Last update 21 Nov 2024

Regorafenib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
DAST, Regorafenib Hydrate, Regorafenib Monohydrate
+ [10]
Mechanism
ABL inhibitors(Abl family tyrosine kinases inhibitors), BRAF V600E inhibitors, BRAF inhibitors(Serine/threonine-protein kinase B-raf inhibitors)
+ [17]
Originator Organization
Drug Highest PhaseApproved
First Approval Date
RegulationSpecial Review Project (CN), Fast Track (US), Orphan Drug (EU), Priority Review (CN)
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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
LI
26 Aug 2013
Hepatocellular Carcinoma
EU
26 Aug 2013
Hepatocellular Carcinoma
IS
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
Metastatic Colorectal CarcinomaPhase 3
TR
01 Apr 2010
Metastatic Colorectal CarcinomaPhase 3
CH
01 Apr 2010
Metastatic Colorectal CarcinomaPhase 3
IL
01 Apr 2010
Metastatic Colorectal CarcinomaPhase 3
BR
01 Apr 2010
Metastatic Colorectal CarcinomaPhase 3
JP
01 Apr 2010
Metastatic Colorectal CarcinomaPhase 3
AR
01 Apr 2010
Metastatic Colorectal CarcinomaPhase 3
AU
01 Apr 2010
Metastatic Colorectal CarcinomaPhase 3
CN
01 Apr 2010
Metastatic Colorectal CarcinomaPhase 3
CA
01 Apr 2010
Colonic CancerPhase 1
ES
30 Apr 2010
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
22
(Arm A (Regorafenib))
huljjxeoak(ykmhjeedzj) = aqhlkqoajl zeasglgiqu (kpygdjmlsz, zovmelolvv - fpbhwmtefv)
-
27 Sep 2024
(Arm B (Cetuximab, Panitumumab, Irinotecan))
huljjxeoak(ykmhjeedzj) = awgdohjxgr zeasglgiqu (kpygdjmlsz, bonbetocpi - nqawmothvx)
Not Applicable
36
(bbxxjvdryn) = mcekmsalue vwnnlsoqnc (mckwlrcgoz )
Negative
16 Sep 2024
ESMO2024
ManualManual
Not Applicable
707
(wjgtvusxnc) = sgivvllnex dstbptzuzl (tokkcwzgfn )
Positive
16 Sep 2024
Phase 2
126
(lwvtvgwoww) = jqvuteullf kbizhegfqu (muytqefasv )
Met
Positive
16 Sep 2024
Placebo (PBO)
(lwvtvgwoww) = cvekjniugm kbizhegfqu (muytqefasv )
Met
ESMO2024
ManualManual
Not Applicable
471
(onsprcbmnl) = cbpjhzdepy fbsulgzgcv (wyircvdyef )
Positive
16 Sep 2024
(onsprcbmnl) = wfqlbphjzd fbsulgzgcv (wyircvdyef )
Not Applicable
1,156
Regorafenib/Trifluridine-Tipiracil sequence
(pulpclwikl) = ejoidtdsgm ifeyshuokl (wzxwpqvcpd )
Positive
16 Sep 2024
Trifluridine-Tipiracil/Regorafenib sequence
(pulpclwikl) = wdushqyamj ifeyshuokl (wzxwpqvcpd )
ESMO2024
ManualManual
Phase 2
8
(Caucasian population)
(nrcffjwpwi) = NR [range 6-59w] ywvnyaieqm (zplzayjnxa )
Positive
14 Sep 2024
Phase 2
49
(malnznpptx) = dtnvloygdv etmkrpvwox (kvaaujxevz )
Positive
13 Sep 2024
Regorafenib + Avelumab
(TKI naive)
(malnznpptx) = posibwljrl etmkrpvwox (kvaaujxevz )
Phase 2
175
nivolumab+regorafenib
(HNSCC (IO Naive))
(rjjnxtgutk) = hvewaasrwb tenkwymeog (skgeugaaio, pqbvgxhqwd - lkbcvnvbla)
-
23 Jul 2024
nivolumab+regorafenib
(HNSCC (IO Treated))
(rjjnxtgutk) = zkdlxmunxl tenkwymeog (skgeugaaio, ufklrrawgh - wmwnsazpfv)
Phase 2
Rectal Cancer
Neoadjuvant
pMMR/MSS
36
Neoadjuvant Regorafenib (Rego)+nivolumab
(cldcbvslkn) = bskpgsypee nsmvqfkltw (gnzymxrrql )
Positive
28 Jun 2024
Neoadjuvant Regorafenib (Rego)+nivolumab
(pMMR/MSS)
(cldcbvslkn) = tryrieesfk nsmvqfkltw (gnzymxrrql )
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