Drug · Small Molecule

Trametinib

CI-DRUG-00000602Explore in graph →NCIt C77908 CHEMBL2103875 CIViC Approved

Regulatory

Approvals (33)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

health-canada-dpdRegulatory33 approval records from 3 sources (hover a row badge for its dataset) · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
CA Health Canada	—	Marketed in Canada as MEKINIST (DIN 02539993) under ATC L01EE01 TRAMETINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Nov 30, 2023	health-canada-dpd
CA

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 19 hours agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	67	24	13	214	33	CA, EU, US	May 29, 2013	Jul 28, 2008
Malignant Thyroid Gland Neoplasm	Approved	Phase 3	10	3	2	16	2	US	May 29, 2013	2011-10
Malignant Lung Neoplasm	Approved	Phase 4	8	2	1	26	2	US	May 29, 2013	2011-09
Malignant Central Nervous System Neoplasm	Phase4	Phase 4	2	0	0

Curated evidence

Clinical evidence (162)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 101–150 of 162 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
BRAF V6002
Trametinib	Melanoma

Clinical trials

Trials with this intervention (224)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–50 of 224 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT02015117	Trametinib With or Without Whole Brain Radiation Therapy in Treating Patients With Brain Metastases	active not recruiting	Phase 1	10	National Cancer Institute (NCI)NIH	1	Sep 25, 2026	clinicaltrials
NCT06475989	Study of Targeted Therapy vs. Chemotherapy in Patients With Thyroid Cancer	recruiting	Phase 3

Molecule

Record

Kind: Small Molecule
Mechanism: Dual specificity mitogen-activated protein kinase kinase 2 inhibitor; Dual specificity mitogen-activated protein kinase kinase 1 inhibitor; Dual specificity mitogen-activated protein kinase kinase; MEK1/2 inhibitor
Targets: 2 genes
UNII: BSB9VJ5TUT
Aliases: CPD 8B, GSK 1120212, GSK-1120212, GSK1120212, GSK1120212B, GSK-1120212TRAMETINIBMEKINISTA-1083G1357N-(3-{3-CYCLOPROPYL-5-[(2-FLUORO-4-IODOPHENYL)AMINO]-6,8-DIMETHYL-2,4,7-TRIOXO-3,4,6,7-TETRAHYDROPYRIDO[4,3-D]PYRIMIDIN-1(2H)-YL}PHENYL)ACETAMIDE GENERAL, GSK 212, GSK212, JTP 74057, JTP74057, MEK Inhibitor GSK1120212, Mekinist, N-(3-{3-cyclopropyl-5-[(2-fluoro-4-iodophenyl)amino]-6,8-dimethyl-2,4,7-trioxo-3,4,6,7-tetrahydropyrido[4,3-d]pyrimidin-1(2H)-yl}phenyl)acetamide, Spexotras, Tmt212, TMT-212, TMT212, Trametinib, TRAMETINIB DIMETHYL SULFOXIDE, TRAMETINIB (GSK1120212)

Data updated 22 hours agoSource updated unknown

Identifiers

Codes (11)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01EE01	TRAMETINIB

BRAF V600E21
Dabrafenib + TrametinibCombination	Melanoma	Predictive	B	Supports Sensitivity Response	5	accepted	EID95 Dabrafenib with trametinib provides higher response rate and lower toxicity (as compared to chemotherapy) in patients with melanoma. PMID 24583796 · Menzies et al., 2014 · Open in CIViC	civic
〃	Melanoma	Predictive	B	Supports Sensitivity Response	5	accepted	EID6178 Adjuvant dual treatment with BRAF inhibitor dabrafenib and MEK inhibitor trametinib was administered to patients with stage III resected melenoma with V600E or V600K mutation in this stage III trial (… (full text at CIViC) PMID 28891408 · Long et al., 2017 · Open in CIViC	civic
〃	Melanoma	Predictive	B	Supports Sensitivity Response	5	accepted	EID6938 In this Phase III trial (NCT01584648 COMBI-d), previously untreated patients with unresectable stage IIIC or IV melanoma with BRAF V600E (359 patients) or V600K (61 patients) received dabrafenib and t… (full text at CIViC) PMID 25265492 · Long et al., 2014 · Open in CIViC	civic
〃	Melanoma	Predictive	B	Supports Sensitivity Response	4	accepted	EID6940 In this Phase I and II study (NCT01072175) patients with metastatic melanoma were given dabrafenib and trametinib combination therapy vs. dabrafenib monotherapy. From V600E patients, 45 received monot… (full text at CIViC) PMID 23020132 · Flaherty et al., 2012 · Open in CIViC	civic
Trametinib	Melanoma	Predictive	B	Supports Sensitivity Response	4	accepted	EID2135 In a study of 322 advanced melanoma patients with BRAF-V600E (N=281), BRAF-V600K (N=40), or both mutations (N=1), treatment with trametinib was associated with improved progression-free survival (4.8m… (full text at CIViC) PMID 22663011 · Flaherty et al., 2012 · Open in CIViC	civic
〃	Melanoma	Predictive	D	Supports Sensitivity Response	—	submitted	EID2131 An inducible BRAF-V600E mouse melanoma model shows a tight correlation between activated BRAF and disease progression. PMID 16424035 · Hoeflich et al., 2006 · Open in CIViC	civic
〃	Melanoma	Predictive	D	Supports Sensitivity Response	—	submitted	EID2134 An inducible BRAF-V600E mouse melanoma model shows a tight correlation between activated BRAF and disease progression. PMID 16424035 · Hoeflich et al., 2006 · Open in CIViC	civic
Mirdametinib + TrametinibSubstitutes	Melanoma	Predictive	D	Does Not Support Resistance	3	accepted	EID86 In the setting of BRAF(V600E), NF1 loss resulted in elevated activation of RAS-GTP but does not show resistance to MEK inhibitors. PMID 24576830 · Nissan et al., 2014 · Open in CIViC	civic
Dabrafenib + TrametinibCombination	Pilocytic Astrocytoma	Predictive	A	Supports Sensitivity Response	1	submitted	EID11313 This study is part of an ongoing open-label, single-arm, phase 2 Rare Oncology Agnostic Research (ROAR) basket trial enlisting 45 patients (31 with glioblastoma) into the high-grade glioma cohort (oth… (full text at CIViC) PMID 34838156 · Wen et al., 2022 · Open in CIViC	civic
〃	Pleomorphic Xanthoastrocytoma	Predictive	A	Supports Sensitivity Response	1	submitted	EID11312 This study is part of an ongoing open-label, single-arm, phase 2 Rare Oncology Agnostic Research (ROAR) basket trial enlisting 45 patients (31 with glioblastoma) into the high-grade glioma cohort (oth… (full text at CIViC) PMID 34838156 · Wen et al., 2022 · Open in CIViC	civic
〃	Pleomorphic Xanthoastrocytoma	Predictive	C	Supports Sensitivity Response	2	submitted	EID11311 In this case series, two patients with BRAF V600E mutant pleomorphic xanthoastrocytoma were treated using the BRAF inhibitor dabrafenib and trametinib in combination with the MEK inhibitor trametinib.… (full text at CIViC) PMID 28984141 · Brown et al., 2017 · Open in CIViC	civic
〃	Solid NeoplasmCURATED_BROADER	Predictive	A	Supports Sensitivity Response	4	accepted	EID12161 In this trial, patients with advanced rare tumours harbouring BRAF V600E mutations were treated with a combination of dabrafenib and trametinib. The study included eight distinct cohorts: anaplastic t… (full text at CIViC) PMID 37059834 · Subbiah et al., 2023 · Open in CIViC	civic
〃	Thyroid Gland Anaplastic CarcinomaALIAS	Predictive	B	Supports Sensitivity Response	4	accepted	EID6975 Interim analysis of a basket trial evaluating the combination of dabrafenib (BRAF inhibitor) and trametinib (MEK inhibitor) in previously treated V600E-mutated patients showed 11/16 patients with anap… (full text at CIViC) PMID 29072975 · Subbiah et al., 2018 · Open in CIViC	civic
〃	Thyroid Gland Anaplastic CarcinomaALIAS	Predictive	B	Supports Sensitivity Response	3	submitted	EID12957 In this retrospective, single-center, real-world study conducted between May 2018 and April 2022, 27 patients with anaplastic thyroid carcinoma (ATC) were stratified into three groups: patients with B… (full text at CIViC) PMID 36651156 · da Silva et al., 2023 · Open in CIViC	civic
〃	Thyroid Gland Anaplastic CarcinomaALIAS	Predictive	B	Supports Sensitivity Response	3	submitted	EID12959 This multi-institutional retrospective study analyzed 44 patients with anaplastic thyroid carcinoma (ATC) treated across three hospitals in Taiwan. BRAF mutation testing was performed in 24 patients (… (full text at CIViC) PMID 36504909 · Chang et al., 2022 · Open in CIViC	civic
〃	Thyroid Gland Anaplastic CarcinomaALIAS	Predictive	B	Supports Sensitivity Response	4	submitted	EID12960 In this systematic review and meta-analysis, the authors evaluated the predictive relevance of the BRAF V600E variant in patients with anaplastic thyroid carcinoma (ATC) treated with MAPK pathway-targ… (full text at CIViC) PMID 38709445 · Priantti et al., 2024 · Open in CIViC	civic
〃	Thyroid Gland Anaplastic CarcinomaALIAS	Predictive	B	Supports Sensitivity Response	3	submitted	EID13282 In a single-center retrospective study of 6 patients with BRAF V600E-positive anaplastic thyroid carcinoma treated with dabrafenib plus trametinib, 4/6 patients (67%; 95% CI 24–94%) achieved an object… (full text at CIViC) PMID 40844731 · Ando et al., 2025 · Open in CIViC	civic
〃	Thyroid Gland Anaplastic CarcinomaALIAS	Predictive	C	Supports Sensitivity Response	3	submitted	EID12956 A 47-year-old woman with advanced metastatic anaplastic thyroid carcinoma (ATC) harboring a BRAF V600E mutation, identified by comprehensive genomic profiling of a resected lung metastasis, received c… (full text at CIViC) PMID 27697975 · Agarwal et al., 2016 · Open in CIViC	civic
〃	Thyroid Gland Anaplastic CarcinomaALIAS	Predictive	C	Supports Sensitivity Response	3	submitted	EID12958 This single-patient case report describes a 63-year-old woman diagnosed with BRAF V600E-mutated anaplastic thyroid carcinoma (ATC). Following multiple surgical resections, the patient developed recurr… (full text at CIViC) PMID 37900238 · Lee et al., 2023 · Open in CIViC	civic
Dabrafenib + Pembrolizumab + TrametinibCombination	Thyroid Gland Anaplastic CarcinomaALIAS	Predictive	B	Supports Sensitivity Response	3	submitted	EID13283 In a retrospective single-center cohort of patients with BRAF V600E-mutated anaplastic thyroid carcinoma, 30 patients treated with upfront dabrafenib, trametinib, and pembrolizumab had a significantly… (full text at CIViC) PMID 38226606 · Hamidi et al., 2024 · Open in CIViC	civic
Dabrafenib + TrametinibCombination	Thyroid Gland Papillary CarcinomaALIAS	Predictive	B	Supports Sensitivity Response	3	submitted	EID7762 In a phase 2 trial, patients with radioiodine refractory papillary thyroid carcinoma harboring BRAF mutation were treated with dabrafenib alone or combination with trametinib. 94% of patients had BRAF… (full text at CIViC) Open in CIViC	civic

BRAF V600K5
Dabrafenib + TrametinibCombination	Melanoma	Predictive	B	Supports Sensitivity Response	4	accepted	EID6179 Adjuvant dual treatment with BRAF inhibitor dabrafenib and MEK inhibitor trametinib was administered to patients with stage III resected melenoma with V600E or V600K mutation in this stage III trial (… (full text at CIViC) PMID 28891408 · Long et al., 2017 · Open in CIViC	civic
〃	Melanoma	Predictive	B	Supports Sensitivity Response	3	accepted	EID6939 In this Phase III trial (NCT01584648 COMBI-d), previously untreated patients with unrescectable stage IIIC or IV melanoma with BRAF V600E (359 patients) or V600K (61 patients) received dabrafenib and … (full text at CIViC) PMID 25265492 · Long et al., 2014 · Open in CIViC	civic
〃	Melanoma	Predictive	B	Supports Sensitivity Response	4	accepted	EID6941 In this Phase I and II study (NCT01072175), patients with metastatic melanoma were treated with either a combination of dabrafenib and trametinib or dabrafenib monotherapy. Among patients with the V60… (full text at CIViC) PMID 23020132 · Flaherty et al., 2012 · Open in CIViC	civic
〃	Melanoma	Predictive	B	Supports Sensitivity Response	4	accepted	EID6965 In this Phase III trial (coBRIM, NCT01689519) of 495 V600 mutant melanoma patients, 56 had V600K mutation. 32 patients were treated with vemurafenib and placebo, and 24 were treated with vemurafenib a… (full text at CIViC) PMID 25265494 · Larkin et al., 2014 · Open in CIViC	civic
Trametinib	Melanoma	Predictive	B	Supports Sensitivity Response	2	accepted	EID2506 In a study of 322 advanced melanoma patients with BRAF-V600E (N=281), BRAF-V600K (N=40), or both mutations (N=1), treatment with trametinib was associated with improved progression-free survival (4.8m… (full text at CIViC) PMID 22663011 · Flaherty et al., 2012 · Open in CIViC	civic

NRAS Mutation2
Omipalisib + TrametinibCombination	Melanoma	Predictive	D	Supports Sensitivity Response	4	accepted	EID1429 In six NRAS mutant melanoma cell lines, concomitant use of MEK inhibitor and PI3K/mTOR inhibitor resulted in greater decrease in cell viability than either alone, with the synergistic effect being mar… (full text at CIViC) PMID 23431193 · Posch et al., 2013 · Open in CIViC	civic
Trametinib	Melanoma	Predictive	B	Does Not Support Sensitivity Response	2	accepted	EID1227 Phase 1 trial in 97 patients with melanoma (81 cutaneous or unknown, 16 uveal). Seven patients were found to harbor an NRAS mutation and two of them experienced stable disease (one 48 weeks on treatme… (full text at CIViC) PMID 22805292 · Falchook et al., 2012 · Open in CIViC	civic

KRAS G12/G132
Gemcitabine + TrametinibCombination	Pancreatic Adenocarcinoma	Predictive	B	Supports Resistance	4	accepted	EID622 Adding trametinib to gemcitabine does not improve overall survival (OS), progression-free survival (PFS), overall response rate (ORR) or duration of response (DOR) in patients with untreated metastati… (full text at CIViC) PMID 24915778 · Infante et al., 2014 · Open in CIViC	civic
Trametinib	Pancreatic Adenocarcinoma	Predictive	B	Does Not Support Sensitivity Response	3	accepted	EID990 KRAS G12/G13 status was evaluated in cell-free DNA (cfDNA) of patients with untreated metastatic adenocarcinoma of the pancreas that were randomised (1:1) to receive gemcitabine plus trametinib or pla… (full text at CIViC) PMID 24915778 · Infante et al., 2014 · Open in CIViC	civic

NF1 G629R + NF1 Splice Site (c.205-1G>C)2
Carboplatin + Selumetinib + Trametinib + VincristineSubstitutes	Pilocytic Astrocytoma	Predictive	C	Supports Sensitivity Response	2	submitted	EID12271 This study reported 47 neurofibromatosis type 1 (NF1) patients with biallelic inactivation of NF1 genes were detected in all glial tumors. Targeted capture-based next-generation sequencing (479 cancer… (full text at CIViC) PMID 35945463 · Lucas et al., 2022 · Open in CIViC	civic
〃	Pilocytic Astrocytoma	Predictive	C	Supports Sensitivity Response	2	rejected	EID12359 This study reported 47 neurofibromatosis type 1 (NF1) patients with biallelic inactivation of NF1 genes were detected in all glial tumors. Targeted capture-based next-generation sequencing (479 cancer… (full text at CIViC) PMID 35945463 · Lucas et al., 2022 · Open in CIViC	civic