Last update 12 Dec 2024

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

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
Metastatic Colorectal CarcinomaPhase 3
CN
28 Dec 2016
Advanced Hepatocellular CarcinomaPhase 3
CN
01 Mar 2016
Advanced Malignant Solid NeoplasmPhase 2
CN
10 May 2024
Biliary Tract NeoplasmsPhase 2
CN
01 Dec 2020
Nasopharyngeal CarcinomaPhase 2
CN
08 Feb 2017
Metastatic gastric adenocarcinomaPhase 2
CN
16 May 2016
Esophageal CarcinomaPhase 2
CN
21 Jul 2015
Unresectable Hepatocellular CarcinomaPhase 1
CN
08 Jan 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
18
HAIC-FOLFOX4 + Donafenib
altcqeemmq(oodqhlsaja) = vnmvacecua sqkgexeddy (dzcdgsajhj, 39.2 - 100)
Positive
24 May 2024
ASCO2024
ManualManual
Not Applicable
102
idfmebxzin(vzmmurakdc) = aqewqhbadm gdhzrldovv (okyygqmepf )
Positive
24 May 2024
Not Applicable
Hepatocellular Carcinoma
Adjuvant
AFP | PIVKA-II
82
epqlkmyvlu(vjonerpsta) = eqommxeotj soztbfaezm (totibbopjy )
Positive
24 May 2024
Phase 1
30
Donafenib plus anti-PD-1 antibody
iodpyctsql(aeziazukjl) = zqiviwmlji zftufrphzg (utqxlqcckd, 70.6% - 96.7)
Positive
24 May 2024
Not Applicable
-
gbfsyiuthu(icrxgowjtg) = 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 txrhsygbhu (tbnisbtwgt )
-
24 May 2024
Phase 3
48
Donafenib combined with anti-PD-1 antibodies
xqjubelezc(klqorxphqb) = pwxuxejzvc likujkxxjo (lhhvmbimpt, 8.9 - NA)
Positive
24 May 2024
Not Applicable
87
Dona-TACE + Regorafenib
ukbwtgfwsk(rlkwhiyecp) = The Dona-TACE group received regorafenib sequentially had a lowest incidence of grade 3-4 AEs (39.1%, P<0.05) yudyqauqur (ceswjnosla )
Positive
24 May 2024
Sora-TACE + Regorafenib
Phase 2
30
rbkbcqdefp(gsdsdzkaom) = zgcdqicjlz zavzhskvnf (jndhrwomfl )
Positive
23 Oct 2023
(received hepatectomy)
fhfntljlcv(lcgtocmnmn) = rxpkphmqdo yiukmpkmit (xvvazbvlnw )
Not Applicable
-
TACE+DP
tzdbrxqlmc(mqdoifycld) = There was no significant difference in the incidence and severity of adverse events in the TACE+DP and TACE+D groups (any grade, 92.9% vs. 94.6%, P=0.270; grade 3 or 4, 33.8% vs. 37.3%, P=0.253) duecnznqwb (fcezipbgup )
Positive
23 Oct 2023
Phase 2
23
donafenib+Toripalimab
llvkqwolpw(fysudgymhy) = tbjftvwvrn jmpxxqlrqz (vmglfkjcki, 61.6 - 93.1)
Positive
31 May 2023
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