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Drug ReportsSorafenib
Nexavar(sorafenib)
Nexavar, Sorafenib (sorafenib) is a small molecule pharmaceutical. Sorafenib was first approved as Nexavar on 2005-12-20. It is used to treat hepatocellular carcinoma, renal cell carcinoma, and thyroid neoplasms in the USA. It has been approved in Europe to treat hepatocellular carcinoma and renal cell carcinoma. The pharmaceutical is active against vascular endothelial growth factor receptor 2, mast/stem cell growth factor receptor Kit, and receptor-type tyrosine-protein kinase FLT3. In addition, it is known to target proto-oncogene tyrosine-protein kinase receptor Ret, platelet-derived growth factor receptor beta, vascular endothelial growth factor receptor 3, serine/threonine-protein kinase B-raf, RAF proto-oncogene serine/threonine-protein kinase, fibroblast growth factor receptor 1, cyclin-dependent kinase 8, cyclin-dependent kinase 19, and discoidin domain-containing receptor 2.
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Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
digestive system diseasesD004066
urogenital diseasesD000091642
endocrine system diseasesD004700
Trade Name
FDA
EMA
Nexavar (generic drugs available since 2020-09-10)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Sorafenib tosylate
Tradename
Company
Number
Date
Products
NEXAVARBayerN-021923 RX2005-12-20
1 products, RLD, RS
Labels
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Sorafenib Tosylate, Nexavar, Bayer Hlthcare
97374882028-09-10DPU-1480, U-1696, U-2107
88779332027-12-24DS, DPU-1624
86181412023-02-11U-1480
ATC Codes
L: Antineoplastic and immunomodulating agents
L01: Antineoplastic agents
L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
L01EX: Other protein kinase inhibitors in atc
L01EX02: Sorafenib
HCPCS
No data
Clinical
Clinical Trials
853 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Liver neoplasmsD008113EFO_1001513C22.073141541250290
Hepatocellular carcinomaD006528C22.056104461038222
Renal cell carcinomaD002292EFO_000037612411612992
Neoplasm metastasisD009362EFO_000970831115
ThrombosisD0139271123
HepatectomyD00649811
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C8054175778
Myeloid leukemia acuteD015470C92.021174841
Breast neoplasmsD001943EFO_0003869C509211228
MelanomaD0085457152224
Non-small-cell lung carcinomaD0022898124123
Kidney neoplasmsD007680EFO_0003865C64763621
Pancreatic neoplasmsD010190EFO_0003860C2588116
Thyroid neoplasmsD013964EFO_0003841111315
LeukemiaD007938C95751110
AdenocarcinomaD000230617
Show 17 more
Indications Phases 2
Indications Phases 1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Drug-related side effects and adverse reactionsD064420T88.711
HypertensionD006973EFO_0000537I1011
ProteinuriaD011507HP_0000093R8011
Gastrointestinal neoplasmsD005770C26.911
Progression-free survivalD00007798211
Radiofrequency ablationD00007870311
ApoptosisD01720911
Covid-19D000086382U07.111
InfectionsD007239EFO_000054411
SarcopeniaD055948EFO_1000653M62.8411
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameSorafenib
INNsorafenib
Description
Sorafenib is a member of the class of phenylureas that is urea in which one of the nitrogens is substituted by a 4-chloro-3-trifluorophenyl group while the other is substituted by a phenyl group which, in turn, is substituted at the para position by a [2-(methylcarbamoyl)pyridin-4-yl]oxy group. It has a role as an antineoplastic agent, an EC 2.7.11.1 (non-specific serine/threonine protein kinase) inhibitor, a tyrosine kinase inhibitor, an angiogenesis inhibitor, an anticoronaviral agent and a ferroptosis inducer. It is a pyridinecarboxamide, a member of monochlorobenzenes, an aromatic ether, a member of (trifluoromethyl)benzenes and a member of phenylureas.
Classification
Small molecule
Drug classrapidly accelerated fibrosarcoma (RAF) kinase inhibitors
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Structure (InChI/SMILES or Protein Sequence)
CNC(=O)c1cc(Oc2ccc(NC(=O)Nc3ccc(Cl)c(C(F)(F)F)c3)cc2)ccn1
Identifiers
PDB
CAS-ID284461-73-0
RxCUI
ChEMBL IDCHEMBL1336
ChEBI ID50924
PubChem CID216239
DrugBankDB00398
UNII ID9ZOQ3TZI87 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
CDK19
CDK19
BRAF
BRAF
FGFR1
FGFR1
Organism
Homo sapiens
Gene name
CDK19
Gene synonyms
CDC2L6, CDK11, KIAA1028
NCBI Gene ID
Protein name
cyclin-dependent kinase 19
Protein synonyms
CDC2-related protein kinase 6, CDK8-like cyclin-dependent kinase, cell division cycle 2-like 6 (CDK8-like), Cell division cycle 2-like protein kinase 6, Cell division protein kinase 19, cyclin-dependent kinase (CDC2-like) 11, Cyclin-dependent kinase 11, Death-preventing kinase
Uniprot ID
Mouse ortholog
Cdk19 (78334)
cyclin-dependent kinase 19 (Q8BWD8)
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 55,282 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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28,793 adverse events reported
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