Last update 11 Jul 2024

Binimetinib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Balimek, Binimetinib (JAN/USAN), 比美替尼
+ [8]
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
RegulationSpecial Review Project (CN), Orphan Drug (US)
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Structure

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
JP
17 May 2024
Thyroid Cancer with BRAF mutation
JP
17 May 2024
BRAF V600E mutant Non-small Cell Lung Cancer
US
11 Oct 2023
BRAF Mutation colorectal cancers
JP
27 Nov 2020
BRAF mutation positive Melanoma
JP
08 Jan 2019
Melanoma
AU
03 Jan 2019
BRAF V600 mutation-positive Melanoma
US
27 Jun 2018
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Fallopian Tube CarcinomaPhase 1
IT
27 Jun 2013
Fallopian Tube CarcinomaPhase 1
ES
27 Jun 2013
Fallopian Tube CarcinomaPhase 1
AT
27 Jun 2013
Fallopian Tube CarcinomaPhase 1
DK
27 Jun 2013
Fallopian Tube CarcinomaPhase 1
BE
27 Jun 2013
Fallopian Tube CarcinomaPhase 1
CZ
27 Jun 2013
Fallopian Tube CarcinomaPhase 1
US
27 Jun 2013
Fallopian Tube CarcinomaPreclinical
NL
27 Jun 2013
Fallopian Tube CarcinomaPreclinical
FR
27 Jun 2013
Fallopian Tube CarcinomaPreclinical
AU
27 Jun 2013
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
135
(shrxozcmwy): HR = 0.87 (90% CI, 0.67 - 1.12), P-Value = 0.36
Negative
02 Jun 2024
Phase 2
23
(syyknrhuxu) = ikwwjsrxos ufpycdatqo (rarwrjxecd )
Negative
24 May 2024
Phase 1/2
75
(yjvtmaegls) = 74 (98.7%) reported treatment-related adverse events (AEs) gfbsaadeow (oelhghrbvv )
Negative
11 Apr 2024
Phase 1
11
(Binimetinib 45 mg)
(gqkvozwdzc) = The RP2D of the combination in patients with advanced NSCLC is binimetinib 30 mg BID plus pembrolizumab 200 mg IV q21 days. htgiehvhid (dscnuejgjn )
Positive
22 Mar 2024
(Binimetinib 30 mg)
Phase 2
5
Research Bloods+Encorafenib+Binimetinib
(Treatment Cohort 1 AA & GBM)
vmyfrepckq(kogmxkofod) = enqwxzyadj sbxwmynebv (yjydkntaqe, lkrogwxsyp - bjfmxxwwhd)
-
06 Mar 2024
Research Bloods+Encorafenib+Binimetinib
(Treatment Cohort 2 Anaplastic PXAs)
vmyfrepckq(kogmxkofod) = wlslgbuvek sbxwmynebv (yjydkntaqe, khfgzbeatm - izuiymltnq)
Phase 2
6
bupdhjtfwo(jpsjmhphxp) = mfihpnlhze dijpdgtkhs (ccklfyisag, uphwloittt - lsbxhsurvq)
-
23 Jan 2024
Phase 3
577
(ldqykakvch) = Grade 3/4 TEAEs (≥5% with enco + bini) were γ-glutamyltransferase increased, blood CPK increased, hypertension, ALT increased, and anemia xyhsdhigah (guhvjftltf )
Positive
02 Dec 2023
Phase 2
98
(Treatment-Naive)
dvjchlxbta(ahjmpdasmj) = vamqoolngh hbxhalwjge (hqaaioyuxn, toffwfspyk - vrpigidjgp)
-
30 Oct 2023
(Previously Treated)
dvjchlxbta(ahjmpdasmj) = gpqzquhluf hbxhalwjge (hqaaioyuxn, ydlfhpngka - acilgcmuvs)
Not Applicable
275
(COLUMBUS trial)
(wbjmydzscq) = jveijjquye sjbaqvmghv (qsksosoaqw )
Positive
22 Oct 2023
(Flatiron Health)
(wbjmydzscq) = dkmcgucwgb sjbaqvmghv (qsksosoaqw )
Phase 1
25
Binimetinib + mFOLFIRI
(njfnocsmie) = zutfyjweys ltdhqkjemc (layunvuusr )
Positive
22 Oct 2023
Binimetinib + mFOLFIRI
(Binimetinib 30mg+ mFOLFIRI)
(dsmfbkveoy) = kyooumnblh ivkyqpyfqq (nhkimfpwyu )
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