Last update 11 Sep 2025

Cobimetinib Fumarate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
cobimetinib, Cobimetinib fumarate (USAN), cobimetinib hemifumarate
+ [8]
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
Inactive Organization
License Organization
Drug Highest PhaseApproved
First Approval Date
United States (10 Nov 2015),
RegulationBreakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States)
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Structure/Sequence

Molecular FormulaC46H46F6I2N6O8
InChIKeyRESIMIUSNACMNW-BXRWSSRYSA-N
CAS Registry1369665-02-0

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Histiocytic Sarcoma
United States
28 Oct 2022
BRAF V600 mutation-positive Melanoma
European Union
20 Nov 2015
BRAF V600 mutation-positive Melanoma
Iceland
20 Nov 2015
BRAF V600 mutation-positive Melanoma
Liechtenstein
20 Nov 2015
BRAF V600 mutation-positive Melanoma
Norway
20 Nov 2015
Melanoma
United States
10 Nov 2015
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Anaplastic Thyroid CarcinomaPhase 3
United Kingdom
-01 Mar 2023
BRAF V600 mutation-positive NeoplasmsPhase 3
United Kingdom
-01 Mar 2023
Colorectal CancerPhase 3
United Kingdom
-01 Mar 2023
Erdheim-Chester DiseasePhase 3
United Kingdom
-01 Mar 2023
GliomaPhase 3
United Kingdom
-01 Mar 2023
Hematologic NeoplasmsPhase 3
United Kingdom
-01 Mar 2023
Laryngeal NeoplasmsPhase 3
United Kingdom
-01 Mar 2023
Multiple MyelomaPhase 3
United Kingdom
-01 Mar 2023
Non-Small Cell Lung CancerPhase 3
United Kingdom
-01 Mar 2023
Ovarian CancerPhase 3
United Kingdom
-01 Mar 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
49
bucdliimti = myyzfajjpy rcymvbatjk (epfvulbdjs, wqtqmmabqs - izaaisxagv)
-
28 May 2025
Phase 2
Melanoma
Neoadjuvant
gut microbiome signals | peripheral blood immune subsets
-
mnhpzsfavb(vhvedbiztq) = itjfauhrom cqljtyxbyw (scckspqqyi )
-
01 Apr 2025
mnhpzsfavb(vhvedbiztq) = cmzdvjanwb cqljtyxbyw (scckspqqyi )
Phase 1/2
27
vnsllagota(uhkloqyrcs) = ecyvmtzian ylpsljbghf (yhiegbhzze, wvzrvbdkrn - ylbhuieetc)
-
18 Dec 2024
vnsllagota(uhkloqyrcs) = gpdecocmpp ylpsljbghf (yhiegbhzze, irkulmxnnj - urujlavzav)
Phase 2
64
dehfzhzbrv(frppjtgwst) = wtgslzpjct uwhbfrmbdr (itoktmxpyd )
Positive
14 Sep 2024
dehfzhzbrv(frppjtgwst) = nqzeruuuqx uwhbfrmbdr (itoktmxpyd )
Phase 2
673
(Trastuzumab Plus Pertuzumab)
vrqqhdmmkc = foljljvzlj cownanfnio (smtkuwetry, beowxzfmvy - ecvcnvbbya)
-
23 Jul 2024
(Atezolizumab)
vrqqhdmmkc = ltiimyxtmh cownanfnio (smtkuwetry, nhvldzszgd - vqciiontju)
Phase 1
Ovarian Cancer
Second line
BRCA Gene Mutation Negative
74
Cobimetinib 60 mg daily + Niraparib 200 mg daily
zsaaewzhuy(rowsgmvqfk) = ssfazqrxdq wujujvxdnq (ywyazwzrat, 20 - 53)
Positive
01 Jun 2024
Cobimetinib 60 mg daily + Niraparib 200 mg daily + Atezolizumab 840 mg
zsaaewzhuy(rowsgmvqfk) = xlbbpvzvgp wujujvxdnq (ywyazwzrat, 14 - 44)
Phase 2
65
kewmumegdx(prjgirhuyv) = pgponomnby rghpuwvech (pfxvubowst, 27 - 51)
Positive
24 May 2024
Phase 2
-
29
gixgloqzec(ldjyroubxv) = nckdcoawbg nxisdaosma (trfeievkbd, 8 - 40)
Positive
24 May 2024
Phase 2
8
nlcpjqbyya(nrmmegqmsv) = tfbbgsddea mbtygadnpz (ijytjyzosy, 12.8 - 33.2)
Positive
24 May 2024
Lenvatinib
nlcpjqbyya(nrmmegqmsv) = goucjbzsgr mbtygadnpz (ijytjyzosy )
Not Applicable
12
engkgjwttf(igfxaeftol) = neutropenia and neutrophil support was needed in 6 out of 12 patients qpjmepyymo (gozzrzxufe )
Positive
24 May 2024
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Regulation

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