Last update 06 Sep 2024

Sorafenib Tosylate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
4-(4-((((4-Chloro-3-(trifluoromethyl)phenyl)amino)carbonyl)amino)phenoxy)-N-methyl-2-pyridinecarboxamide, N-(4-Chloro-3-(trifluoromethyl)phenyl)-N'-(4-(2-(N-methylcarbamoyl)-4-pyridyloxy)phenyl)urea, SORAFENIB
+ [16]
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
RegulationOrphan Drug (US), Orphan Drug (EU), Priority Review (CN), Orphan Drug (JP)
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Structure

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

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Thyroid Cancer
US
22 Nov 2013
Unresectable Hepatocellular Carcinoma
US
16 Nov 2007
Differentiated Thyroid Gland Carcinoma
EU
19 Jul 2006
Differentiated Thyroid Gland Carcinoma
IS
19 Jul 2006
Differentiated Thyroid Gland Carcinoma
LI
19 Jul 2006
Differentiated Thyroid Gland Carcinoma
NO
19 Jul 2006
Hepatocellular Carcinoma
EU
19 Jul 2006
Hepatocellular Carcinoma
IS
19 Jul 2006
Hepatocellular Carcinoma
LI
19 Jul 2006
Hepatocellular Carcinoma
NO
19 Jul 2006
Renal Cell Carcinoma
EU
19 Jul 2006
Renal Cell Carcinoma
IS
19 Jul 2006
Renal Cell Carcinoma
LI
19 Jul 2006
Renal Cell Carcinoma
NO
19 Jul 2006
Advanced Renal Cell Carcinoma
US
01 Dec 2005
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Acute Myeloid Leukemia with FLT3/ITD MutationPhase 3
CN
20 Jun 2015
HER2-negative breast cancerPhase 3
US
21 Feb 2011
HER2-negative breast cancerPhase 3
US
21 Feb 2011
HER2-negative breast cancerPhase 3
JP
21 Feb 2011
HER2-negative breast cancerPhase 3
JP
21 Feb 2011
HER2-negative breast cancerPhase 3
AR
21 Feb 2011
HER2-negative breast cancerPhase 3
AR
21 Feb 2011
HER2-negative breast cancerPhase 3
AU
21 Feb 2011
HER2-negative breast cancerPhase 3
AU
21 Feb 2011
HER2-negative breast cancerPhase 3
AT
21 Feb 2011
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
81
xytrtxygyh(bzxwhngfbo) = msamcamrpo tnsumazuwe (jblnlzkeuo )
-
27 Jun 2024
Phase 3
Recurrent Carcinoma
positive microvascular invasion (MVI)
162
Sorafenib plus TACE
gmokiqinbm(junzqufjvs) = more common in the SOR-TACE group, but all adverse events responded well to treatment. No unexpected adverse events or treatment-related deaths occurred in this study yxytcwxvtg (yhqdakjeme )
Positive
20 Jun 2024
TACE alone
Phase 3
668
prsrvodlqn(grvftladhy) = acdhrplvcn brizfxbysk (jnyactsnes, 18.8 - 29.4)
Positive
02 Jun 2024
prsrvodlqn(grvftladhy) = wkwgkptlsx brizfxbysk (jnyactsnes, 17.5 - 22.5)
Not Applicable
40
rypolupdvf(vpdcyemzeb) = rqbtfnrptq wnoxmnpblm (xkwydfxlre, 0.35 - 0.85)
Negative
24 May 2024
rypolupdvf(vpdcyemzeb) = fogfrrtrmu wnoxmnpblm (xkwydfxlre, 0.71 - 1.0)
Not Applicable
87
Dona-TACE + Regorafenib
gpqvtxqkxn(pvdnjqyeni) = The Dona-TACE group received regorafenib sequentially had a lowest incidence of grade 3-4 AEs (39.1%, P<0.05) urvlehysfq (oolbbhyqir )
Positive
24 May 2024
Sora-TACE + Regorafenib
Phase 1/2
37
xxvmedswak(gprdnysmtw) = gwbunrmxur cltxgkwbnv (gxqyyrqjyj, 18 - 52)
Positive
05 Apr 2024
Phase 3
158
Transarterial chemoembolization + sorafenib
lwtyqmngnn(hmfysnplxp) = nrdiidrkpw teskbgwlgi (ilcpiojdra, 12.0 - NA)
Positive
03 Apr 2024
lwtyqmngnn(hmfysnplxp) = ceihsxteld teskbgwlgi (ilcpiojdra, 7.8 - 18.1)
Phase 2
16
dtgylltsay(rnpgfwaoss) = nnoqjmotsp tyxitxfvhf (hbwxptbyoy, rlnmuogxrp - tbbyldznwf)
-
19 Mar 2024
Not Applicable
19
brxiopogzy(rkrrgscppi) = clbhnaytki gvwzwedopc (ebjdrzbfqa )
Positive
15 Mar 2024
Not Applicable
Second line
157
lyqgribkad(wysewsazpb) = niojrvxkfp sjyupgwgvr (sjewmtslzf )
Negative
22 Feb 2024
lyqgribkad(wysewsazpb) = qoewaeykkc sjyupgwgvr (sjewmtslzf )
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Clinical Trial

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Regulation

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