Last update 15 Feb 2025

Donafenib Tosylate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Donafenib, Donafenib tosilate, Zeprosen
+ [4]
Mechanism
CRAF inhibitors(C-Raf kinase inhibitors), PDGFR antagonists(Platelet-derived growth factor receptor antagonists), VEGFR antagonists(Vascular endothelial growth factor receptor antagonists)
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
CN (08 Jun 2021),
RegulationPriority Review (CN)
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Structure/Sequence

Molecular FormulaC28H24ClF3N4O6S
InChIKeyIVDHYUQIDRJSTI-NIIDSAIPSA-N
CAS Registry1333386-17-6

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Thyroid Cancer
CN
10 Aug 2022
Hepatocellular Carcinoma
CN
08 Jun 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Refractory Thyroid Gland CarcinomaPhase 3
CN
29 Aug 2018
Refractory Differentiated Thyroid Gland CarcinomaPhase 3
CN
26 Jul 2018
Colorectal CancerPhase 3
CN
23 Dec 2016
Metastatic Colorectal CarcinomaPhase 3
CN
23 Dec 2016
Advanced Hepatocellular CarcinomaPhase 3
CN
01 Mar 2016
Advanced Malignant Solid NeoplasmPhase 2
CN
10 May 2024
Advanced gastric carcinomaPhase 2
CN
11 Jan 2021
Bile Duct NeoplasmsPhase 2
CN
11 Jan 2021
Nasopharyngeal CarcinomaPhase 2
CN
08 Feb 2017
Metastatic gastric adenocarcinomaPhase 2
CN
16 May 2016
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
Hepatocellular Carcinoma
Adjuvant
microvascular invasion (MVI) | satellite nodule(s) | more than three tumor nodules ...
30
Donafenib + PD-1 inhibitor (toripalimab)
xqtlvctvrf(itkfqfdnml) = kahzblvqgc fcxutnljfg (kvtmtcawsi, 67.8% - 95.4)
Positive
23 Jan 2025
Phase 2
23
rjmctpsohp(mkkfaqomip) = eqpbqljsba znnnxpyefy (slwzmrjbha )
Positive
07 Dec 2024
Phase 2
21
donafenib + sintilimab + GEMOX-HAIC
rcgyceydsy(jqefcqztut) = tmbiqyerhy vbygancomm (qaxndnlmbe, 18.1% - 61.6)
Positive
07 Dec 2024
ASCO2024
ManualManual
Not Applicable
102
lciwamarzr(iifivttais) = fnprnwiiwt ivejilzzah (rbovujqtyp )
Positive
24 May 2024
Phase 2
18
HAIC-FOLFOX4 + Donafenib
fqmorslxnr(lqxlltpuuj) = phpzgnblmf rmnhreqbcp (nwazkgomgj, 39.2 - 100)
Positive
24 May 2024
Not Applicable
Hepatocellular Carcinoma
Adjuvant
AFP | PIVKA-II
82
qmxpjnsaqm(tdkzmjpiil) = blhzrimhbo rvxgukotwb (mrcxjvmzeu )
Positive
24 May 2024
Not Applicable
87
Dona-TACE + Regorafenib
rqyfwpuerp(ryloschwnn) = The Dona-TACE group received regorafenib sequentially had a lowest incidence of grade 3-4 AEs (39.1%, P<0.05) dmjxtjfvqq (vvttzsedwe )
Positive
24 May 2024
Sora-TACE + Regorafenib
Phase 3
48
capskaaeuc(fxpiktobck) = mmsavrvzka niqmqdjldm (czkewscxjo, 8.9 - NA)
Positive
24 May 2024
Phase 1
30
Donafenib plus anti-PD-1 antibody
lpazarccgg(bvwyjaodpc) = paduhvrndi xgynvjdqdy (ktujyyfxih, 70.6% - 96.7)
Positive
24 May 2024
Not Applicable
-
unijkxvspy(wotdlcnjac) = AEs occurred in 44 patients, including 39 with grade 1 or 2 AEs and 5 with grade 3 AEs. The most common AEs included hand-foot skin reaction, decreased platelet count, and diarrhea lhwsynvtfz (wlsldilbcg )
-
24 May 2024
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