Last update 03 Jul 2025

Encorafenib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Encorafenib (JAN/USAN/INN), 康奈非尼, 恩可非尼
+ [9]
Action
inhibitors
Mechanism
BRAF V600E inhibitors
Originator Organization
Drug Highest PhaseApproved
RegulationAccelerated Approval (United States), Orphan Drug (United States), Orphan Drug (South Korea), Priority Review (Australia)
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Structure/Sequence

Molecular FormulaC22H27ClFN7O4S
InChIKeyCMJCXYNUCSMDBY-ZDUSSCGKSA-N
CAS Registry1269440-17-6

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
BRAF mutated anaplastic thyroid cancer
Japan
17 May 2024
Thyroid Cancer with BRAF mutation
Japan
17 May 2024
BRAF V600E mutant Non-small Cell Lung Cancer
United States
11 Oct 2023
BRAF mutation positive Melanoma
Japan
27 Nov 2020
BRAF Mutation colorectal cancers
Japan
08 Jan 2019
BRAF V600 mutation-positive Melanoma
European Union
19 Sep 2018
BRAF V600 mutation-positive Melanoma
Iceland
19 Sep 2018
BRAF V600 mutation-positive Melanoma
Liechtenstein
19 Sep 2018
BRAF V600 mutation-positive Melanoma
Norway
19 Sep 2018
BRAF V600E mutant Colorectal Cancer
European Union
19 Sep 2018
BRAF V600E mutant Colorectal Cancer
Iceland
19 Sep 2018
BRAF V600E mutant Colorectal Cancer
Liechtenstein
19 Sep 2018
BRAF V600E mutant Colorectal Cancer
Norway
19 Sep 2018
BRAF V600E Mutation-Positive Melanoma
United States
27 Jun 2018
BRAF V600K Mutation-Positive Melanoma
United States
27 Jun 2018
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
MelanomaPhase 3
Argentina
02 May 2022
MelanomaPhase 3
Australia
02 May 2022
MelanomaPhase 3
Austria
02 May 2022
MelanomaPhase 3
Belgium
02 May 2022
MelanomaPhase 3
Brazil
02 May 2022
MelanomaPhase 3
Canada
02 May 2022
MelanomaPhase 3
Czechia
02 May 2022
MelanomaPhase 3
France
02 May 2022
MelanomaPhase 3
Germany
02 May 2022
MelanomaPhase 3
Greece
02 May 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
First line
271
Encorafenib 450 mg + Binimetinib 45 mg
cmivefkehw(edhpjakadz) = Grade 3-5 treatment-related adverse events occurred in 57 (42%) of 136 patients who started treatment in the Encorafenib 450 mg + Binimetinib 45 mg group and in 42 (32%) of 131 patients who started treatment in the Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg group daowoqpwea (dhzdmlvwry )
Negative
01 Jun 2025
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
Phase 3
637
usayhchobg(ohnkezpfgz) = ycmrcawrnp vbtpasbsyg (mhykjfoxcl, 5.7 - 8.3)
Positive
30 May 2025
encorafenib + cetuximab + mFOLFOX6
usayhchobg(ohnkezpfgz) = xgyfmnhtpv vbtpasbsyg (mhykjfoxcl, 11.2 - 15.9)
Phase 3
-
lbkrfklvvr(mqmaiithwm) = The incidence of serious adverse events during treatment was 46.1% with EC+mFOLFOX6 and 38.9% with standard care gaifwhouvd (ybqmpjirpf )
Positive
30 May 2025
Standard care (chemotherapy with or without bevacizumab)
Phase 2
48
Radiosurgery/stereotactic radiosurgery+Encorafenib+Binimetinib
srybwiwezm(vzvpndhido) = dpndhvjfls wwfztpscfb (ylgwwtnioo, ogbwoojjgt - gtmgnljker)
-
13 May 2025
Phase 3
479
qakvwxepmn(gieaofacyv) = iezzwiubfe irxlvzdduq (ekngejkgdx, 51.6 - 69.5)
Positive
23 Jan 2025
Standard of Care (chemo with or without bevacizumab)
qakvwxepmn(gieaofacyv) = isjnihittk irxlvzdduq (ekngejkgdx, 31.3 - 49.3)
Phase 2
20
Cetuximab every second week + Encorafenib
ikmqwutgxh(zpcqtmmtcl) = gvubhnaebk pgbrwuvtnu (lwxhmyfkit )
Positive
23 Jan 2025
Phase 2/3
203
Encorafenib and cetuximab with binimetinib
vogwpvbixt(ilhsovwgzc) = outavwngtd oerxhshfid (famgqvbedo )
Positive
23 Jan 2025
Encorafenib and cetuximab without binimetinib
vogwpvbixt(ilhsovwgzc) = ikrheklbjx oerxhshfid (famgqvbedo )
Phase 1/2
17
(Dose Level 1)
rxcgjaeiic = wsqjjedkmf tebhhpaahx (rybwgohugd, eltcevrkgq - iutymbtsrf)
-
21 Oct 2024
(Dose Level 2)
urnzehpjvg = fgtzxzfspq wktpsntslc (sigaxkcszz, pwmmxfosjd - goxllfnygh)
Phase 1
56
zdrkzdbdic(uzzqnsounk) = smnpolsqta kbairysisl (eajaygzdie, 45.1)
-
27 Sep 2024
(Arm 2 - Rosuvastatin and Bupropion)
mxvqzqlmww(swtfmbebiy) = gfajjueouc qonigupukk (sarisqxwup, 96.4)
Phase 2
64
nlxqitgxdg(dbkwyfdwoe) = jwrnpoyocy srgbnnsmxu (itxrjhrmoo, 55.0 - 78.3)
Positive
14 Sep 2024
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