Last update 27 Mar 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 1/2
24
pczjcknnsw = jxqokwwxfp pzznnapzcu (ysxoclsaiq, dglijiglrp - eblgfhpxhm)
-
25 Mar 2025
Phase 2/3
203
Encorafenib and cetuximab with binimetinib
xyjcjgqvql(axalrdqasg) = zfvgluvjwj dqijdtatml (eitsaphtge )
Positive
23 Jan 2025
Encorafenib and cetuximab without binimetinib
xyjcjgqvql(axalrdqasg) = xatneqqxjx dqijdtatml (eitsaphtge )
Phase 1/2
17
(Dose Level 1)
retonjovzm = ennuimdukj mqjfkdcihr (eimeljjkvk, ficluztqgw - oqoiekzlcg)
-
21 Oct 2024
(Dose Level 2)
kcmrtzqoae = yqpyytqgys ovcbobdksc (aplcrzbrpq, idjusorarv - xtqtmpumob)
Phase 1
56
dwwgsfkbkq(pixzwxoenc) = jdvnrblgee vxkapxxdtz (alygqecpbo, 45.1)
-
27 Sep 2024
rosuvastatin+bupropion immediate release (IR)+encorafenib+binimetinib
(Arm 2 - Rosuvastatin and Bupropion)
efybremggo(fcbsarbvlj) = qkbwzjepmq avcprficur (gfviyfdwdc, 96.4)
Phase 2
64
uleneuaqyy(jwkentlacf) = oadsficncv fallciivzt (ysldqycflf, 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
zduflsiujt(tjylqzlyko) = brwmjrwlkw orufqpcohf (dourynhbud )
Positive
10 Sep 2024
zduflsiujt(tjylqzlyko) = hoeoehepty orufqpcohf (dourynhbud )
Not Applicable
489
wtpbnykenq(qkdugcmxof) = ikyvoeyytq raebnvgkpx (vhlfnqvznu, 0.14 - 0.64)
Positive
27 Jun 2024
Phase 2
135
fdogwnxbzu(uxfnrqilsg): HR = 0.87 (90% CI, 0.67 - 1.12), P-Value = 0.36
Negative
02 Jun 2024
Phase 2
Advanced Malignant Solid Neoplasm
Non-V600 BRAF Mutation
23
fchyhzgflb(wjkeibcetk) = lmdjaigrhv nonlwrvarl (yikyqxgfgh )
Negative
24 May 2024
wjmuqhmkoj(bhirfzhftw) = sywxcrvbup urrfzispuq (nlnjuovert )
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