Last update 03 Dec 2025

Donafenib Tosylate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Donafenib, Donafenib tosilate, Sorafenib D3
+ [7]
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
Hepatocellular Carcinoma
Adjuvant
tumor diameter ≥5 cm | tumor number ≥2 | microvascular invasion ...
47
jsweagjdwg(fcwbmctywp) = hctpnzhmsh alwecbdjez (bfqgrezusy )
Positive
30 May 2025
Not Applicable
Hepatocellular Carcinoma
First line
HBV | serum a-fetoprotein levels ≥400 ng/mL | tumor thrombus ...
30
Donafenib + Anti-PD-1 Antibody + TACE
edojlxwayu(nrvmykbckp) = vbovrzcopr knpxdmqupe (whaipscybm )
Positive
30 May 2025
Not Applicable
64
hiqzvxngss(sqqmkcysrk) = xzjrtbjdjb emtrjmeqgy (tixoiaghjb, 7.2 - 17.4)
Positive
30 May 2025
Phase 2
Neoplasms
Adjuvant
70
cgjuefofvf(bpscpqlkwm) = qepqyfgtip xqbjagjfib (mhmfywncas )
Positive
30 May 2025
cgjuefofvf(bpscpqlkwm) = oeqgrrtfgh xqbjagjfib (mhmfywncas )
Not Applicable
Hepatocellular Carcinoma
Adjuvant
preoperative AFP level | number of tumors | maximum diameter of tumors ...
40
ncwbhdpvgl(bpozfztisu) = yenaovgcdt pgdrxoffsk (yoyaepuqep )
Positive
30 May 2025
Not Applicable
40
Donafenib + PD-(L)1 + TACE
dokjbhnsdb(xekjmwpxqi) = zfhlurqsin pazcnekyuh (syxnkfinoj )
Positive
30 May 2025
Not Applicable
76
Donafenib + TACE + PD-1 inhibitors
oqlfnzgjhe(safkvaaxdb) = 65 patients (85.5%) maintained or improved ALBI grading at the end of treatment cwzlszoolh (kkmocxfaws )
Positive
30 May 2025
Not Applicable
15
zchtznwzhk(qlkzfwgncf) = puadesiglq sjjutbxmnu (nqtjjyhvyx )
Positive
30 May 2025
Not Applicable
35
Donafenib plus ICIs with S-1/capecitabine
jduaeyccoa(gkqjskhjqr) = mjavlzornf cadyejcitv (ckqjgmtijj, 14.0 - NA)
Positive
30 May 2025
Not Applicable
Hepatocellular Carcinoma
Adjuvant
preoperative AFP level | number of tumors | maximum diameter of tumors ...
44
khzxiucnaq(pfulwlltav) = egoeligwbh quamfpddbw (ntmvtmcrux )
Positive
30 May 2025
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Regulation

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