|---|---|
| June 11, 2025 | FDA | Nuvation Bio | |
| Sept. 19, 2025 | PMDA | Nippon Kayaku Co., Ltd. |
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 |
| FDA EPC | N0000175605 | Kinase Inhibitor |
| FDA MoA | N0000194093 | Proto-Oncogene Tyrosine-Protein Kinase ROS1 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 |
|---|---|---|---|
| Reactive oxygen species 1 positive non-small cell lung cancer | indication | 72242500 |
🐶 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 200MG BASE | IBTROZI | NUVATION | N219713 | June 11, 2025 | RX | CAPSULE | ORAL | 9187489 | June 3, 2033 | TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ROS1-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) |
| EQ 200MG BASE | IBTROZI | NUVATION | N219713 | June 11, 2025 | RX | CAPSULE | ORAL | 9751887 | June 3, 2033 | TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ROS1-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| EQ 200MG BASE | IBTROZI | NUVATION | N219713 | June 11, 2025 | RX | CAPSULE | ORAL | June 11, 2030 | NEW CHEMICAL ENTITY |
| EQ 200MG BASE | IBTROZI | NUVATION | N219713 | June 11, 2025 | RX | CAPSULE | ORAL | June 11, 2032 | TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ROS1-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| High affinity nerve growth factor receptor | Kinase | INHIBITOR | IC50 | 9.21 | DRUG LABEL | DRUG LABEL | |||
| BDNF/NT-3 growth factors receptor | Kinase | INHIBITOR | IC50 | 8.64 | DRUG LABEL | DRUG LABEL | |||
| NT-3 growth factor receptor | Kinase | INHIBITOR | IC50 | 9.01 | DRUG LABEL | DRUG LABEL | |||
| Proto-oncogene tyrosine-protein kinase ROS | Kinase | INHIBITOR | IC50 | 9.68 | DRUG LABEL | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| CHEMBL4650989 | ChEMBL_ID |
| C000720459 | MESH_SUPPLEMENTAL_RECORD_UI |
| 11198 | IUPHAR_LIGAND_ID |
| 4044047 | VANDF |
| C5418160 | UMLSCUI |
| CHEBI:758413 | CHEBI |
| CHEMBL4650361 | ChEMBL_ID |
| 11404 | INN_ID |
| D12363 | KEGG_DRUG |
| 1505515-69-4 | SECONDARY_CAS_RN |
| 72202474 | PUBCHEM_CID |
| 395434 | MMSL |
| 44164 | MMSL |
| d10288 | MMSL |
| 020141 | NDDF |
| 020142 | NDDF |
| W4141180YD | UNII |
| 2716919 | RXNORM |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| IBTROZI | HUMAN PRESCRIPTION DRUG LABEL | 1 | 84651-200 | CAPSULE | 272 mg | ORAL | NDA | 28 sections |