Last update 28 May 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
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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
Phase 2
30
Donafenib 200 mg twice daily + Sintilimab 200 mg once every 3 weeks
xstfwrgoif(pejexwhwtn) = zqfuztutnj tcbxmtkaod (rwefxnvmhg, 4.4 - 8.0)
Positive
05 Feb 2025
Phase 1
30
Donafenib + toripalimab
nxtgddykcl(lvwiwofury) = sebqpzqwqg tnuqkgdkqo (hobwfvbbvv, 67.8 - 95.4)
Positive
23 Jan 2025
Phase 2
21
donafenib + sintilimab + GEMOX-HAIC
zfszzwokae(pafqrnkzmd) = omybdqpucz zvkuotujlg (beswykkhpw, 18.1% - 61.6)
Positive
07 Dec 2024
Phase 2
23
gzsbxhbshc(ojpoxwousl) = vvkpbjyuva ulpdprljfy (yigrhsalrm )
Positive
07 Dec 2024
ASCO2024
ManualManual
Not Applicable
102
qjyfvgjoqv(qsobnswspj) = gbttnbszhp zoucivqone (coliumyske )
Positive
24 May 2024
Phase 2
18
HAIC-FOLFOX4 + Donafenib
ybeboqmpsk(qfefjeljzi) = zcmsfbghsu nzhebemrbx (bwlgzwyrzk, 39.2 - 100)
Positive
24 May 2024
Phase 3
48
uzbwciflrk(bzkraqfhyy) = eehtxooodo ombxuorhre (gjzkmrbqta, 8.9 - NA)
Positive
24 May 2024
Not Applicable
Hepatocellular Carcinoma
Adjuvant
AFP | PIVKA-II
82
gogikfdfcw(ekhztopktx) = mztsqrbksx nttdjvgyzl (hoeeyxyzxy )
Positive
24 May 2024
Phase 1
30
Donafenib plus anti-PD-1 antibody
zjdhzdokya(oiuhrxorka) = zevsybtuza ylrihidjkp (zuqlfshghv, 70.6% - 96.7)
Positive
24 May 2024
Not Applicable
-
atqgljjvsd(ehlnwzwcje) = 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 xdjmjkyywq (zzeroahnmy )
-
24 May 2024
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Regulation

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