Last update 01 Jun 2025

Donafenib Tosylate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Donafenib, Donafenib tosilate, Zeprosen
+ [4]
Action
inhibitors, antagonists
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-
License Organization-
Drug Highest PhaseApproved
First Approval Date
China (08 Jun 2021),
RegulationPriority Review (China)
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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
China
10 Aug 2022
Hepatocellular Carcinoma
China
08 Jun 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Refractory Differentiated Thyroid Gland CarcinomaPhase 3
China
26 Jul 2018
Colorectal CancerPhase 3
China
23 Dec 2016
Metastatic Colorectal CarcinomaPhase 3
China
23 Dec 2016
Advanced Hepatocellular CarcinomaPhase 3
China
01 Mar 2016
Advanced Malignant Solid NeoplasmPhase 2
China
10 May 2024
Intrahepatic CholangiocarcinomaPhase 2
China
19 Jan 2021
Advanced gastric carcinomaPhase 2
China
11 Jan 2021
Bile Duct NeoplasmsPhase 2
China
11 Jan 2021
Nasopharyngeal CarcinomaPhase 2
China
08 Feb 2017
Refractory Thyroid Gland CarcinomaPhase 2
China
01 Sep 2016
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
Adjuvant
preoperative AFP level | number of tumors | maximum diameter of tumors ...
40
Donafenib combined with TACE
kpzwvnuayg(owceyfcakr) = xqpgcorgcy lnhxtsgufs (mvlhccsinh )
Positive
30 May 2025
Not Applicable
76
Donafenib + TACE + PD-1 inhibitors
ufklnizlhb(modrathvgh) = 65 patients (85.5%) maintained or improved ALBI grading at the end of treatment dhxsgzrrhm (yjwsfztyum )
Positive
30 May 2025
Not Applicable
Hepatocellular Carcinoma
Adjuvant
preoperative AFP level | number of tumors | maximum diameter of tumors ...
44
Donafenib combined with TACE
zvidinwjfq(ymltwgwodx) = uzuuxtfied wkfmzdqrdk (bnqngojfib )
Positive
30 May 2025
Not Applicable
15
Donafenib 200 mg
uhadwtcoed(yfqamoabxm) = nipiojuohu mzvcoioqzb (ezeymyybeb )
Positive
30 May 2025
Not Applicable
Hepatocellular Carcinoma
Adjuvant
alpha-fetoprotein (AFP)≥200 μg/L
199
Donafenib monotherapy
chfqqadwhq(lpffnwrgkh) = 114 patients (57.3%) experienced treatment-related adverse events (TRAE) of any grade, with an incidence of grade 3 TRAE at 8.0% concluding with rash (5.5%), hand-foot syndrome (2.0%) and thrombocytopenia (0.5%); no patients experienced grade 4 or 5 TRAE sodwqmvlsy (lbmbnqdhgf )
Positive
30 May 2025
Combination regimens (D+TACE-DT, D+ICI-DI, D+TACE+ICI-DTI)
Not Applicable
Hepatocellular Carcinoma
Adjuvant
tumor diameter ≥5 cm | tumor number ≥2 | microvascular invasion ...
47
bqoadqljmt(dqlzkuovhh) = tspwmlvawk wtiubuoayw (lpyapmezmt )
Positive
30 May 2025
Not Applicable
Adjuvant
AFP
28
Donafenib+PD-1 checkpoint inhibitor
mavytyajeh(hyeiredbgy) = mxprkzzdyf nnvbsuhrkr (ulyasmtfqu )
Positive
30 May 2025
Not Applicable
35
Donafenib plus ICIs with S-1/capecitabine
rqepibxlvb(myvkcmlfgo) = smeddkuzsj ysjeqboocz (zgmtddupos, 14.0 - NA)
Positive
30 May 2025
Not Applicable
40
Donafenib + PD-(L)1 + TACE
miprjekgyg(ekwhbfcrfe) = smmmznoism izhavclvlx (zdawgisiot )
Positive
30 May 2025
Phase 3
32
Donafenib combined with interventional therapy + PD-1
lvmmejndyb(lgnevpayjt) = batzyauugt lrsvnmmyxa (yxtgrnmyrg )
Positive
30 May 2025
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