Trametinib clinical trials
Trametinib is named as an intervention in 46 current clinical trials in our China, USA, France, Canada, Italy, Netherlands, Israel, Germany, Spain, Norway, Australia, UK, Belgium, Denmark, Mexico, Japan, South Korea, Taiwan, Austria, Czechia, Sweden, Switzerland, Poland, Brazil, Ireland, Turkey, Egypt, Portugal, India and Singapore registers. 21 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Novartis Pharmaceuticals (7). The most-studied condition is Melanoma. The EU clinical trials register (CTIS) separately lists 2 authorised or ongoing trials.
Where Trametinib is approved
All regulators →Of the three regulators tracked here, the first to approve Trametinib was Canada, on 18 Jul 2013. It is approved in 3 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Trametinib patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Trametinib, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- Spexotras for treatment of glioma: until 8 Jan 2036 (includes 24 months' paediatric extension). Union Register
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
How Trametinib works
All drug targets →- Dual specificity mitogen-activated protein kinase kinase 2 inhibitor InhibitorTarget: MAP2K2 mitogen-activated protein kinase kinase 2✓ In ChEMBL and the Guide to Pharmacology
- Dual specificity mitogen-activated protein kinase kinase 1 inhibitor InhibitorTarget: MAP2K1 mitogen-activated protein kinase kinase 1✓ In ChEMBL and the Guide to Pharmacology
- Dual specificity mitogen-activated protein kinase kinase; MEK1/2 inhibitor InhibitorTarget: Dual specificity mitogen-activated protein kinase kinase; MEK1/2✓ In ChEMBL and the Guide to Pharmacology
- Cutaneous melanomaPhase 3
- Differentiated thyroid carcinomaPhase 3
- Soft tissue sarcomaPhase 3
- Thyroid cancerPhase 3
- AmeloblastomaPhase 2/3
- Peritoneum cancerPhase 2/3
- Erdheim-Chester diseasePhase 2
- HistiocytosisPhase 2
- Langerhans cell histiocytosisPhase 2
- Noonan syndromePhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL2103875, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 6495, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Trametinib
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 1 technology appraisal of Trametinib. 1 is current, and 1 of it recommends it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Trametinib in combination with dabrafenib for treating unresectable or metastatic melanoma NICE TA396 | Recommended | 22 Jun 2016 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Trametinib
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 3 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EU
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Trametinib
- ATC code
- L01XE25
- ChEMBL
- CHEMBL2103875
- DrugBank
- DB08911
- PubChem CID
- 11707110
- CAS number
- 871700-17-3
- FDA UNII
- 33E86K87QN
- Wikidata
- Q7833138
- Wikipedia
- Trametinib
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Trametinib
46 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Trametinib in the EU trials register (CTIS)
2 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Trametinib. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
DYNAMIC ” IDentifY the best therapeutic sequeNcing strAtegy in oncogene addICted NSCLC:”
“A multi-arms prospective, randomized phase II study to evaluate the best sequential
therapeutic strategis in patients with metastatic non-small cell lung cancer harboring
targetable genomic driver alterations”
2026-525268-16-00 · CTIS ↗ · Neoplasms
|
Phase 3 | Authorised | Universita' Degli Studi Di Torino | Italy |
|
TAILOR-PANC: Molecularly Tailored Therapy versus Standard Care in Advanced Pancreatic Cancer (DPCG-02)
2025-522431-34-00 · CTIS ↗ · Neoplasms
|
Phase 2 | Authorised | Region Hovedstaden | Denmark |
Trametinib across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
3 single-substance products containing Trametinib on the HPRA medicines list.
- Mekinist 0.5 mg film-coated tabletsNovartis Europharm Limited · EU/1/14/931/01-02
- Mekinist 1 mg film-coated tabletsNovartis Europharm Limited · EU/1/14/931/03-04
- Mekinist 2 mg film-coated tabletsNovartis Europharm Limited · EU/1/14/931/05-06
Supply shortages
No entry for Trametinib in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Trametinib
78 conditionsAll 78 conditions
| Condition (as registered) | Trials |
|---|---|
| Melanoma | 5 |
| Advanced Solid Tumors | 3 |
| Cancer | 2 |
| Anaplastic Astrocytoma | 2 |
| Multiple Myeloma | 2 |
| Solid Tumor | 2 |
| Metastatic Melanoma | 2 |
| Acute Lymphoblastic Leukemia, in Relapse | 1 |
| Lymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Recurrent | 1 |
| Lymphoblastic Lymphoma (Precursor T-Lymphoblastic Lymphoma/Leukaemia) Recurrent | 1 |
| Lymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Refractory | 1 |
| Diffuse Astrocytoma | 1 |
| Astrocytoma | 1 |
| Oligodendroglioma, Childhood | 1 |
| Advanced or Metastatic NRAS-mutant Melanoma | 1 |
| Advanced or Metastatic Solid Tumors | 1 |
| Kirsten Rat Sarcoma (KRAS) pG12C Mutation | 1 |
| Solid Tumors, KRAS Mutation; SOS1 | 1 |
| Non Small Cell Lung Cancer | 1 |
| Rare Cancers | 1 |
| Cholangiocarcinoma | 1 |
| Differentiated Thyroid Cancer (DTC) | 1 |
| Vascular Anomalies | 1 |
| KRAS Mutation-Related Tumors | 1 |
| Advanced Lung Cancer | 1 |
| Refractory Tumor | 1 |
| Solid Tumor Cancer | 1 |
| Thyroid Neoplasms | 1 |
| AML, Adult | 1 |
| Locally Advanced or Metastatic KRAS G12C-mutated Non-small Cell Lung Cancer | 1 |
| Advanced Solid Tumors Harboring the KRAS G12C Mutation | 1 |
| Locally Advanced Thyroid Gland Carcinoma | 1 |
| NSCLC | 1 |
| BRAF V600 Mutation | 1 |
| MET Exon 14 Mutation | 1 |
| Precision Medicine | 1 |
| Ameloblastoma | 1 |
| BRAF V600E Mutation Positive | 1 |
| Advanced Thyroid Cancer Patients Who Received Target Therapy | 1 |
| Lung Cancer Stage III | 1 |
| Mutation | 1 |
| EGFR-mutant Non-small Cell Lung Cancer | 1 |
| Recurrent Uveal Melanoma | 1 |
| Stage IV Uveal Melanoma AJCC v7 | 1 |
| Grade 1 Glioma | 1 |
| Mixed Glio-neuronal Tumors | 1 |
| Pleomorphic Xanthoastrocytoma | 1 |
| Meningioma | 1 |
| Malignant Solid Tumor | 1 |
| Fertility | 1 |
| Tumors | 1 |
| Neoplasm | 1 |
| Neoplasia | 1 |
| Malignant Melanoma | 1 |
| Histiocytosis | 1 |
| Cardiomegaly | 1 |
| Noonan Syndrome | 1 |
| Rare Malignant Neoplasm | 1 |
| Lymphoma, Non-Hodgkin | 1 |
| Advanced Lymphoma | 1 |
| Advanced Malignant Solid Neoplasm | 1 |
| Bladder Carcinoma | 1 |
| Breast Carcinoma | 1 |
| Low-grade Glioma | 1 |
| Plexiform Neurofibroma | 1 |
| Central Nervous System Glioma | 1 |
| KRAS Gene Mutation | 1 |
| Recurrent Lung Non-Small Cell Carcinoma | 1 |
| Stage IV Lung Non-Small Cell Cancer AJCC v7 | 1 |
| Stage III Cutaneous Melanoma AJCC v7 | 1 |
| Stage IV Cutaneous Melanoma AJCC v6 and v7 | 1 |
| Unresectable Melanoma | 1 |
| Anaplastic Astrocytoma, Not Otherwise Specified | 1 |
| Anaplastic Ganglioglioma | 1 |
| Anaplastic Pleomorphic Xanthoastrocytoma | 1 |
| Clinical Stage III Cutaneous Melanoma AJCC v8 | 1 |
| Clinical Stage IV Cutaneous Melanoma AJCC v8 | 1 |
| Recurrent Melanoma | 1 |
Sponsors
lead sponsor per trial+ 16 more sponsors in the trial list above.
By country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Trametinib trials
How many clinical trials are testing Trametinib?
46 current trials in our China, USA, France, Canada, Italy, Netherlands, Israel, Germany, Spain, Norway, Australia, UK, Belgium, Denmark, Mexico, Japan, South Korea, Taiwan, Austria, Czechia, Sweden, Switzerland, Poland, Brazil, Ireland, Turkey, Egypt, Portugal, India and Singapore registers name Trametinib (also registered as TMT212) as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Trametinib trials recruiting patients?
Yes. 21 of the 46 trials are recruiting: 9 with sites in China, 5 with sites in USA, 5 with sites in France, 3 with sites in Canada, 3 with sites in Italy, 4 with sites in Netherlands, 2 with sites in Israel, 3 with sites in Germany, 4 with sites in Spain, 5 with sites in Norway, 2 with sites in Australia, 2 with sites in UK, 2 with sites in Belgium, 4 with sites in Denmark, 2 with sites in Mexico, 2 with sites in Japan, 1 with sites in South Korea, 2 with sites in Taiwan, 3 with sites in Austria, 2 with sites in Czechia, 2 with sites in Sweden, 2 with sites in Switzerland, 2 with sites in Poland, 1 with sites in Brazil, 2 with sites in Ireland, 1 with sites in Turkey and 1 with sites in Portugal. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Trametinib clinical trials?
Novartis Pharmaceuticals (7), National Cancer Institute (NCI) (6), Bristol-Myers Squibb (2) and Erasca, Inc (2), among 31 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Are there Trametinib clinical trials in Ireland?
Yes. 2 trials in our Ireland register (ClinicalTrials.gov). Some may be the same study registered in both. See the Irish clinical trials register for sites and contacts.
Is Trametinib licensed in Ireland?
Yes. The HPRA medicines list includes 3 single-substance products containing Trametinib, for example Mekinist 0.5 mg film-coated tablets (Novartis Europharm Limited). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Trametinib shortage?
Not in the lists we track: Trametinib has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Trametinib works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Trametinib works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Trametinib (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.