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tovorafenib 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| Raf (Rapidely Accelerated Fibrosarcoma) kinase inhibitors | 5819 | 1096708-71-2 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Tovorafenib is a Type II RAF kinase inhibitor of mutant BRAF V600E, wild-type BRAF, and wild-type CRAF kinases. Tovorafenib exhibited antitumor activity in cultured cells and xenograft tumor models harboring BRAF V600E and V600D mutations, and in a xenograft model harboring a BRAF 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 |
|---|---|---|---|
| April 23, 2024 | FDA | Day One Biopharmaceuticals, Inc. | |
| April 20, 2026 | EMA | Ipsen Pharma |
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 | L01EC04 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS PROTEIN KINASE INHIBITORS B-Raf serine-threonine kinase (BRAF) inhibitors |
| FDA EPC | N0000175605 | Kinase Inhibitor |
| FDA MoA | N0000190118 | Cytochrome P450 3A Inducers |
| FDA MoA | N0000194133 | Type II RAF Kinase Inhibitors |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:68495 | apoptosis inducer |
| CHEBI has role | CHEBI:75047 | B-Raf inhibitor |
Related Drugs by ATC class:
L01EC B-Raf serine-threonine kinase (BRAF) inhibitors 3 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Relapsed or refractory pediatric low-grade glioma | indication | 74532006 |
🐶 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 |
|---|---|---|---|---|---|---|---|---|---|
| 100MG | OJEMDA | DAY ONE BIOPHARMS | N217700 | April 23, 2024 | RX | TABLET | ORAL | April 23, 2029 | NEW CHEMICAL ENTITY |
| 25MG/ML | OJEMDA | DAY ONE BIOPHARMS | N218033 | April 23, 2024 | RX | FOR SUSPENSION | ORAL | April 23, 2029 | NEW CHEMICAL ENTITY |
| 100MG | OJEMDA | DAY ONE BIOPHARMS | N217700 | April 23, 2024 | RX | TABLET | ORAL | April 23, 2031 | TREATMENT OF PATIENTS 6 MONTHS OF AGE AND OLDER WITH RELAPSED OR REFRACTORY PEDIATRIC LOW-GRADE GLIOMA (LGG) HARBORING A BRAF FUSION OR REARRANGEMENT, OR BRAF V600 MUTATION |
| 25MG/ML | OJEMDA | DAY ONE BIOPHARMS | N218033 | April 23, 2024 | RX | FOR SUSPENSION | ORAL | April 23, 2031 | TREATMENT OF PATIENTS 6 MONTHS OF AGE AND OLDER WITH RELAPSED OR REFRACTORY PEDIATRIC LOW-GRADE GLIOMA (LGG) HARBORING A BRAF FUSION OR REARRANGEMENT, OR BRAF V600 MUTATION |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| RAF proto-oncogene serine/threonine-protein kinase | Kinase | INHIBITOR | IC50 | 9.15 | DRUG LABEL | DRUG LABEL | |||
| Serine/threonine-protein kinase B-raf | Kinase | INHIBITOR | IC50 | 8.08 | DRUG LABEL | DRUG LABEL | |||
| Breakpoint cluster region protein | Kinase | Kd | 6.53 | CHEMBL | |||||
| Ephrin type-A receptor 2 | Kinase | Kd | 6.09 | CHEMBL | |||||
| Myosin light chain kinase, smooth muscle | Kinase | Kd | 5.36 | CHEMBL | |||||
| LIM domain kinase 1 | Kinase | Kd | 5.99 | CHEMBL | |||||
| Abelson tyrosine-protein kinase 2 | Kinase | Kd | 7 | CHEMBL | |||||
| Mitogen-activated protein kinase 11 | Kinase | Kd | 6.17 | CHEMBL | |||||
| Mitogen-activated protein kinase 14 | Kinase | Kd | 6.45 | CHEMBL | |||||
| Tyrosine-protein kinase FRK | Kinase | Kd | 6.76 | CHEMBL | |||||
| Dual specificity protein kinase CLK1 | Kinase | Kd | 6.03 | CHEMBL | |||||
| Epithelial discoidin domain-containing receptor 1 | Kinase | Kd | 7.20 | CHEMBL | |||||
| Platelet-derived growth factor receptor beta | Kinase | Kd | 4.95 | CHEMBL | |||||
| TGF-beta receptor type-2 | Kinase | Kd | 5.79 | CHEMBL | |||||
| Wee1-like protein kinase | Kinase | Kd | 6.60 | CHEMBL | |||||
| Mitogen-activated protein kinase kinase kinase MLT | Kinase | Kd | 6.35 | CHEMBL | |||||
| Discoidin domain-containing receptor 2 | Kinase | Kd | 6.64 | CHEMBL | |||||
| Dual specificity mitogen-activated protein kinase kinase 4 | Kinase | Kd | 6.84 | CHEMBL | |||||
| Ephrin type-A receptor 1 | Kinase | Kd | 5.97 | CHEMBL | |||||
| Dual specificity tyrosine-phosphorylation-regulated kinase 1A | Kinase | Kd | 5.49 | CHEMBL | |||||
| Ephrin type-B receptor 6 | Kinase | Kd | 5.48 | CHEMBL | |||||
| Mitogen-activated protein kinase kinase kinase 1 | Kinase | Kd | 5.68 | CHEMBL | |||||
| Receptor-interacting serine/threonine-protein kinase 3 | Kinase | Kd | 5.75 | CHEMBL | |||||
| Ephrin type-B receptor 4 | Kinase | Kd | 5.03 | CHEMBL | |||||
| Tyrosine-protein kinase ABL1 | Kinase | Kd | 6.30 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| QOP | PDB_CHEM_ID |
| CHEMBL3348923 | ChEMBL_ID |
| C000626518 | MESH_SUPPLEMENTAL_RECORD_UI |
| DB15266 | DRUGBANK_ID |
| 4043091 | VANDF |
| C4287814 | UMLSCUI |
| 11985 | INN_ID |
| 25161177 | PUBCHEM_CID |
| 384705 | MMSL |
| 42790 | MMSL |
| d10185 | MMSL |
| 019731 | NDDF |
| 9977 | IUPHAR_LIGAND_ID |
| ZN90E4027M | UNII |
| 2682434 | RXNORM |
| D12291 | KEGG_DRUG |
| CHEBI:167672 | CHEBI |
| ZN90E4027M | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| OJEMDA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 82950-001 | TABLET, FILM COATED | 100 mg | ORAL | NDA | 32 sections |