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Cotellic(cobimetinib)
Cotellic (cobimetinib) is a small molecule pharmaceutical. Cobimetinib was first approved as Cotellic on 2015-11-10. 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. In addition, it is known to target dual specificity mitogen-activated protein kinase kinase 7 and serine/threonine-protein kinase B-raf.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
Trade Name
FDA
EMA
Cotellic
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Cobimetinib fumarate
Tradename
Company
Number
Date
Products
COTELLICGenentechN-206192 RX2015-11-10
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
cotellicNew Drug Application2020-10-30
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
melanomaD008545
Agency Specific
FDA
EMA
Expiration
Code
COBIMETINIB FUMARATE, COTELLIC, GENENTECH INC
2029-10-28ODE-416
2026-01-28PED
2025-10-28I-902
2025-07-28M-278
Patent Expiration
Patent
Expires
Flag
FDA Information
Cobimetinib Fumarate, Cotellic, Genentech Inc
105901022036-06-30DS, DPU-1776
112546492036-06-30DS, DPU-1776
104784002036-06-29DS, DPU-1776
110873542034-06-22U-1776
78038392029-11-10DS, DP
83620022026-10-05U-1776
115976992026-10-05U-3554
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
L01EE02: Cobimetinib
HCPCS
No data
Clinical
Clinical Trials
110 clinical trials
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Mock data
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MelanomaD00854510173331
NeoplasmsD009369C8011161125
Non-small-cell lung carcinomaD0022893617
Colorectal neoplasmsD0151791315
Hematologic neoplasmsD0193371112
DiseaseD004194EFO_0000408R6911
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C50256
Multiple myelomaD009101C90.0345
Pancreatic neoplasmsD010190EFO_0003860C25414
Ovarian neoplasmsD010051EFO_0003893C56134
Non-hodgkin lymphomaD008228C85.9123
Myelomonocytic leukemia chronicD015477C93.1112
Gastrointestinal neoplasmsD005770C26.9122
Fallopian tube neoplasmsD005185112
CholangiocarcinomaD018281C22.122
Gallbladder neoplasmsD005706EFO_0004606C2322
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients77
Myeloid leukemia acuteD015470C92.033
Myelodysplastic syndromesD009190D4611
Prostatic neoplasmsD011471C6111
Castration-resistant prostatic neoplasmsD06412911
Primary myelofibrosisD055728D47.411
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.011
B-cell chronic lymphocytic leukemiaD015451C91.111
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_000034011
AnemiaD000740EFO_0004272D64.911
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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 nameCOBIMETINIB
INNcobimetinib
Description
Cobimetinib is a member of the class of N-acylazetidines obtained by selective formal condensation of the carboxy group of 3,4-difluoro-2-(2-fluoro-4-iodoanilino)benzoic acid with the secondary amino group from the azetidine ring of 3-[(2S)-piperidin-2-yl]azetidin-3-ol. An inhibitor of mitogen-activated protein kinase that is used (as its fumarate salt) in combination with vemurafenib for the treatment of patients with unresectable or metastatic melanoma. It has a role as an EC 2.7.11.24 (mitogen-activated protein kinase) inhibitor and an antineoplastic agent. It is a member of piperidines, a N-acylazetidine, a tertiary alcohol, an aromatic amine, a secondary amino compound, a difluorobenzene and an organoiodine compound. It is a conjugate base of a cobimetinib(1+).
Classification
Small molecule
Drug classtyrosine kinase inhibitors: tyrosine kinase inhibitors; MEK (MAPK kinase) inhibitors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
O=C(c1ccc(F)c(F)c1Nc1ccc(I)cc1F)N1CC(O)([C@@H]2CCCCN2)C1
Identifiers
PDB7M0V
CAS-ID934660-93-2
RxCUI1722365
ChEMBL IDCHEMBL2146883
ChEBI ID
PubChem CID16222096
DrugBankDB05239
UNII IDER29L26N1X (ChemIDplus, GSRS)
Target
Agency Approved
MAP2K2
MAP2K2
MAP2K1
MAP2K1
Organism
Homo sapiens
Gene name
MAP2K2
Gene synonyms
MEK2, MKK2, PRKMK2
NCBI Gene ID
Protein name
dual specificity mitogen-activated protein kinase kinase 2
Protein synonyms
ERK activator kinase 2, MAP kinase kinase 2, MAPK/ERK kinase 2, MEK 2, mitogen-activated protein kinase kinase 2, p45
Uniprot ID
Mouse ortholog
Map2k2 (26396)
dual specificity mitogen-activated protein kinase kinase 2 (Q9D7B0)
Alternate
MAP2K7
MAP2K7
BRAF
BRAF
Organism
Homo sapiens
Gene name
MAP2K7
Gene synonyms
JNKK2, MEK7, MKK7, PRKMK7, SKK4
NCBI Gene ID
Protein name
dual specificity mitogen-activated protein kinase kinase 7
Protein synonyms
c-Jun N-terminal kinase kinase 2, JNK kinase 2, JNK-activating kinase 2, JNKK 2, MAP kinase kinase 7, MAPK/ERK kinase 7, MEK 7, SAPK kinase 4, SAPKK-4, SAPKK4, Stress-activated protein kinase kinase 4
Uniprot ID
Mouse ortholog
Map2k7 (26400)
dual specificity mitogen-activated protein kinase kinase 7 (Q8CE90)
Variants
Clinical Variant
No data
Financial
Cotellic - Exelixis
$
£
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Cotellic - Roche
$
£
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,770 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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11,650 adverse events reported
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