Mekinist(trametinib)
Mekinist, Trametinib Dimethyl Sulfoxide (trametinib) is a small molecule pharmaceutical. Trametinib was first approved as Mekinist on 2013-05-29. It is used to treat melanoma and non-small-cell lung carcinoma in the USA. It has been approved in Europe to treat melanoma. The pharmaceutical is active against dual specificity mitogen-activated protein kinase kinase 1 and dual specificity mitogen-activated protein kinase kinase 2.
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FDA approval date
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| respiratory tract diseases | D012140 |
Trade Name
FDA
EMA
Mekinist (discontinued: Mekinist, Trametinib dimethyl sulfoxide)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| mekinist | New Drug Application | 2025-08-12 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| non-small-cell lung carcinoma | — | D002289 | — |
| melanoma | — | D008545 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
TRAMETINIB DIMETHYL SULFOXIDE, MEKINIST, NOVARTIS | |||
| 2030-03-16 | ODE-428 | ||
| 2026-03-16 | I-908, NP | ||
| 2025-12-22 | PED | ||
| 2025-11-04 | PED | ||
| 2025-10-30 | PED | ||
| 2025-06-22 | I-895 | ||
| 2025-05-04 | ODE-183 | ||
| 2025-04-30 | ODE-182 | ||
| 2024-12-22 | PED | ||
| 2024-06-22 | ODE-148 | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Trametinib Dimethyl Sulfoxide, Mekinist, Novartis | |||
| 10869869 | 2033-08-30 | U-3184 | |
| 8580304 | 2032-01-28 | DP | |
| 9155706 | 2032-01-28 | DP | |
| 9271941 | 2032-01-28 | DP | |
| 9399021 | 2032-01-28 | DP | |
| 8703781 | 2030-10-15 | DS, DP | U-1712, U-2020, U-2037, U-2302, U-2305, U-3564 |
| 8952018 | 2030-10-15 | U-2020 | |
| 7378423 | 2027-05-29 | DS, DP | |
| 8835443 | 2025-06-10 | U-1581, U-1582, U-2020, U-2037, U-2302, U-2305, U-3564 | |
HCPCS
No data
Clinical
Clinical Trials
293 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Melanoma | D008545 | — | — | 33 | 50 | 9 | 1 | 23 | 101 |
| Neoplasms | D009369 | — | C80 | 48 | 39 | 1 | 1 | 3 | 83 |
| Non-small-cell lung carcinoma | D002289 | — | — | 18 | 13 | — | 1 | 4 | 30 |
| Thyroid neoplasms | D013964 | EFO_0003841 | — | 3 | 15 | 2 | 2 | — | 21 |
| Lung neoplasms | D008175 | — | C34.90 | 11 | 12 | — | 1 | 2 | 21 |
| Thyroid diseases | D013959 | — | E00-E07 | 2 | 12 | 2 | 2 | — | 18 |
| Glioma | D005910 | EFO_0000520 | — | 4 | 8 | — | 1 | 1 | 12 |
| Astrocytoma | D001254 | EFO_0000271 | — | 1 | 3 | — | 1 | 1 | 6 |
| Neurofibromatosis 1 | D009456 | — | Q85.01 | 2 | 4 | — | 1 | — | 5 |
| Glioblastoma | D005909 | EFO_0000515 | — | 1 | 2 | — | 1 | 1 | 5 |
Show 10 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Recurrence | D012008 | — | — | 6 | 4 | 1 | — | 3 | 11 |
| Adenocarcinoma | D000230 | — | — | 6 | 3 | 1 | — | — | 8 |
| Skin neoplasms | D012878 | EFO_0004198 | C44 | 2 | 5 | 1 | — | 1 | 8 |
| Adamantinoma | D050398 | — | — | — | 4 | 1 | — | — | 4 |
| Ameloblastoma | D000564 | — | — | — | 3 | 1 | — | — | 3 |
| Sarcoma | D012509 | — | — | 1 | — | 1 | — | — | 2 |
| Fever | D005334 | — | R50.9 | — | 1 | 1 | — | — | 2 |
| Hyperthermia | D000084462 | — | — | — | 1 | 1 | — | — | 2 |
| Serous cystadenocarcinoma | D018284 | — | — | 1 | 1 | 1 | — | — | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colorectal neoplasms | D015179 | — | — | 12 | 12 | — | — | — | 19 |
| Carcinoma | D002277 | — | C80.0 | 6 | 7 | — | — | 1 | 13 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 6 | 8 | — | — | — | 12 |
| Multiple myeloma | D009101 | — | C90.0 | 4 | 8 | — | — | — | 11 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 5 | 5 | — | — | — | 10 |
| Cutaneous malignant melanoma | D000096142 | — | — | 3 | 7 | — | — | 1 | 10 |
| Hematologic neoplasms | D019337 | — | — | 3 | 8 | — | — | — | 9 |
| Leukemia | D007938 | — | C95 | 3 | 4 | — | — | 1 | 7 |
| Lymphoma | D008223 | — | C85.9 | 2 | 6 | — | — | — | 7 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 2 | 5 | — | — | — | 7 |
Show 69 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cancer pain | D000072716 | — | G89.3 | 2 | — | — | — | — | 2 |
| Oncogenes | D009857 | — | — | 2 | — | — | — | — | 2 |
| Meningioma | D008579 | EFO_0003098 | D32.9 | 2 | — | — | — | — | 2 |
| Castration-resistant prostatic neoplasms | D064129 | — | — | 1 | — | — | — | — | 1 |
| Myeloproliferative disorders | D009196 | — | D47.1 | 1 | — | — | — | — | 1 |
| Primary myelofibrosis | D055728 | — | D47.4 | 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 |
| Hodgkin disease | D006689 | — | C81 | 1 | — | — | — | — | 1 |
Show 29 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Acute disease | D000208 | — | — | — | — | — | — | 1 | 1 |
| Small cell lung carcinoma | D055752 | — | — | — | — | — | — | 1 | 1 |
| Erectile dysfunction | D007172 | EFO_0004234 | F52.21 | — | — | — | — | 1 | 1 |
| Eunuchism | D005058 | EFO_0007266 | E29.1 | — | — | — | — | 1 | 1 |
| Physiological sexual dysfunction | D012735 | — | — | — | — | — | — | 1 | 1 |
| Fertility | D005298 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Trametinib |
| INN | trametinib |
| Description | Trametinib is a pyridopyrimidine that is used (as its dimethyl sulfoxide addition compound) for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations, and who have not received prior BRAF inhibitor treatment. It has a role as an EC 2.7.11.24 (mitogen-activated protein kinase) inhibitor, an antineoplastic agent, an anticoronaviral agent and a geroprotector. It is a pyridopyrimidine, an organofluorine compound, an organoiodine compound, a member of acetamides, a ring assembly, a member of cyclopropanes and an aromatic amine. |
| 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) | CC(=O)Nc1cccc(-n2c(=O)n(C3CC3)c(=O)c3c(Nc4ccc(I)cc4F)n(C)c(=O)c(C)c32)c1 |
Identifiers
| PDB | — |
| CAS-ID | 871700-17-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2103875 |
| ChEBI ID | 75998 |
| PubChem CID | 11707110 |
| DrugBank | DB08911 |
| UNII ID | 33E86K87QN (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
No data
Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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22,839 adverse events reported
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