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.

openfdaRegulatory27 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	—	Efficacy supplement 2025-03-07 (see label)	approved	Mar 7, 2025	openfda
US FDA	—	Efficacy supplement 2025-03-07 (see label)	approved	Mar 7, 2025

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 17 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 1–50 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
RAF1 Amplification1
B-Raf/VEGFR-2 Inhibitor RAF265

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
NCT02465060	Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)	active not recruiting	Phase 2	6,452	National Cancer Institute (NCI)NIH	3	Sep 29, 2026	clinicaltrials
NCT04111458	A Study to Test Different Doses of BI 1701963 Alone and Combined With Trametinib in Patients With Different Types of Advanced Cancer (Solid Tumours With KRAS Mutation)

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 20 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 Fusion4
Everolimus + TrametinibCombination	Childhood Low Grade Glioma	Predictive	D	Supports Sensitivity Response	3	rejected	EID7197 This preclinical study proposed to use a combination therapy of an MEK inhibitor (e.g. trametinib) and an mTOR inhibitor (e.g. everolimus) for the treatment of pediatric low-grade gliomas (PLGGs) with… (full text at CIViC) PMID 29156677 · Jain et al., 2017 · Open in CIViC	civic
〃	Childhood Low Grade Glioma	Predictive	D	Supports Sensitivity Response	2	accepted	EID7199 This preclinical study proposed to use a combination therapy of an MEK inhibitor (e.g. trametinib) and an mTOR inhibitor (e.g. everolimus) for the treatment of pediatric low-grade gliomas (PLGGs) with… (full text at CIViC) PMID 29156677 · Jain et al., 2017 · Open in CIViC	civic
Trametinib	Childhood Pilocytic Astrocytoma	Predictive	D	Supports Sensitivity Response	3	accepted	EID8944 In this preclinical experiment, a pediatric pilocytic astrocytoma cell line (DKFZ-BT66) harboring KIAA1549:BRAF fusion was generated from a two year old patient. Treatment with trametinib resulted in … (full text at CIViC) PMID 28002790 · Selt et al., 2017 · Open in CIViC	civic
〃	Cutaneous MelanomaALIAS	Predictive	C	Supports Sensitivity Response	1	accepted	EID1571 A 65 yr old male patient with metastatic acral lentiginous melanoma (BRAF, NRAS, KIT negative) was found to harbor a KIAA1549-BRAF (intron 15-intron 8) fusion in a subcutaneous metastasis sample after… (full text at CIViC) PMID 26072686 · Menzies et al., 2015 · Open in CIViC	civic

BRAF V600E8
Dabrafenib + TrametinibCombination	Cholangiocarcinoma	Predictive	B	Supports Sensitivity Response	3	submitted	EID7453 In NCI-MATCH trial, patients with advanced solid tumors, lymphoma or multiple myeloma harboring BRAF V600E mutation were treated with dabrafenib and trametinib. Patients with melanoma, thyroid carcino… (full text at CIViC) Open in CIViC	civic
〃	Cholangiocarcinoma	Predictive	C	Supports Sensitivity Response	3	accepted	EID5902 Chemotherapy-refractory, metastatic cholangiocarcinoma with CNS involvement and a BRAF V600E mutation had a partial response at 8 weeks to dabrafenib and trametinib combination with complete radiologi… (full text at CIViC) PMID 28480077 · Kocsis et al., 2017 · Open in CIViC	civic
〃	Cutaneous MelanomaALIAS	Predictive	B	Supports Sensitivity Response	4	accepted	EID3758 In a clinical trial (NCT01597908) of 704 metastatic melanoma patients, patients harboring a BRAF V600E mutation and treated with vemurafenib (n=317) were associated with a 51% response rate, as compar… (full text at CIViC) PMID 25399551 · Robert et al., 2015 · Open in CIViC	civic
Dabrafenib + Trametinib + VemurafenibCombination	Digestive System Neuroendocrine TumorALIAS	Predictive	C	Supports Sensitivity Response	3	accepted	EID1430 BRAF mutations were identified in 9% of 108 cases of high-grade colorectal neuroendocrine tumors (80% V600E). Two patients were treated with a combination of BRAF and MEK inhibition and exhibited dura… (full text at CIViC) PMID 27048246 · Klempner et al., 2016 · Open in CIViC	civic
Dabrafenib + TrametinibCombination	Intrahepatic Cholangiocarcinoma	Predictive	C	Supports Sensitivity Response	3	accepted	EID5903 Two cases of patients with BRAF V600E positive, refractory intrahepatic cholangiocarcinoma showed excellent clinical and radiographic response to combination dabrafenib and trametinib treatment. One p… (full text at CIViC) PMID 28078132 · Lavingia et al., 2016 · Open in CIViC	civic
〃	Intrahepatic Cholangiocarcinoma	Predictive	C	Supports Sensitivity Response	3	accepted	EID5904 Dabrafenib and trametinib combination showed durable response for a patient with standard chemotherapy and radiation refractory, poorly differentiated, intrahepatic cholangiocarcinoma harboring BRAF V… (full text at CIViC) PMID 25435907 · Loaiza-Bonilla et al., 2014 · Open in CIViC	civic
Dabrafenib + TrametinibCombination	Low Grade Glioma	Predictive	A	Supports Sensitivity Response	4	accepted	EID12162 In this trial, patients with pediatric (age <18 years) low-grade gliomas harbouring BRAF V600E (n=49), were treated with either trametinib monotherapy (n=13) or dabrafenib + trametinib (n=36). In pati… (full text at CIViC) PMID 36375115 · Bouffet et al., 2023 · Open in CIViC	civic
Dabrafenib + TrametinibCombination	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	A	Supports Sensitivity Response	4	accepted	EID3017 Patients with BRAF V600E-mutant NSCLC (n=57) were enrolled into a phase 2, multicentre, non-randomised, open-label study, administering dabrafenib plus trametinib. The overall response rate was 36/57 … (full text at CIViC) PMID 27283860 · Planchard et al., 2016 · Open in CIViC	civic

BRAF L597Q2
Trametinib	Cutaneous MelanomaALIAS	Predictive	C	Supports Sensitivity Response	3	accepted	EID4905 Case study report including one patient with L597Q mutation-positive metastatic melanoma (M1b disease) treated with the MEK inhibitor trametinib. The L597Q patient achieved a RECIST partial response a… (full text at CIViC) PMID 24933606 · Bowyer et al., 2014 · Open in CIViC	civic
Trametinib + VemurafenibSubstitutes	Cutaneous MelanomaALIAS	Predictive	D	Supports Sensitivity Response	2	accepted	EID1461 Preclinical study in 293H cell line. Ectopic expression of V600E, L597R/Q/S, and K601E mutants elevated phospho-MEK and ERK levels. Vemurafenib treatment of all of the BRAF mutant–expressing cells led… (full text at CIViC) PMID 22798288 · Dahlman et al., 2012 · Open in CIViC	civic

BRAF G596C2
Dabrafenib + TrametinibCombination	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	2	accepted	EID1738 Non-V600 BRAF mutations occur in about half of BRAF-mutated lung cancers, and their sensitivity to Dabrafenib and Trametinib is not well documented. In a cohort of 229 NSCLC patients that underwent mo… (full text at CIViC) PMID 28947956 · Noeparast et al., 2017 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	3	rejected	EID9514 Non-V600 BRAF mutations occur frequently in NSCLC. While BRAF G596C results in impaired kinase activity, it can induce MEK/ERK activation when expressed in HEK293T cells in the presence of RAF1 (CRAF)… (full text at CIViC) PMID 28947956 · Noeparast et al., 2017 · Open in CIViC	civic

KRAS Mutation4
Afatinib + TrametinibCombination	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	2	accepted	EID992 An shDNA screen identified synergy between ERBB3 Inhibition and MEK Inhibition in KRAS mutated cell lines. Dual EGFR/ERBB2 Inhibitors afatinib and dacomitinib and MEK Inhibition was synergistic in col… (full text at CIViC) PMID 24685132 · Sun et al., 2014 · Open in CIViC	civic
Trametinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	2	accepted	EID1220 In a phase 1 clinical trial for the use of trametinib for various advanced solid tumors, 22 out of 30 NSCLC patients harbored KRAS mutations. Of those 22 patients with mutant KRAS, 8 saw reductions in… (full text at CIViC) PMID 22805291 · Infante et al., 2012 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Does Not Support Sensitivity Response	4	accepted	EID4867 In this phase II trial, trametinib or docetaxel was given to patients with advanced KRAS-mutant NSCLC. Median PFS was 12 weeks in the trametinib arm and 11 weeks in the docetaxel arm (HR 1.14; p = 0.5… (full text at CIViC) PMID 25722381 · Blumenschein et al., 2015 · Open in CIViC	civic
Docetaxel + Pemetrexed + TrametinibCombination	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	accepted	EID4862 This phase I/Ib two-part study evaluated trametinib in combination with anticancer agents docetaxel or pemetrexed in NSCLC with and without KRAS mutations. Confirmed partial response (PR) was observed… (full text at CIViC) PMID 27876675 · Gandara et al., 2017 · Open in CIViC	civic