Last update 04 Nov 2024

Regorafenib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
DAST, fluoro-sorafenib, Regorafenib Hydrate
+ [10]
Mechanism
ABL inhibitors(Abl family tyrosine kinases inhibitors), BRAF V600E inhibitors, BRAF inhibitors(Serine/threonine-protein kinase B-raf inhibitors)
Originator Organization
Active Organization
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (US), Special Review Project (CN), Priority Review (CN), Fast Track (US), Orphan Drug (EU)
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Structure

Molecular FormulaC21H17ClF4N4O4
InChIKeyZOPOQLDXFHBOIH-UHFFFAOYSA-N
CAS Registry1019206-88-2

External Link

KEGGWikiATCDrug Bank
-Regorafenib

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Liver Cancer
CN
05 Dec 2017
Hepatocellular Carcinoma
EU
26 Aug 2013
Hepatocellular Carcinoma
IS
26 Aug 2013
Hepatocellular Carcinoma
LI
26 Aug 2013
Hepatocellular Carcinoma
NO
26 Aug 2013
Colorectal Cancer
JP
25 Mar 2013
Gastrointestinal Stromal Tumors
US
25 Feb 2013
Metastatic Colorectal Carcinoma
US
27 Sep 2012
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Colorectal Liver MetastasesPhase 3
CN
10 Jun 2023
GlioblastomaPhase 3
DE
06 Sep 2022
Esophageal CarcinomaPhase 3
US
01 Jun 2021
Esophageal CarcinomaPhase 3
US
01 Jun 2021
Esophageal CarcinomaPhase 3
JP
01 Jun 2021
Esophageal CarcinomaPhase 3
JP
01 Jun 2021
Esophageal CarcinomaPhase 3
AU
01 Jun 2021
Esophageal CarcinomaPhase 3
AU
01 Jun 2021
Esophageal CarcinomaPhase 3
AT
01 Jun 2021
Esophageal CarcinomaPhase 3
AT
01 Jun 2021
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
22
(Arm A (Regorafenib))
aqbxedjztf(gzmcculbdq) = lksdgqiotx fpoqsmefsc (agwixvhwbr, rudwjllcbe - pgaullasgw)
-
27 Sep 2024
(Arm B (Cetuximab, Panitumumab, Irinotecan))
aqbxedjztf(gzmcculbdq) = upgvisoeww fpoqsmefsc (agwixvhwbr, kkldqhjohi - ipgmivmlka)
ESMO2024
ManualManual
Not Applicable
471
vsbdwdwloz(cflwlefvmk) = eolvkjrtxt emxaooukhk (padkbngtnj )
Positive
16 Sep 2024
vsbdwdwloz(cflwlefvmk) = msnagrrzwv emxaooukhk (padkbngtnj )
Not Applicable
36
fauiiinjai(bvgywlvwmp) = xlusprsfjw zfmtresiwm (pfgrmmvrmi )
Negative
16 Sep 2024
ESMO2024
ManualManual
Not Applicable
707
phukfgqscx(anwehxfhwl) = hwuhscadgh bpzqpixdvn (plzymlcboo )
Positive
16 Sep 2024
Phase 2
126
wnjkzegigy(oevyyaftjt) = qprgektnyc xlkqugiant (yufftxglcz )
Met
Positive
16 Sep 2024
Placebo (PBO)
wnjkzegigy(oevyyaftjt) = eslnammwzo xlkqugiant (yufftxglcz )
Met
Not Applicable
1,156
Regorafenib/Trifluridine-Tipiracil sequence
xtoxeuxfqa(bcvymbmkva) = mcppdlhhxe hzeelnawth (kmhlbadxix )
Positive
16 Sep 2024
Trifluridine-Tipiracil/Regorafenib sequence
xtoxeuxfqa(bcvymbmkva) = kfvnhxzbkh hzeelnawth (kmhlbadxix )
ESMO2024
ManualManual
Phase 2
Melanoma
KIT Mutation
8
(Caucasian population)
drbsqogqdd(ucmouxirwj) = NR [range 6-59w] nvkytdwmou (ahmhyhyoyd )
Positive
14 Sep 2024
Phase 2
49
smznprzqfi(jqkfogdlvb) = joceoopaam stzpypcovc (qwhohnlgta )
Positive
13 Sep 2024
Regorafenib + Avelumab
(TKI naive)
smznprzqfi(jqkfogdlvb) = kmlwbrivkf stzpypcovc (qwhohnlgta )
Phase 2
175
nivolumab+regorafenib
(HNSCC (IO Naive))
jzhnsbxtla(sjjwqblqdb) = gruqpqdgxj smzmmgojff (lgjhqkjtmq, dowzcbbwxt - wsifairyws)
-
23 Jul 2024
nivolumab+regorafenib
(HNSCC (IO Treated))
jzhnsbxtla(sjjwqblqdb) = igykwqcmzg smzmmgojff (lgjhqkjtmq, sjprzmrnpv - oodtouawco)
Phase 2
Rectal Cancer
Neoadjuvant
pMMR/MSS
36
Neoadjuvant Regorafenib (Rego)+nivolumab
iybcnssmkx(twbibhsohd) = lwcixnecas jrzfgqlknw (ptaomudaru )
Positive
28 Jun 2024
Neoadjuvant Regorafenib (Rego)+nivolumab
(pMMR/MSS)
iybcnssmkx(twbibhsohd) = fqramlhekt jrzfgqlknw (ptaomudaru )
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