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 |
|---|---|
| neoplasms | D009369 |
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 |
|---|---|---|---|---|
| COTELLIC | Genentech | N-206192 RX | 2015-11-10 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| cotellic | New Drug Application | 2020-10-30 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| melanoma | — | D008545 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
COBIMETINIB FUMARATE, COTELLIC, GENENTECH INC | |||
| 2029-10-28 | ODE-416 | ||
| 2026-01-28 | PED | ||
| 2025-10-28 | I-902 | ||
| 2025-07-28 | M-278 | ||
HCPCS
No data
Clinical
Clinical Trials
110 clinical trials
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Indications Phases 4
No data
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | 5 | — | — | — | 6 |
| Multiple myeloma | D009101 | C90.0 | 3 | 4 | — | — | — | 5 | |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 4 | 1 | — | — | — | 4 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 1 | 3 | — | — | — | 4 |
| Non-hodgkin lymphoma | D008228 | C85.9 | 1 | 2 | — | — | — | 3 | |
| Myelomonocytic leukemia chronic | D015477 | C93.1 | 1 | 1 | — | — | — | 2 | |
| Gastrointestinal neoplasms | D005770 | C26.9 | 1 | 2 | — | — | — | 2 | |
| Fallopian tube neoplasms | D005185 | 1 | 1 | — | — | — | 2 | ||
| Cholangiocarcinoma | D018281 | C22.1 | — | 2 | — | — | — | 2 | |
| Gallbladder neoplasms | D005706 | EFO_0004606 | C23 | — | 2 | — | — | — | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 7 | — | — | — | — | 7 | ||
| Myeloid leukemia acute | D015470 | C92.0 | 3 | — | — | — | — | 3 | |
| Myelodysplastic syndromes | D009190 | D46 | 1 | — | — | — | — | 1 | |
| Prostatic neoplasms | D011471 | C61 | 1 | — | — | — | — | 1 | |
| Castration-resistant prostatic neoplasms | D064129 | 1 | — | — | — | — | 1 | ||
| Primary myelofibrosis | D055728 | D47.4 | 1 | — | — | — | — | 1 | |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | C91.0 | 1 | — | — | — | — | 1 | |
| B-cell chronic lymphocytic leukemia | D015451 | C91.1 | 1 | — | — | — | — | 1 | |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | 1 | — | — | — | — | 1 | |
| Anemia | D000740 | EFO_0004272 | D64.9 | 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 | COBIMETINIB |
| INN | cobimetinib |
| 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 class | tyrosine 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
| PDB | 7M0V |
| CAS-ID | 934660-93-2 |
| RxCUI | 1722365 |
| ChEMBL ID | CHEMBL2146883 |
| ChEBI ID | — |
| PubChem CID | 16222096 |
| DrugBank | DB05239 |
| UNII ID | ER29L26N1X (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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