Overview
Trametinib is an orally bioavailable mitogen-activated extracellular signal-regulated kinase 1 (MEK1) and MEK2 inhibitor. It was first approved by the FDA in May 2013 for the treatment of melanoma. It was later approved by Health Canada on July 18, 2013 and by the European Commission on June 30, 2014. Trametinib is currently approved to treat a variety of cancers with BRAF mutations, such as non-small cell lung cancer and thyroid cancer, as monotherapy or in combination with dabrafenib, a BRAF inhibitor, for improved therapeutic efficacy. Originally developed by Japan Tobacco, trametinib was initially investigated for treating inflammation, but further studies for this indication were not pursued.
Indication
Trametinib is indicated as monotherapy for the treatment of BRAF-inhibitor treatment-naïve patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations. It is used in combination with dabrafenib for the: In the US, BRAF V600E or V600K mutations must be detected by an FDA-approved test. Trametinib is not indicated for the treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition.
Associated Conditions
- Advanced Non-Small Cell Lung Cancer (NSCLC)
- Locally Advanced Anaplastic Thyroid Cancer
- Low-Grade Glioma
- Melanoma
- Metastatic Anaplastic Thyroid Cancer
- Metastatic Melanoma
- Metastatic Non-Small Cell Lung Cancer
- Stage III Melanoma
- Unresectable Melanoma
- Unresectable or Metastatic Solid Tumors
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/08 | Phase 4 | Not yet recruiting | Fujian Medical University | ||
2025/05/08 | Phase 1 | Recruiting | |||
2025/02/03 | Phase 1 | Recruiting | |||
2024/12/18 | Phase 2 | Recruiting | Tianjin Medical University Second Hospital | ||
2024/12/02 | Phase 1 | Recruiting | |||
2024/10/22 | Phase 2 | Recruiting | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | ||
2024/09/03 | Phase 2 | Recruiting | |||
2024/08/15 | Phase 2 | Recruiting | Medical University of Warsaw | ||
2024/08/01 | N/A | Recruiting | |||
2024/06/26 | Phase 3 | Recruiting | ECOG-ACRIN Cancer Research Group |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Novartis Pharmaceuticals Corporation | 0078-1112 | ORAL | 2 mg in 1 1 | 3/16/2023 | |
| Novartis Pharmaceuticals Corporation | 0078-1161 | ORAL | 0.05 mg in 1 mL | 3/16/2023 | |
| Novartis Pharmaceuticals Corporation | 0078-1105 | ORAL | .5 mg in 1 1 | 3/16/2023 | |
| Novartis Pharmaceuticals Corporation | 0078-0668 | ORAL | 2 mg in 1 1 | 3/16/2023 | |
| Novartis Pharmaceuticals Corporation | 0078-0666 | ORAL | .5 mg in 1 1 | 3/16/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 1/5/2024 | ||
Authorised | 6/30/2014 | ||
Authorised | 1/5/2024 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| MEKINIST FILM-COATED TABLETS 2MG | SIN15182P | TABLET, FILM COATED | 2mg | 2/27/2017 | |
| MEKINIST FILM-COATED TABLETS 0.5MG | SIN15181P | TABLET, FILM COATED | 0.5mg | 2/27/2017 | |
| MEKINIST® POWDER FOR ORAL SOLUTION 4.7 MG | SIN17018P | POWDER, FOR SOLUTION | 4.7 mg | 6/3/2024 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Trametinib tablets | 国药准字HJ20190068 | 化学药品 | 片剂 | 9/10/2024 | |
| Trametinib tablets | 国药准字HJ20190069 | 化学药品 | 片剂 | 9/10/2024 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| MEKINIST trametinib (as dimethyl sulfoxide) 0.05 mg/mL powder for oral solution bottle | 397190 | Medicine | A | 12/6/2023 | |
| MEKINIST trametinib 2 mg (as dimethyl sulfoxide) tablet HDPE bottle and CRC | 205919 | Medicine | A | 2/14/2014 | |
| MEKINIST trametinib 0.5 mg (as dimethyl sulfoxide) tablet HDPE bottle and CRC | 205917 | Medicine | A | 2/14/2014 |
Help Us Improve
Your feedback helps us provide better drug information and insights.