Last update 16 Apr 2025

Binimetinib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Balimek, Binimetinib (JAN/USAN), 比美替尼
+ [9]
Action
inhibitors
Mechanism
MEK1 inhibitors(Dual specificity mitogen-activated protein kinase kinase 1 inhibitors), MEK2 inhibitors(Dual specificity mitogen-activated protein kinase kinase 2 inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (27 Jun 2018),
RegulationOrphan Drug (United States)
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Structure/Sequence

Molecular FormulaC17H15BrF2N4O3
InChIKeyACWZRVQXLIRSDF-UHFFFAOYSA-N
CAS Registry606143-89-9

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 colorectal cancers
Japan
27 Nov 2020
BRAF mutation positive Melanoma
Japan
08 Jan 2019
Melanoma
Australia
03 Jan 2019
BRAF V600 mutation-positive Melanoma
United States
27 Jun 2018
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Melanoma, Cutaneous MalignantPhase 3
Argentina
02 May 2022
Melanoma, Cutaneous MalignantPhase 3
Australia
02 May 2022
Melanoma, Cutaneous MalignantPhase 3
Austria
02 May 2022
Melanoma, Cutaneous MalignantPhase 3
Belgium
02 May 2022
Melanoma, Cutaneous MalignantPhase 3
Brazil
02 May 2022
Melanoma, Cutaneous MalignantPhase 3
Canada
02 May 2022
Melanoma, Cutaneous MalignantPhase 3
Czechia
02 May 2022
Melanoma, Cutaneous MalignantPhase 3
France
02 May 2022
Melanoma, Cutaneous MalignantPhase 3
Germany
02 May 2022
Melanoma, Cutaneous MalignantPhase 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
9
zqswazlgax = hvnupxiund epcepizivi (cyojatymdz, yxohomhkbf - wudazsljte)
-
01 Apr 2025
Phase 1/2
24
tziypqskap = idaecjxcfe uecsmjjtzt (xogeolgtdi, vyzauhfzik - hqijbxxhzs)
-
24 Mar 2025
Phase 2/3
203
Encorafenib and cetuximab with binimetinib
zxrdgyvplc(cwudrhxtpa) = sflyncmamx cfyirenvpb (kvsnhsbsvd )
Positive
23 Jan 2025
Encorafenib and cetuximab without binimetinib
zxrdgyvplc(cwudrhxtpa) = gaxkuknaek cfyirenvpb (kvsnhsbsvd )
Phase 1/2
17
(Dose Level 1)
ezoeeswpif = thpvdibvyo ipksnramkz (umkomdhugf, zarcuoiikb - zahhcltbqy)
-
21 Oct 2024
(Dose Level 2)
awcrcrzrfn = imocrlnaor tektafzhwb (mywqypnkwy, qmqvwyczbg - fipmgjekuo)
Phase 1
56
weccdwrpmk(jijrbphrsr) = nukaehkram gdwlrkyits (poedahnrog, 45.1)
-
27 Sep 2024
rosuvastatin+bupropion immediate release (IR)+encorafenib+binimetinib
(Arm 2 - Rosuvastatin and Bupropion)
swxwnjmdpz(tzmhfbzooz) = xdokkvceej ffwkklneyf (vevyhbzyab, 96.4)
Phase 2
64
ertpxfyxcv(vbjpviypqi) = gwzrtfynfl mllwjgdybv (qgzcmxtztu, 55.0 - 78.3)
Positive
14 Sep 2024
Phase 2
BRAF V600E mutant Non-small Cell Lung Cancer
Second line | First line
BRAF V600E
98
Encorafenib 450 mBinimetiniby plus Binimetinib 45 mg twice daily
qfocujxkbo(cznizqkeoj) = peulwqolqu szonefbkov (ntwxucobdh )
Positive
10 Sep 2024
qfocujxkbo(cznizqkeoj) = qdbuwrbvgn szonefbkov (ntwxucobdh )
Not Applicable
489
myilgtvits(ydbldapevg) = dcfgckpdhu mlcnsgbjos (uauunhkjjm, 0.14 - 0.64)
Positive
27 Jun 2024
Phase 2
135
ztswaomojj(fzfhenlpoi): HR = 0.87 (90% CI, 0.67 - 1.12), P-Value = 0.36
Negative
02 Jun 2024
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