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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Commercial
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 |
|---|---|---|---|---|
| MEKTOVI | Array Biopharma | N-210498 RX | 2018-06-27 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| mektovi | New Drug Application | 2025-03-20 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
BINIMETINIB, MEKTOVI, ARRAY BIOPHARMA INC | |||
| 2025-06-27 | ODE-194 | ||
| 2023-06-27 | NCE | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Binimetinib, Mektovi, Array Biopharma Inc | |||
| 9562016 | 2033-10-18 | DS, DP | |
| 9598376 | 2033-10-18 | U-2330 | |
| 9980944 | 2033-10-18 | U-2334 | |
| 9314464 | 2031-07-04 | U-2332 | |
| 9850229 | 2030-08-27 | U-2333 | |
| 10005761 | 2030-08-27 | U-2331 | |
| 7777050 | 2024-03-13 | DS, DP | |
| 8178693 | 2023-03-13 | DS, DP | |
| 8193229 | 2023-03-13 | U-2330 | |
| 8513293 | 2023-03-13 | U-2331 | |
HCPCS
No data
Clinical
Clinical Trials
142 clinical trials
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colorectal neoplasms | D015179 | — | — | 9 | 9 | 1 | — | — | 17 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 4 | 8 | 1 | — | — | 11 |
| Cutaneous malignant melanoma | D000096142 | — | — | 1 | 4 | 2 | — | — | 6 |
| Biliary tract neoplasms | D001661 | — | C24.9 | 4 | 3 | 1 | — | — | 6 |
| Colonic neoplasms | D003110 | — | C18 | 2 | 2 | 1 | — | — | 5 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | — | 3 | 1 | — | — | 4 |
| Skin neoplasms | D012878 | EFO_0004198 | C44 | 1 | 2 | 1 | — | — | 4 |
| Fallopian tube neoplasms | D005185 | — | — | 1 | 1 | 1 | — | — | 3 |
| Ovarian epithelial carcinoma | D000077216 | — | — | 1 | — | 1 | — | — | 2 |
| Skin diseases | D012871 | — | L00-L99 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Non-small-cell lung carcinoma | D002289 | — | — | 15 | 8 | — | — | — | 19 |
| Lung neoplasms | D008175 | — | C34.90 | 7 | 9 | — | — | — | 14 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 4 | 7 | — | — | — | 9 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 2 | 8 | — | — | — | 9 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | 6 | — | — | — | 6 |
| Carcinoma | D002277 | — | C80.0 | 2 | 2 | — | — | — | 4 |
| Triple negative breast neoplasms | D064726 | — | — | 3 | 3 | — | — | — | 4 |
| Leukemia | D007938 | — | C95 | 3 | 2 | — | — | — | 4 |
| Adenocarcinoma | D000230 | — | — | 3 | 3 | — | — | — | 4 |
| Glioma | D005910 | EFO_0000520 | — | 1 | 3 | — | — | — | 4 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | 2 | — | — | — | — | 2 |
| Hepatic insufficiency | D048550 | — | — | 2 | — | — | — | — | 2 |
| Hereditary sensory and autonomic neuropathies | D009477 | — | — | 1 | — | — | — | — | 1 |
| Central nervous system neoplasms | D016543 | — | — | 1 | — | — | — | — | 1 |
| Brain diseases | D001927 | — | G93.40 | 1 | — | — | — | — | 1 |
| Disease progression | D018450 | — | — | 1 | — | — | — | — | 1 |
| Gene rearrangement | D015321 | — | — | 1 | — | — | — | — | 1 |
| Small cell carcinoma | D018288 | — | — | 1 | — | — | — | — | 1 |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | 1 | — | — | — | — | 1 |
| Recurrence | D012008 | — | — | 1 | — | — | — | — | 1 |
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Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Binimetinib |
| INN | binimetinib |
| 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 class | tyrosine kinase inhibitors: tyrosine kinase inhibitors; MEK (MAPK kinase) inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Cn1cnc2c(F)c(Nc3ccc(Br)cc3F)c(C(=O)NOCCO)cc21 |
Identifiers
| PDB | — |
| CAS-ID | 606143-89-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL3187723 |
| ChEBI ID | — |
| PubChem CID | 10288191 |
| DrugBank | DB11967 |
| UNII ID | 181R97MR71 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
BRAF
BRAF
Organism
Homo sapiens
Gene name
BRAF
Gene synonyms
BRAF1, RAFB1
NCBI Gene ID
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
Mouse ortholog
Braf (109880)
serine/threonine-protein kinase B-raf (P28028)
Variants
No data
Financial
Revenue by drug
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Mektovi – Pfizer
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Mektovi – Array Biopharma
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Tabular view
Estimated US medical usage
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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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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