Trametinib
Approved · EMAAlso known as Mekinist, Tramétinib, Trametinibum.
Recent clinical, regulatory, research and industry developments relating to this drug.
Molecular Analysis for Therapy Choice (MATCH)
Drug Safety Update: Trametinib (Mekinist▼): risk of gastrointestinal perforation and colitis
Improved overall survival in melanoma with combined dabrafenib and trametinib.
Combined BRAF and MEK inhibition versus BRAF inhibition alone in melanoma.
Improved survival with MEK inhibition in BRAF-mutated melanoma.
Profile
Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.
Pharmacology & targets
Known molecular targets and mechanisms supported by curated pharmacology databases.
Regulatory timeline
The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.
Indication: Low-grade glioma Spexotras in combination with dabrafenib is indicated for the treatment of paediatric patients aged 1 year and older with low-grade glioma (LGG) with a BRAF… Show full indicationShow less
Low-grade glioma Spexotras in combination with dabrafenib is indicated for the treatment of paediatric patients aged 1 year and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. High-grade glioma Spexotras in combination with dabrafenib is indicated for the treatment of paediatric patients aged 1 year and older with high-grade glioma (HGG) with a BRAF V600E mutation who have received at least one prior radiation and/or chemotherapy treatment.
Indication: Melanoma Trametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adults and adolescents aged 12 years and older with… Show full indicationShow less
Melanoma Trametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adults and adolescents aged 12 years and older with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1). Trametinib monotherapy has not demonstrated clinical activity in patients who have progressed on a prior BRAF inhibitor therapy (see section 5.1). Adjuvant treatment of melanoma Trametinib in combination with dabrafenib is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage III melanoma with a BRAF V600 mutation, following complete resection. Non-small cell lung cancer (NSCLC) Trametinib in combination with dabrafenib is indicated for the treatment of adults with advanced non-small cell lung cancer with a BRAF V600 mutation. Differentiated thyroid cancer (DTC) Trametinib in combination with dabrafenib is indicated for the treatment of adult patients with locally advanced or metastatic differentiated thyroid cancer with a BRAF V600E mutation, refractory to or not eligible for radioactive iodine (RAI) who have progressed during or after prior systemic therapy (for biomarker-based patient selection, see section 4.2).
Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.
Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).
Clinical trials
The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.
Late-stage studies
Phase III+ trials still open or recently active — where late-stage evidence is being generated.
Recent completions
Trials that read out recently, adding to the completed evidence base.
Research activity
Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.
Major research themes2
Journals, researchers & institutions
- The New England journal of medicine3
- Journal of clinical oncology : official journal of the American Society of Clinical Oncology1
- Martin AM3
- Nathan P3
- Ribas A3
- Robert C3
- Schadendorf D3
- Casey M2
- Dummer R2
- Flaherty K2
- AIM at Melanoma Foundation1
- Cleveland Clinic Taussig Cancer Center1
- CoxHealth South Hospital1
- Dana-Farber Cancer Institute and Harvard Medical School1
- Georgetown Lombardi Comprehensive Cancer Center1
- Greater Baltimore Medical Center1
Related diseases
Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.
Related drugs
Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).
Studied across 3 of the same disease areas as Trametinib in the shared literature.
Studied across 2 of the same disease areas as Trametinib in the shared literature.
- RxNorm (U.S. National Library of Medicine) — drug identity
- ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
- Europe PMC — research literature
- ClinicalTrials.gov — clinical trials
- Regulatory event sources are credited in the Regulatory Timeline above.