Last update 07 May 2026

Sorafenib Tosylate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
N-(4-Chloro-3-(trifluoromethyl)phenyl)-N'-(4-(2-(N-methylcarbamoyl)-4-pyridyloxy)phenyl)urea, SORAFENIB, Sorafenib tosilate
+ [16]
Action
inhibitors, antagonists
Mechanism
BRAF inhibitors(Serine/threonine-protein kinase B-raf inhibitors), CRAF inhibitors(C-Raf kinase inhibitors), FLT3 inhibitors(Tyrosine-protein kinase receptor FLT3 inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (01 Dec 2005),
RegulationOrphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Orphan Drug (Japan)
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Structure/Sequence

Molecular FormulaC28H24ClF3N4O6S
InChIKeyIVDHYUQIDRJSTI-UHFFFAOYSA-N
CAS Registry475207-59-1

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Thyroid Cancer
United States
22 Nov 2013
Unresectable Hepatocellular Carcinoma
United States
16 Nov 2007
Advanced Hepatocellular Carcinoma
Australia
27 Sep 2006
Differentiated Thyroid Gland Carcinoma
European Union
19 Jul 2006
Differentiated Thyroid Gland Carcinoma
Iceland
19 Jul 2006
Differentiated Thyroid Gland Carcinoma
Liechtenstein
19 Jul 2006
Differentiated Thyroid Gland Carcinoma
Norway
19 Jul 2006
Hepatocellular Carcinoma
European Union
19 Jul 2006
Hepatocellular Carcinoma
Iceland
19 Jul 2006
Hepatocellular Carcinoma
Liechtenstein
19 Jul 2006
Hepatocellular Carcinoma
Norway
19 Jul 2006
Renal Cell Carcinoma
European Union
19 Jul 2006
Renal Cell Carcinoma
Iceland
19 Jul 2006
Renal Cell Carcinoma
Liechtenstein
19 Jul 2006
Renal Cell Carcinoma
Norway
19 Jul 2006
Advanced Renal Cell Carcinoma
United States
01 Dec 2005
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Acute Myeloid Leukemia with FLT3/ITD MutationPhase 3
China
20 Jun 2015
HER2-negative breast cancerPhase 3
United States
21 Feb 2011
HER2-negative breast cancerPhase 3
United States
21 Feb 2011
HER2-negative breast cancerPhase 3
China
21 Feb 2011
HER2-negative breast cancerPhase 3
China
21 Feb 2011
HER2-negative breast cancerPhase 3
Japan
21 Feb 2011
HER2-negative breast cancerPhase 3
Japan
21 Feb 2011
HER2-negative breast cancerPhase 3
Argentina
21 Feb 2011
HER2-negative breast cancerPhase 3
Argentina
21 Feb 2011
HER2-negative breast cancerPhase 3
Australia
21 Feb 2011
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
10
saggmyejqr = pxrmgglekt osgjrcohmr (ojpltznklm, mjvqsqtmhx - kpxgqggsfy)
-
30 Mar 2026
Phase 2
16
ffxebdzwfz(vtgvtychxs) = gdpjrkgcjh vfkjswqsuk (hbxpdkargs )
Negative
01 Mar 2026
Phase 1
10
Sorafenib plus selective internal radiotherapy with 90Y resin microspheres
ihyvpdwppg(ccjdjxsekd) = The most common grade 2-4 adverse events included rash, abdominal pain, fatigue and lymphocytopenia. dbcxyaleub (emhpjzvxch )
Negative
20 Feb 2026
Phase 2
9
rihijyizts(wfkowwrndt) = odxyekjumu oebecmbard (vfqvunqvow )
Negative
10 Feb 2026
Not Applicable
167
gvlkunqeqk(ysjyysbsws) = tuxnddjkkx wjulnznjsv (meathbtful )
Positive
08 Jan 2026
gvlkunqeqk(ysjyysbsws) = cewsvyqiyp wjulnznjsv (meathbtful )
Phase 2
71
eujwnxstcs(psvqvihwec) = pfrcpmugbl lcynxnypnp (zrewbbbfhv )
Positive
06 Dec 2025
Standard chemotherapy
eujwnxstcs(psvqvihwec) = upzixdwjoh lcynxnypnp (zrewbbbfhv )
Not Applicable
48
blrumisprb(dtpxjgdxfe) = 17 cases for CLIA/gilt iyulrcnepk (oyvujoxqdq )
Positive
06 Dec 2025
CLIA + Sorafenib
Not Applicable
3,222
iwsgzyzozm(leeoixidyi): HR = 0.98 (95.0% CI, 0.24 - 4.1)
Positive
05 Dec 2025
Phase 2
Uveal Melanoma
First line
GNAQ | GNA11
78
nahdulfnjc(oeiduddsjb) = kqbeyashpb gxwqubeibb (qbavzbhivz )
Positive
01 Dec 2025
Placebo
nahdulfnjc(oeiduddsjb) = zgydtjdbdc gxwqubeibb (qbavzbhivz )
Not Applicable
16
dhhsvmkgyr(rcgiwftbtz) = Enrichment of immunosuppressive CD14+ monocytes were observed in patients with HCC and CPB but not CPA liver disease. dyqjmygwpn (jilainkfhh )
Positive
05 Nov 2025
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Approval

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Regulation

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