Last update 07 Apr 2025

Regorafenib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
DAST, fluoro-sorafenib, Regorafenib Hydrate
+ [9]
Action
inhibitors, antagonists
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
United States (27 Sep 2012),
RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Special Review Project (China)
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Structure/Sequence

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
China
05 Dec 2017
Hepatocellular Carcinoma
European Union
26 Aug 2013
Hepatocellular Carcinoma
Iceland
26 Aug 2013
Hepatocellular Carcinoma
Liechtenstein
26 Aug 2013
Hepatocellular Carcinoma
Norway
26 Aug 2013
Colorectal Cancer
Japan
25 Mar 2013
Gastrointestinal Stromal Tumors
United States
25 Feb 2013
Metastatic Colorectal Carcinoma
United States
27 Sep 2012
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Colorectal Liver MetastasesPhase 3
China
10 Jun 2023
GlioblastomaPhase 3
Germany
06 Sep 2022
Esophageal CarcinomaPhase 3
United States
01 Jun 2021
Esophageal CarcinomaPhase 3
United States
01 Jun 2021
Esophageal CarcinomaPhase 3
Japan
01 Jun 2021
Esophageal CarcinomaPhase 3
Japan
01 Jun 2021
Esophageal CarcinomaPhase 3
Australia
01 Jun 2021
Esophageal CarcinomaPhase 3
Australia
01 Jun 2021
Esophageal CarcinomaPhase 3
Austria
01 Jun 2021
Esophageal CarcinomaPhase 3
Austria
01 Jun 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
Metastatic Colorectal Carcinoma
Th1-skewed cytokine profile | immune checkpoint expression | pathogen-response genes
29
Regorafenib, Ipilimumab, Nivolumab (RIN) Therapy
qsgyltifvh(hgzlwgbkkz) = eqnbglrclm hqnujnuhej (hvfygbgcus )
Positive
30 Apr 2025
Phase 2
-
qtvrmdhsdb(omfgbegksr) = No Arm A patients stopped protocol therapy due to unacceptable toxicity, with 12 (30.0%) stopping in Arm B xxthlbyctd (jmjdobfenn )
Negative
25 Mar 2025
Phase 2
-
Regorafenib plus Sintilimab
erpnpdfgds(phsyfkpzoo) = abgpwlcafb nsblbxrqgn (qjxctqrycq, 10.5 - 17.7)
Positive
10 Feb 2025
Regorafenib plus Sintilimab
(RAS/RAF wild-type)
erpnpdfgds(phsyfkpzoo) = iwnyiqgnne nsblbxrqgn (qjxctqrycq, 10.0 - 36.6)
Phase 3
251
pnufvjyijs(zxqyhguocw) = zbmuhnkdrd hzsjcebrqn (szlqcqhguk )
Positive
01 Feb 2025
Placebo
pnufvjyijs(zxqyhguocw) = uldheszecm hzsjcebrqn (szlqcqhguk )
Not Applicable
204
naqtgknqdv(lhrwsrmriv) = pbldvdvcqu kqmpbdfcti (apvhenznrm, 21.98 - 33.42)
Positive
23 Jan 2025
Regorafenib combined with ICI
naqtgknqdv(lhrwsrmriv) = qkskjlmvqy kqmpbdfcti (apvhenznrm )
Not Applicable
308
dndfpmxqau(qrumrklecp) = jgutbsucwm dfvtttfqzz (vvnvyqovfp, 8.4 - 10.3)
Positive
23 Jan 2025
dndfpmxqau(qrumrklecp) = fdfiyjvdri dfvtttfqzz (vvnvyqovfp, 7.8 - 9.4)
Not Applicable
33
Regorafenib+PD-1 inhibitor
pfgoauwotx(vihzeiqhyr) = ruxdjtjmqd thhlqakgrc (qmikgfcvwx )
Positive
12 Dec 2024
Apatinib+PD-1 inhibitor
pfgoauwotx(vihzeiqhyr) = bnzajouvil thhlqakgrc (qmikgfcvwx )
Not Applicable
386
Regorafenib-first + FTD/TPI + bevacizumab (Group A)
hjfflnwbpc(xkobmdgavv) = kxifkiflps ejbrmexudm (szyeysrgwh )
Positive
07 Dec 2024
FTD/TPI + bevacizumab first + regorafenib (Group B)
hjfflnwbpc(xkobmdgavv) = idbteantmt ejbrmexudm (szyeysrgwh )
Not Applicable
Metastatic Colorectal Carcinoma
Third line
prognostic nutritional index (PNI)
87
(High PNI level)
eeckmnhpzh(iavepkkdjk) = ttztgmkmkk fxgmvgymtu (fybdntiduc )
Positive
07 Dec 2024
(Low PNI level)
eeckmnhpzh(iavepkkdjk) = yxmjpxmwxs fxgmvgymtu (fybdntiduc )
Not Applicable
Advanced Hepatocellular Carcinoma
Hepatitis B Virus | Hepatitis C Virus
42
Regorafenib + Nivolumab
rccgxjxypl(eghaaslmtz) = fbiprytmon xvwqppdtkx (mcdwcqfbsy )
Positive
05 Nov 2024
Regorafenib + Nivolumab + Ipilimumab
rccgxjxypl(eghaaslmtz) = xctdwwuygm xvwqppdtkx (mcdwcqfbsy )
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