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Drug ReportsTrametinib
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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Novartis Pharmaceuticals
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Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
respiratory tract diseasesD012140
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)
Trametinib dimethyl sulfoxide
Tradename
Company
Number
Date
Products
MEKINISTNovartisN-204114 RX2013-05-29
2 products, RLD, RS
MEKINISTNovartisN-217513 RX2023-03-16
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
mekinistNew Drug Application2024-10-01
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
2030-03-16ODE-428
2026-03-16I-908, NP
2025-12-22PED
2025-11-04PED
2025-10-30PED
2025-06-22I-895
2025-05-04ODE-183
2025-04-30ODE-182
2024-12-22PED
2024-06-22ODE-148
Patent Expiration
Patent
Expires
Flag
FDA Information
Trametinib Dimethyl Sulfoxide, Mekinist, Novartis
108698692033-08-30U-3184
85803042032-01-28DP
91557062032-01-28DP
92719412032-01-28DP
93990212032-01-28DP
87037812030-10-15DS, DPU-1712, U-2020, U-2037, U-2302, U-2305, U-3564
89520182030-10-15U-2020
73784232027-05-29DS, DP
88354432025-06-10U-1581, U-1582, U-2020, U-2037, U-2302, U-2305, U-3564
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
— L01EE01: Trametinib
HCPCS
No data
Clinical
Clinical Trials
279 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MelanomaD008545——33539122102
NeoplasmsD009369—C804840—1381
Non-small-cell lung carcinomaD002289——1714—1429
Lung neoplasmsD008175HP_0100526C34.901314—1224
Thyroid neoplasmsD013964EFO_0003841—41521—21
Thyroid diseasesD013959HP_0000820E00-E0731421—20
GliomaD005910EFO_0000520—36—1110
NeurofibromatosesD017253—Q85.0036—1—7
AstrocytomaD001254EFO_0000271—13—116
Neurofibromatosis 1D009456—Q85.0124—1—5
Show 8 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
RecurrenceD012008——671—314
Cutaneous malignant melanomaD000096142——482—113
Skin neoplasmsD012878EFO_0004198C44481——11
AdenocarcinomaD000230——641——9
SarcomaD012509——2—1——3
FeverD005334HP_0001945R50.9—11——2
HyperthermiaD000084462———11——2
Serous cystadenocarcinomaD018284——111——2
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CarcinomaD002277—C80.0811——118
Colorectal neoplasmsD015179——1211———18
Multiple myelomaD009101—C90.048———11
Neoplasm metastasisD009362EFO_0009708—67———11
LeukemiaD007938—C9546——19
Hematologic neoplasmsD019337——38———9
Pancreatic neoplasmsD010190EFO_0003860C2545———9
LymphomaD008223—C85.926———7
Plasma cell neoplasmsD054219——44———7
Anaplastic thyroid carcinomaD065646——25———7
Show 74 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeuroblastomaD009447EFO_0000621—1———12
Cancer painD000072716—G89.32————2
OncogenesD009857——2————2
MeningiomaD008579EFO_0003098D32.92————2
Castration-resistant prostatic neoplasmsD064129——1————1
Myeloproliferative disordersD009196—D47.11————1
Primary myelofibrosisD055728—D47.41————1
B-cell chronic lymphocytic leukemiaD015451—C91.11————1
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_0000340—1————1
AnemiaD000740HP_0001903D64.91————1
Show 30 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Acute diseaseD000208——————11
Small cell lung carcinomaD055752——————11
Erectile dysfunctionD007172EFO_0004234F52.21————11
EunuchismD005058EFO_0007266E29.1————11
HypogonadismD007006HP_0000044E23.0————11
Physiological sexual dysfunctionD012735——————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTrametinib
INNtrametinib
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 classtyrosine kinase inhibitors: tyrosine kinase inhibitors; MEK (MAPK kinase) inhibitors
Image (chem structure or protein)Loading
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-ID871700-17-3
RxCUI—
ChEMBL IDCHEMBL2103875
ChEBI ID75998
PubChem CID11707110
DrugBankDB08911
UNII ID33E86K87QN (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
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 15,850 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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20,364 adverse events reported
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