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AboutPricing
Drug ReportsBinimetinib
Mektovi(binimetinib)
Mektovi (binimetinib) is a small molecule pharmaceutical. Binimetinib was first approved as Mektovi on 2018-06-27. It is used to treat melanoma in the USA. It has been approved in Europe to treat melanoma. The pharmaceutical is active against dual specificity mitogen-activated protein kinase kinase 2 and dual specificity mitogen-activated protein kinase kinase 1.
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Events Timeline
5D
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3M
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YTD
1Y
2Y
5Y
Max
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
Trade Name
FDA
EMA
Mektovi
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Binimetinib
Tradename
Company
Number
Date
Products
MEKTOVIArray BiopharmaN-210498 RX2018-06-27
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
mektoviNew Drug Application2025-03-20
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
melanoma—D008545—
Agency Specific
FDA
EMA
Expiration
Code
BINIMETINIB, MEKTOVI, ARRAY BIOPHARMA INC
2025-06-27ODE-194
2023-06-27NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Binimetinib, Mektovi, Array Biopharma Inc
95620162033-10-18DS, DP
95983762033-10-18U-2330
99809442033-10-18U-2334
93144642031-07-04U-2332
98502292030-08-27U-2333
100057612030-08-27U-2331
77770502024-03-13DS, DP
81786932023-03-13DS, DP
81932292023-03-13U-2330
85132932023-03-13U-2331
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
— L01EE: Mitogen-activated protein kinase (mek) inhibitors
— L01EE03: Binimetinib
HCPCS
No data
Clinical
Clinical Trials
143 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Lung neoplasmsD008175—C34.9041———4
Non-small-cell lung carcinomaD002289——31———3
MelanomaD008545———3———3
NeoplasmsD009369—C8031———3
LeukemiaD007938—C9521———2
Myeloid leukemiaD007951—C9221———2
CarcinomaD002277—C80.0—1———1
Breast neoplasmsD001943EFO_0003869C50—1———1
Triple negative breast neoplasmsD064726———1———1
Invasive hydatidiform moleD002820—D39.2—1———1
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Colorectal neoplasmsD015179——2————2
Colonic neoplasmsD003110—C181————1
Rectal neoplasmsD012004——1————1
Gastrointestinal stromal tumorsD046152EFO_0000505C49.A1————1
Disease progressionD018450——1————1
Gene rearrangementD015321——1————1
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_0000340—1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameBinimetinib
INNbinimetinib
Description
Binimetinib is a member of the class of benzimidazoles that is 1-methyl-1H-benzimidazole which is substituted at positions 4, 5, and 6 by fluorine, (4-bromo-2-fluorophenyl)nitrilo, and N-(2-hydroxyethoxy)aminocarbonyl groups, respectively. It is a MEK1 and MEK2 inhibitor (IC50= 12 nM). Approved by the FDA for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation in combination with encorafenib. It has a role as an EC 2.7.11.24 (mitogen-activated protein kinase) inhibitor, an antineoplastic agent and an apoptosis inducer. It is a member of benzimidazoles, a member of bromobenzenes, a member of monofluorobenzenes, a hydroxamic acid ester and a secondary amino compound.
Classification
Small molecule
Drug classtyrosine kinase inhibitors: tyrosine kinase inhibitors; MEK (MAPK kinase) inhibitors
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
Cn1cnc2c(F)c(Nc3ccc(Br)cc3F)c(C(=O)NOCCO)cc21
Identifiers
PDB—
CAS-ID606143-89-9
RxCUI—
ChEMBL IDCHEMBL3187723
ChEBI ID—
PubChem CID10288191
DrugBankDB11967
UNII ID181R97MR71 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
BRAF
BRAF
Organism
Homo sapiens
Gene name
BRAF
Gene synonyms
BRAF1, RAFB1
NCBI Gene ID
673
Protein name
serine/threonine-protein kinase B-raf
Protein synonyms
94 kDa B-raf protein, B-Raf proto-oncogene serine/threonine-protein kinase (p94), B-Raf serine/threonine-protein, murine sarcoma viral (v-raf) oncogene homolog B1, p94, Proto-oncogene B-Raf, v-raf murine sarcoma viral oncogene homolog B, v-Raf murine sarcoma viral oncogene homolog B1
Uniprot ID
Q9Y6T3
Mouse ortholog
Braf (109880)
serine/threonine-protein kinase B-raf (P28028)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Mektovi – Pfizer
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Mektovi – Array Biopharma
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,766 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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7,329 adverse events reported
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