Nexavar(sorafenib)

Nexavar (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, receptor-type tyrosine-protein kinase FLT3, and mast/stem cell growth factor receptor Kit. In addition, it is known to target cyclin-dependent kinase 19, discoidin domain-containing receptor 2, proto-oncogene tyrosine-protein kinase receptor Ret, RAF proto-oncogene serine/threonine-protein kinase, cyclin-dependent kinase 8, serine/threonine-protein kinase B-raf, fibroblast growth factor receptor 1, platelet-derived growth factor receptor beta, and vascular endothelial growth factor receptor 3.

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Therapeutic Areas

Therapeutic Area	MeSH
neoplasms	D009369
digestive system diseases	D004066
urogenital diseases	D000091642
endocrine system diseases	D004700

Trade Name

FDA

EMA

Nexavar (generic drugs available since 2020-09-10)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Sorafenib tosylate

Tradename	Company	Number	Date	Products
NEXAVAR	Bayer	N-021923 RX	2005-12-20	1 products, RLD, RS

Labels

FDA

EMA

Brand Name	Status	Last Update
nexavar	New Drug Application	2020-07-09
sorafenib	ANDA	2023-05-18

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
hepatocellular carcinoma	—	D006528	C22.0
renal cell carcinoma	EFO_0000376	D002292	—
thyroid neoplasms	EFO_0003841	D013964	—

Agency Specific

FDA

EMA

No data

Patent Expiration

Patent	Expires	Flag	FDA Information
Sorafenib Tosylate, Nexavar, Bayer Hlthcare
9737488	2028-09-10	DP	U-1480, U-1696, U-2107
8877933	2027-12-24	DS, DP	U-1624
8618141	2023-02-11		U-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

700 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 neoplasms	D008113	EFO_1001513	C22.0	68	108	45	10	30	224
Renal cell carcinoma	D002292			10	37	15	1	17	75
Neoplasm metastasis	D009362	EFO_0009708		—	2	—	1	1	4
Thrombosis	D013927			1	1	—	2	—	3
Hepatectomy	D006498			—	—	—	1	—	1

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Neoplasms	D009369		C80	51	16	4	—	5	72
Hepatocellular carcinoma	D006528		C22.0	11	16	18	—	4	44
Myeloid leukemia acute	D015470		C92.0	19	14	2	—	5	33
Breast neoplasms	D001943	EFO_0003869	C50	9	20	1	—	1	26
Non-small-cell lung carcinoma	D002289			8	12	4	—	1	23
Melanoma	D008545			7	15	2	—	—	22
Pancreatic neoplasms	D010190	EFO_0003860	C25	8	8	1	—	—	16
Kidney neoplasms	D007680	EFO_0003865	C64	7	5	3	—	2	16
Thyroid neoplasms	D013964	EFO_0003841		—	11	1	—	2	14
Leukemia	D007938		C95	5	3	1	—	—	7

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Prostatic neoplasms	D011471		C61	6	10	—	—	—	14
Lung neoplasms	D008175		C34.90	6	9	—	—	—	14
Sarcoma	D012509			5	10	—	—	—	13
Glioblastoma	D005909	EFO_0000515		7	8	—	—	—	12
Colorectal neoplasms	D015179			5	8	—	—	1	12
Precursor cell lymphoblastic leukemia-lymphoma	D054198		C91.0	7	3	—	—	—	9
Myelodysplastic syndromes	D009190		D46	5	4	—	—	—	8
Brain neoplasms	D001932	EFO_0003833	C71	6	3	—	—	1	8
Ovarian neoplasms	D010051	EFO_0003893	C56	1	8	—	—	—	8
Urinary bladder neoplasms	D001749		C67	2	6	—	—	—	8

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Megakaryoblastic leukemia acute	D007947		C94.2	3	—	—	—	—	3
Myelomonocytic leukemia acute	D015479		C92.5	3	—	—	—	—	3
Basophilic leukemia acute	D015471		C94.8	3	—	—	—	—	3
Erythroblastic leukemia acute	D004915	EFO_1001257	C94.0	3	—	—	—	—	3
Eosinophilic leukemia acute	D015472			3	—	—	—	—	3
Non-hodgkin lymphoma	D008228		C85.9	2	—	—	—	—	2
Astrocytoma	D001254	EFO_0000271		2	—	—	—	—	2
Oligodendroglioma	D009837	EFO_0000631		2	—	—	—	—	2
Myeloid leukemia	D007951		C92	2	—	—	—	—	2
Hematologic neoplasms	D019337			1	—	—	—	—	1

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Indications Without Phase

Indication	MeSH	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Gastrointestinal neoplasms	D005770	C26.9	—	—	—	—	1	1
Radiofrequency ablation	D000078703		—	—	—	—	1	1
Covid-19	D000086382	U07.1	—	—	—	—	1	1

Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	SORAFENIB
INN	sorafenib
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 class	rapidly accelerated fibrosarcoma (RAF) kinase inhibitors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	CNC(=O)c1cc(Oc2ccc(NC(=O)Nc3ccc(Cl)c(C(F)(F)F)c3)cc2)ccn1

Identifiers

PDB	1UWH
CAS-ID	284461-73-0
RxCUI	495881
ChEMBL ID	CHEMBL1336
ChEBI ID	50924
PubChem CID	216239
DrugBank	DB00398
UNII ID	9ZOQ3TZI87 (ChemIDplus, GSRS)

Target

Agency Approved

KDR

FLT3

KIT

Organism

Homo sapiens

Gene name

KDR

Gene synonyms

FLK1, VEGFR2

NCBI Gene ID

3791

Protein name

vascular endothelial growth factor receptor 2

Protein synonyms

CD309, Fetal liver kinase 1, fetal liver kinase-1, FLK-1, KDR, Kinase insert domain receptor, kinase insert domain receptor (a type III receptor tyrosine kinase), Protein-tyrosine kinase receptor flk-1, soluble VEGFR2, tyrosine kinase growth factor receptor

Uniprot ID

Q14178

Mouse ortholog

Kdr (16542)

vascular endothelial growth factor receptor 2 (Q8VCD0)

Alternate

CDK19

DDR2

RET

RAF1

CDK8

BRAF

FGFR1

PDGFRB

FLT4

Organism

Homo sapiens

Gene name

CDK19

Gene synonyms

CDC2L6, CDK11, KIAA1028

NCBI Gene ID

23097

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

Q9BWU1

Mouse ortholog

Cdk19 (78334)

cyclin-dependent kinase 19 (Q8BWD8)

Variants

Clinical Variant

Identifier	Target mutation	Effect	Evaluation	Status
VCV000336258	EPAS1, 1035-7C>G	drug response	2022-12-02	2B

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Trends

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Safety

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Adverse Events

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409 adverse events reported

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