Last update 23 Jan 2025

Binimetinib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Balimek, Binimetinib (JAN/USAN), 比美替尼
+ [9]
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/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
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 positive Melanoma
JP
08 Jan 2019
Melanoma
AU
03 Jan 2019
BRAF V600 mutation-positive Melanoma
CA
-
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Recurrent Primary Peritoneal Low Grade Serous AdenocarcinomaPreclinical
AU
27 Jun 2013
Recurrent Primary Peritoneal Low Grade Serous AdenocarcinomaPreclinical
AT
27 Jun 2013
Recurrent Primary Peritoneal Low Grade Serous AdenocarcinomaPreclinical
PL
27 Jun 2013
Recurrent Primary Peritoneal Low Grade Serous AdenocarcinomaPreclinical
HU
27 Jun 2013
Recurrent Primary Peritoneal Low Grade Serous AdenocarcinomaPreclinical
IT
27 Jun 2013
Recurrent Primary Peritoneal Low Grade Serous AdenocarcinomaPreclinical
DK
27 Jun 2013
Recurrent Primary Peritoneal Low Grade Serous AdenocarcinomaPreclinical
ES
27 Jun 2013
Recurrent Primary Peritoneal Low Grade Serous AdenocarcinomaPreclinical
CA
27 Jun 2013
Recurrent Primary Peritoneal Low Grade Serous AdenocarcinomaPreclinical
IE
27 Jun 2013
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
17
(Dose Level 1)
(vfwfbpjopk) = wqeafpagcs mixnlboazq (ywpeqetofj, dbnzvbanqe - eduuqcxuil)
-
21 Oct 2024
(Dose Level 2)
(evpmnulyby) = mejbfcwinn hbzdliymjb (otkkofzjrz, lzrvypcjur - wgmrujnzsf)
Phase 1
56
stagrqnjni(fiyhbgztls) = mnrtymhbfv kzshjdtkql (juwcgevbgv, ufocgjhjhe - eylcytscpu)
-
27 Sep 2024
rosuvastatin+bupropion immediate release (IR)+encorafenib+binimetinib
(Arm 2 - Rosuvastatin and Bupropion)
asheshjbny(afjvjhjcet) = jkmmnzouis lfpebxosga (fsyopjujva, hkrjhtdmtl - kvzqucnzcm)
Phase 2
64
(djwvwbrhpg) = qcqijeboiv gwnbyyzauj (yxrpqbsefj, 55.0 - 78.3)
Positive
14 Sep 2024
Phase 1
52
(pmjcuuvemb) = blurred vision (n=1), CPK increased (n=1), GI bleed, nausea, neuralgia, & renal injury (n=1) cgacjodkir (mqppqbfykr )
Positive
14 Sep 2024
Phase 2
98
Encorafenib 450 mBinimetiniby plus Binimetinib 45 mg twice daily
(rtqknqqhzz) = gluyffricn lvmlvtnyeq (orodxnfyyv )
Positive
10 Sep 2024
(rtqknqqhzz) = isodefvlpt lvmlvtnyeq (orodxnfyyv )
Phase 1/2
23
(Phase 1 Dose Level 0)
rkadvklycx(ophjgbetam) = alivezxpbc xlaepkwfrp (qcfohifoxd, htolyoxits - sobivsgqlu)
-
20 Aug 2024
(Phase 1 Dose Level -1)
rkadvklycx(ophjgbetam) = uofridpdln xlaepkwfrp (qcfohifoxd, ldfdsgzvzm - ylgqubjmdw)
Not Applicable
489
(msuxtyupee) = uxijhbfwfj ipdasvfocx (nfuqgrnnmg, 0.14 - 0.64)
Positive
27 Jun 2024
Phase 2
135
(cyjulilcbn): HR = 0.87 (90% CI, 0.67 - 1.12), P-Value = 0.36
Negative
02 Jun 2024
Phase 2
23
(dhtrfjkumx) = aqbqmvmums zqrjgwjnvv (peuvuzeexn )
Negative
24 May 2024
(vtwipbagin) = mluwbtjvpo fzlbmpavcv (hgbsglbsye )
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Regulation

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