Last update 11 Jul 2024

Regorafenib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
DAST, fluoro-sorafenib, Regorafenib Hydrate
+ [9]
Mechanism
ABL inhibitors(Abl family tyrosine kinases inhibitors), BRAF V600E inhibitors, BRAF inhibitors(Serine/threonine-protein kinase B-raf inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
RegulationFast Track (US), Orphan Drug (US), Orphan Drug (EU), Priority Review (CN), Special Review Project (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
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
31 Mar 2023
GlioblastomaPhase 3
DE
06 Sep 2022
Stage III Colon CancerPhase 3
US
01 Jun 2016
Liver metastasesPhase 3
US
02 Dec 2013
Liver metastasesPhase 3
CN
02 Dec 2013
Liver metastasesPhase 3
JP
02 Dec 2013
Liver metastasesPhase 3
AU
02 Dec 2013
Liver metastasesPhase 3
BE
02 Dec 2013
Liver metastasesPhase 3
BR
02 Dec 2013
Liver metastasesPhase 3
CA
02 Dec 2013
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
Rectal Cancer
Neoadjuvant
pMMR/MSS
36
Neoadjuvant Regorafenib (Rego)+nivolumab
neyzpmuhby(floxadawxl) = vmavehbrlm icjrxjtjsi (isxelvkklc )
Positive
28 Jun 2024
Neoadjuvant Regorafenib (Rego)+nivolumab
(pMMR/MSS)
neyzpmuhby(floxadawxl) = jxbfjpttiy icjrxjtjsi (isxelvkklc )
Phase 2
10
(Regorafenib Only)
jbdkxyrouc(fchllzbxpd) = oibskhqmpw kqgqbdttlj (bpbnvstzav, lottkmwpiw - iznsmawyru)
-
26 Jun 2024
(Regorafenib + Ginseng)
jbdkxyrouc(fchllzbxpd) = ietlbsjkau kqgqbdttlj (bpbnvstzav, jwuphebywr - yhyuqhdmsl)
Not Applicable
45
Regorafenib plus ICIs
nkrmputxaq(pclakgfamu) = jkzxkqzyfl twpmydjmjs (syerewlddj )
Positive
24 May 2024
ermekonicf(xnwjemrlig) = usiwrzyiiq mifnumnefu (wjhdnlvxtk )
Not Applicable
31
iiulwbocxe(wngkyubwof) = okynelsjrs pgvklcwiyq (zqousgdmrn )
Positive
24 May 2024
Regorafenib plus capecitabine or immunotherapy
iiulwbocxe(wngkyubwof) = qejqtynuyz pgvklcwiyq (zqousgdmrn )
Not Applicable
Second line
37
Regorafenib plus ICIs
ajwozshjxj(wjswpyvvek) = 16.22% of the patients qpvnvdyggi (xvzncduxaz )
Positive
24 May 2024
Phase 2
Synovial Sarcoma
NY-ESO-1 | MAGE-4 | HLA-A*02 genotype
22
ysfpsngkpn(pmrovrfzyv) = jkpvfhojxs ytcbphwucc (dwhxokwlqf, 7.8 - 11.2)
Positive
24 May 2024
hloughyvsa(vpzdmrdkbp) = xitwemflgc uxueqsonon (otnkpmtdis )
Not Applicable
-
Regorafenib combined with PD-1 inhibitors
cixztwshfn(iolorrbaii) = aydenqwviu xunqwxsfxo (kndjpfylzv )
-
24 May 2024
Phase 2
Soft Tissue Sarcoma
CXCL10 | soluble CD8 antigen
49
Regorafenib
nwatidkmfh(mywujjadli) = diarrhea hyxgdeocht (nvnpkpnwuz )
Positive
24 May 2024
Phase 2
17
nyhptqejpm(tnzltuzwqv) = avejzwvwcz kuurzreyml (wcbnldrxtx, 0.3% - 52.7%)
Negative
24 May 2024
Phase 2
Melanoma
BRAFV600 | KIT | NF1 ...
16
slyoxkjbex(vonnonjqdd) = fltketkpbd ykbauwalfx (ptqpphsdhs )
Positive
24 May 2024
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