Drugs / Trametinib
Trametinib
also known as
GSK1120212 · Mekinist · Trametinib Dimethyl Sulfoxide · GSK1120212B · MEK Inhibitor Trametinib GSK1120212 · MEKINISTR · TMT212
Small molecule targets BRAF, HRAS, KRAS, MAP2K1, MAP2K2, NF1, NRAS, PTPN11 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | MEKINIST | — | 2025-03-07 | fda.gov ↗ |
| Approved | US (FDA) | MEKINIST | — | 2023-03-16 | fda.gov ↗ |
| Approved | EU (EMA) | Mekinist | — | 2014-06-30 | europa.eu ↗ |
Trials 252 · started per year
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EU approved 2014
US approved 2023
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT03085056 | Mar 2017 → Sep 2026 expected | thyroid gland undifferentiated (anaplastic) carcinoma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 0 | NCT01467310 | Jan 2012 → Mar 2016 | breast cancer | UNC Lineberger Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 176 trials | ||||||
| Phase 1 | NCT06962254 | May 2025 → Mar 2028 expected | — | China Medical University Hospital | Recruiting | No outcome recorded |
| Phase 1 | NCT06804824 | Feb 2025 → Aug 2027 expected | cancer | Vividion Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT05907304 | Aug 2023 → Jul 2025 overdue | — | Erasca, Inc. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05440942 | Jan 2023 → May 2025 | pancreatic ductal adenocarcinoma | Peter Hosein, MD | Completed | No outcome recorded |
| Phase 1 | NCT05668585 | Dec 2022 → Nov 2025 | melanoma, non-small cell lung carcinoma | C4 Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04454476 | Nov 2022 → Dec 2024 overdue | gastric cancer, gastric intestinal metaplasia | Vanderbilt-Ingram Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05435846 | Aug 2022 → Nov 2023 | non-small cell lung carcinoma | Collin Blakely | Terminated | No outcome recorded |
| Phase 1 | NCT05616923 | Nov 2021 → Dec 2022 | rosacea | Albany Research Institute, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05048134 | Oct 2021 → Feb 2023 | cancer | Jiangsu HengRui Medicine Co., Ltd. | Terminated | No outcome recorded |
| Phase 1 | NCT04967079 | Aug 2021 → Jul 2023 | non-small cell lung carcinoma | Shanghai Chest Hospital | Completed | No outcome recorded |
| Phase 1 | NCT04892017 | Jun 2021 → Mar 2026 | metastatic neoplasm, non-small cell lung carcinoma | Deciphera Pharmaceuticals, LLC | Terminated | No outcome recorded |
| Phase 1 | NCT04485559 | Dec 2020 → Dec 2027 expected | grade II glioma, high grade astrocytic tumor | University of California, San Francisco | Recruiting | No outcome recorded |
| Phase 1 | NCT03975231 | Sep 2020 → Oct 2027 expected | thyroid gland undifferentiated (anaplastic) carcinoma | City of Hope Medical Center | Recruiting | No outcome recorded |
| Phase 1 | NCT04294160 | Jul 2020 → Sep 2024 | colorectal cancer | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 1 | NCT03878524 | Apr → Dec 2020 | acute myeloid leukemia, atypical chronic myeloid leukemia, BCR-ABL1 negative, blast phase chronic myelogenous leukemia, BCR-ABL1 positive, castration-resistant prostate carcinoma +14 | OHSU Knight Cancer Institute | Terminated | No outcome recorded |
| Phase 1 | NCT04185883 | Dec 2019 → Dec 2026 expected | cancer | Amgen | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04111458 | Nov 2019 → Dec 2027 expected | — | Boehringer Ingelheim | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03631953 | Sep 2019 → Jan 2026 overdue | meningioma | Assistance Publique Hopitaux De Marseille | Recruiting | No outcome recorded |
| Phase 1 | NCT03272464 | May → Jul 2019 | melanoma | Massachusetts General Hospital | Terminated | No outcome recorded |
| Phase 1 | NCT03825289 | Jan 2019 → Jan 2025 | malignant pancreatic neoplasm, metastatic carcinoma | University of Utah | Terminated | No outcome recorded |
| Phase 1 | NCT03714958 | Dec 2018 → Sep 2023 | colorectal cancer, metastatic malignant neoplasm | Centre Leon Berard | Completed | No outcome recorded |
| Phase 1 | NCT04303403 | Jul 2018 → Jun 2023 | colorectal cancer, pancreatic adenocarcinoma | National Cancer Centre, Singapore | Unknown | No outcome recorded |
| Phase 1 | NCT03501368 | Jun 2018 → Oct 2022 | melanoma | H. Lee Moffitt Cancer Center and Research Institute | Completed | No outcome recorded |
| Phase 1 | NCT03299088 | Jun 2018 → Jan 2021 | non-small cell lung carcinoma | Jonathan Riess | Completed | No outcome recorded |
| Phase 1 | NCT03516214 | Apr 2018 → Sep 2022 | bronchial neoplasm | University of Cologne | Completed | No outcome recorded |
| Phase 1 | NCT03317119 | Apr 2018 → Jul 2023 | colon carcinoma, rectal carcinoma | City of Hope Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT03434262 | Mar 2018 → Sep 2022 | IDH-wildtype glioblastoma, RELA fusion-positive ependymoma, anaplastic ependymoma, anaplastic ganglioglioma +19 | St. Jude Children's Research Hospital | Completed | No outcome recorded |
| Phase 1 | NCT03333343 | Jan 2018 → Oct 2026 expected | non-small cell lung carcinoma | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03065387 | Oct 2017 → Oct 2028 expected | metastatic malignant neoplasm, refractory malignant neoplasm | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03087448 | Sep 2017 → Apr 2022 | non-small cell lung carcinoma | University of California, San Francisco | Terminated | No outcome recorded |
| Phase 1 | NCT03088176 | Jun 2017 → Nov 2020 | melanoma | West Cancer Center | Unknown | No outcome recorded |
| Phase 1 | NCT03091257 | Jun 2017 → Jul 2026 overdue | plasma cell myeloma | Massachusetts General Hospital | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02447939 | May 2017 → Oct 2018 | melanoma | GlaxoSmithKline | Withdrawn | No outcome recorded |
| Phase 1 | NCT02939846 | May 2017 → Aug 2018 | cancer | GlaxoSmithKline | Withdrawn | No outcome recorded |
| Phase 1 | NCT02974725 | Feb 2017 → Apr 2024 | melanoma, non-small cell lung carcinoma | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 1 | NCT02705963 | Oct 2016 → Aug 2019 | cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02915666 | Oct 2016 → Jul 2017 | melanoma | University of Texas Southwestern Medical Center | Withdrawn | No outcome recorded |
| Phase 1 | NCT02900664 | Aug 2016 → Mar 2021 | colorectal cancer, non-small cell lung carcinoma, triple-negative breast carcinoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02703571 | Jun 2016 → Sep 2019 | colorectal cancer | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 1 | NCT02292732 | Feb 2016 → May 2017 | cancer | GlaxoSmithKline | Withdrawn | No outcome recorded |
| Phase 1 | NCT02300935 | Dec 2015 → Jan 2016 | melanoma | SCRI Development Innovations, LLC | Withdrawn | No outcome recorded |
| Phase 1 | NCT02357732 | Aug 2015 | metastatic melanoma | University of Pittsburgh | Withdrawn | No outcome recorded |
| Phase 1 | NCT02538627 | Aug 2015 → Oct 2016 | colorectal cancer, head and neck squamous cell carcinoma, non-small cell lung carcinoma | Merrimack Pharmaceuticals | Terminated | No outcome recorded |
| Phase 1 | NCT02258607 | Mar 2015 → Jul 2016 | — | Sierra Oncology LLC - a GSK company | Terminated | No outcome recorded |
| Phase 1 | NCT02292173 | Feb 2015 → Dec 2018 | hepatocellular carcinoma | H. Lee Moffitt Cancer Center and Research Institute | Completed | No outcome recorded |
| Phase 1 | NCT02138292 | Jul 2014 → Feb 2017 | melanoma | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT02097225 | May 2014 → Mar 2019 | cutaneous melanoma, metastatic malignant neoplasm, metastatic melanoma | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 1 | NCT02015117 | Apr 2014 → Jul 2020 overdue | metastatic malignant neoplasm in the brain | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02065063 | Apr 2014 → Jun 2016 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT02016729 | Apr 2014 → Apr 2017 | acute myeloid leukemia | Kartos Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02070549 | Mar 2014 → Dec 2024 | metastatic malignant neoplasm | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT02027961 | Dec 2013 → Apr 2018 | melanoma | MedImmune LLC | Completed | No outcome recorded |
| Phase 1 | NCT01938443 | Nov 2013 → Jun 2016 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01912625 | Oct 2013 → Nov 2017 | non-small cell lung carcinoma | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 1 | NCT01938456 | Oct 2013 → Jul 2014 | non-small cell lung carcinoma | GlaxoSmithKline | Withdrawn | No outcome recorded |
| Phase 1 | NCT01935973 | Sep 2013 → Sep 2015 | endometrial clear cell adenocarcinoma, endometrial mixed adenocarcinoma, endometrial serous adenocarcinoma, endometrial undifferentiated carcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT01940809 | Aug 2013 → Jul 2020 | cutaneous melanoma, metastatic melanoma | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 1 | NCT01767454 | Feb 2013 → Sep 2015 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01725100 | Feb 2013 → Jan 2015 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01740648 | Nov 2012 → Sep 2021 | rectal carcinoma | Ohio State University Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT01658553 | Sep 2012 → Apr 2014 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01647659 | Jul → Nov 2012 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01476137 | Oct 2011 → Mar 2013 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01438554 | Oct 2011 → Apr 2016 | cholangiocarcinoma, soft tissue sarcoma, thyroid cancer | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed | No outcome recorded |
| Phase 1 | NCT01416337 | Jun → Dec 2011 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01371487 | May → Sep 2011 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01387204 | Feb → Jul 2011 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01324258 | Jan 2011 → Jul 2013 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01248858 | Dec 2010 → Jan 2014 | cancer | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 1 | NCT01192165 | Sep 2010 → Oct 2013 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01138085 | May 2010 → Nov 2014 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01287546 | Apr 2010 → Jan 2015 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01155453 | Apr 2010 → Nov 2014 | — | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT00955773 | Aug 2009 → Nov 2011 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01428427 | Aug 2009 → Jul 2011 | acute myeloid leukemia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00687622 | Jul 2008 → Jun 2011 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1/233 trials | ||||||
| Phase 1/2 | NCT07468071 | Jun 2026 → Jun 2029 expected | — | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05275374 | Dec 2025 → Dec 2027 expected | colorectal cancer, melanoma, non-small cell lung carcinoma, thyroid cancer | Xynomic Pharmaceuticals, Inc. | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07072403 | Jul 2025 → Jul 2027 expected | vascular malformation | West China Hospital | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT06712875 | Apr 2025 → Dec 2028 expected | low grade glioma | Ann & Robert H Lurie Children's Hospital of Chicago | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05849662 | Oct 2024 → Dec 2028 expected | CBL-related disorder, juvenile myelomonocytic leukemia, neurofibromatosis type 1 | Therapeutic Advances in Childhood Leukemia Consortium | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06456138 | Jul 2024 → Jun 2026 overdue | non-small cell lung carcinoma, refractory malignant neoplasm | Shanghai Chest Hospital | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT05658640 | Nov 2023 → Apr 2029 expected | T-lymphoblastic lymphoma, acute lymphoblastic leukemia | Princess Maxima Center for Pediatric Oncology | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05874414 | Aug 2023 → Dec 2027 expected | cholangiocarcinoma | Genfit | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05677373 | Jan 2023 → Jul 2025 | uveal melanoma | Alliance for Clinical Trials in Oncology | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT05358249 | Oct 2022 → Sep 2026 expected | colorectal carcinoma, non-small cell lung carcinoma | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05372354 | Oct 2022 → Oct 2026 expected | plasma cell myeloma | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05071183 | Sep 2021 → Mar 2023 | metastatic neoplasm | Turning Point Therapeutics, Inc. | Terminated | No outcome recorded |
| Phase 1/2 | NCT04557956 | Aug 2021 → Oct 2025 overdue | cutaneous melanoma, metastatic melanoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04326283 | Apr 2020 → Apr 2023 | amyotrophic lateral sclerosis | Genuv Inc. | Terminated | No outcome recorded |
| Phase 1/2 | NCT04201457 | Jan 2020 → Mar 2026 overdue | low grade glioma | Pediatric Brain Tumor Consortium | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03704688 | Oct 2018 → Feb 2022 | non-small cell lung carcinoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1/2 | NCT03455764 | Sep 2018 → Sep 2023 | melanoma | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 1/2 | NCT03580382 | Jul → Sep 2018 | melanoma | NYU Langone Health | Terminated | No outcome recorded |
| Phase 1/2 | NCT03225664 | Feb 2018 → Dec 2027 expected | non-small cell lung carcinoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03377361 | Jan 2018 → Nov 2024 | colorectal carcinoma | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1/2 | NCT03754179 | Jan 2018 → Dec 2021 | melanoma | University Hospital Brussels | Unknown | No outcome recorded |
| Phase 1/2 | NCT03076164 | Mar 2017 → Dec 2020 | lung adenocarcinoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1/2 | NCT02580708 | Sep 2015 → May 2016 | non-small cell lung carcinoma | Clovis Oncology, Inc. | Terminated | No outcome recorded |
| Phase 1/2 | NCT02392871 | May 2015 → Sep 2019 | metastatic melanoma | Melanoma and Skin Cancer Trials Limited | Completed | No outcome recorded |
| Phase 1/2 | NCT02124772 | Jan 2015 → Dec 2020 | cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/2 | NCT02230553 | Oct 2014 → Jul 2019 | colorectal cancer | The Netherlands Cancer Institute | Completed | No outcome recorded |
| Phase 1/2 | NCT02257424 | Oct 2014 → Oct 2021 | melanoma | Abramson Cancer Center at Penn Medicine | Completed | No outcome recorded |
| Phase 1/2 | NCT02143050 | Sep 2014 → Nov 2017 | melanoma | University of Louisville | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT02130466 | May 2014 → Jul 2021 | cancer, melanoma | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1/2 | NCT02079740 | Mar 2014 → Dec 2022 overdue | metastatic malignant neoplasm, refractory malignant neoplasm | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT01989585 | Mar 2014 → Dec 2027 expected | cutaneous melanoma, metastatic melanoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT01902173 | Oct 2013 → May 2018 | cutaneous melanoma, hematopoietic and lymphoid cell neoplasm, metastatic malignant neoplasm, metastatic melanoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1/2 | NCT01750918 | Dec 2012 → Jun 2020 | cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2118 trials | ||||||
| Phase 2 | NCT07477457 | Mar 2026 → Mar 2028 expected | metastatic neoplasm, osteosarcoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07110246 | Nov 2025 → Mar 2032 expected | low grade glioma | University of California, San Francisco | Recruiting | No outcome recorded |
| Phase 2 | NCT07549646 | Aug 2025 → Aug 2029 expected | vascular malformation | Children's Hospital of Philadelphia | Active not recruiting | No outcome recorded |
| Phase 2 | NCT07022834 | Jun 2025 → Jun 2028 expected | Langerhans cell histiocytosis | West China Second University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06933394 | May 2025 → May 2031 expected | neuroblastoma | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Recruiting | No outcome recorded |
| Phase 2 | NCT06119789 | Mar 2025 → Nov 2033 expected | high grade malignant neoplasm | Oslo University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06967155 | Mar 2025 → Nov 2027 expected | neoplasm | Blokhin's Russian Cancer Research Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06563999 | Nov 2024 → Nov 2027 expected | lung carcinoma | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 2 | NCT06739395 | Nov 2024 → Dec 2026 expected | cancer | Tianjin Medical University Second Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06555237 | Aug 2024 → Aug 2026 overdue | Noonan syndrome | Medical University of Warsaw | Recruiting | No outcome recorded |
| Show all 118 trials opens the full record — a long page | ||||||
| Phase 2/34 trials | ||||||
| Phase 2/3 | NCT07440290 | Feb 2026 → Oct 2029 expected | Erdheim-Chester disease, Langerhans cell histiocytosis, colorectal neoplasm, digestive system cancer +9 | Cancer Research UK | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT06819605 | Mar 2025 → Oct 2028 expected | ameloblastoma | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT05722886 | Mar 2023 → Oct 2029 expected | cancer, hematopoietic and lymphoid cell neoplasm | Cancer Research UK | Recruiting | No outcome recorded |
| Phase 2/3 | NCT02101788 | Apr 2014 → Apr 2019 | borderline ovarian serous tumor, micropapillary serous carcinoma, ovarian serous adenocarcinoma, primary peritoneal serous adenocarcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 38 trials | ||||||
| Phase 3 | NCT06346067 | Apr 2024 → Apr 2028 expected | melanoma | Erasca, Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04940052 | Nov 2021 → Jan 2025 overdue | differentiated thyroid carcinoma | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03784014 | Oct 2019 → Dec 2023 | soft tissue sarcoma | French National Institute of Health and Medical Research | Completed | No outcome recorded |
| Phase 3 | NCT03551626 | Aug 2018 → Oct 2020 | melanoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01682083 | Jan 2013 → Jun 2017 | melanoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01597908 | Jun 2012 → Apr 2014 | melanoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01584648 | May 2012 → Aug 2013 | melanoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01245062 | Nov 2010 → Oct 2011 | melanoma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT07010393 | Jul 2025 → Dec 2027 expected | thyroid tumor | Fujian Medical University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06195228 | Jan 2020 → Dec 2026 expected | — | Fudan University | Recruiting | No outcome recorded |
| Phase 4 | NCT03975829 | Nov 2019 → Nov 2026 expected | Lhermitte-Duclos disease, anaplastic astrocytoma, anaplastic ganglioglioma, anaplastic oligodendroglioma +16 | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 4 | NCT03340506 | Jan 2018 → Dec 2032 expected | glioma, melanoma, non-small cell lung carcinoma | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT04801966 | Sep 2021 → Dec 2022 | cancer | Peter MacCallum Cancer Centre, Australia | Terminated | No outcome recorded |
| — | NCT05063058 | Jan 2016 → Nov 2019 | melanoma | Charite University, Berlin, Germany | Completed | No outcome recorded |
| — | NCT02551718 | Sep 2015 → Jun 2020 | acute leukemia of ambiguous lineage, acute lymphoblastic leukemia | University of Washington | Completed | No outcome recorded |
| Phase not stated4 trials | ||||||
| — | NCT03386071 | — | castration-resistant prostate carcinoma | Jonsson Comprehensive Cancer Center | No longer available | No outcome recorded |
| — | NCT02416232 | — | cutaneous melanoma | GlaxoSmithKline | No longer available | No outcome recorded |
| — | NCT04489433 | — | melanoma | Novartis Pharmaceuticals | No longer available | No outcome recorded |
| — | NCT04544202 | — | melanoma | Novartis Pharmaceuticals | No longer available | No outcome recorded |
Also used as a comparator or background therapy in 13 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT04903119 Background | Jun 2022 → Jul 2028 expected | metastatic melanoma | Rina Plattner | Recruiting | No outcome recorded |
| Phase 1 | NCT03026517 Background | Jan 2017 → Jan 2025 | melanoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT02110355 Background | Dec 2014 → Dec 2018 | cancer, melanoma | Kartos Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01231594 Background | Nov 2010 → Apr 2018 | cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02872259 Comparator | Feb 2017 → May 2024 | melanoma | Haukeland University Hospital | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT05370807 Background | Oct 2022 → Dec 2024 | metastatic melanoma | University Hospital Brussels | Unknown | No outcome recorded |
| Phase 2 | NCT04527549 Background | Jun 2021 → Jan 2024 | cutaneous melanoma | ECOG-ACRIN Cancer Research Group | Terminated | No outcome recorded |
| Phase 2 | NCT04238624 Background | Jan 2020 → Jun 2027 expected | thyroid gland undifferentiated (anaplastic) carcinoma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT01990196 Comparator | Sep 2014 → Sep 2024 overdue | prostate cancer | Jonsson Comprehensive Cancer Center | Active not recruiting | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT06475989 Comparator | Aug 2024 → Sep 2030 expected | differentiated thyroid carcinoma | ECOG-ACRIN Cancer Research Group | Recruiting | No outcome recorded |
| Phase 3 | NCT02967692 Background | Feb 2017 → Aug 2020 | melanoma | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT03979651 Background | Oct 2019 → Jan 2023 | metastatic melanoma | Hospices Civils de Lyon | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT04507919 Background | — | small cell lung carcinoma | Novartis Pharmaceuticals | No longer available | No outcome recorded |
Press releases naming this drug 27 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-03-17 | Novartis Pharmaceuticals | Novartis Tafinlar + Mekinist approved by FDA for pediatric patients with BRAF V600E low-grade glioma, the most common pediatric brain cancer novartis.com ↗ |
| 2022-06-23 | Novartis Pharmaceuticals | Novartis Tafinlar + Mekinist receives FDA approval for first tumor-agnostic indication for BRAF V600E solid tumors novartis.com ↗ |
| 2022-06-06 | Novartis Pharmaceuticals | Novartis Tafinlar® (dabrafenib) + Mekinist® (trametinib) demonstrates unprecedented efficacy in pediatric patients with BRAF V600 low-grade gliomas in Phase II/III study novartis.com ↗ |
| 2020-09-19 | Novartis Pharmaceuticals | Novartis reports late-breaking data from Phase III COMBI-i trial of spartalizumab (PDR001) with Tafinlar® and Mekinist® in advanced melanoma novartis.com ↗ |
| 2020-09-16 | Novartis Pharmaceuticals | Novartis Tafinlar® + Mekinist® demonstrates long-term, relapse-free survival benefit for high-risk, stage III melanoma patients in study published in NEJM novartis.com ↗ |
| 2020-08-22 | Novartis Pharmaceuticals | Novartis provides update on Phase III study evaluating investigational spartalizumab (PDR001) in combination with Tafinlar® + Mekinist® in advanced melanoma novartis.com ↗ |
| 2020-05-29 | Novartis Pharmaceuticals | Novartis announces long-term, relapse-free survival benefit for high-risk, stage III melanoma patients treated with Tafinlar® + Mekinist® following surgery novartis.com ↗ |
| 2019-06-04 | Novartis Pharmaceuticals | Long-term survival benefit shown for metastatic melanoma patients treated with Novartis Tafinlar® + Mekinist® novartis.com ↗ |
| 2018-10-22 | Novartis Pharmaceuticals | Novartis COMBI-AD study of Tafinlar® + Mekinist® continues to demonstrate relapse free survival benefit in patients with BRAF V600-mutant stage III melanoma novartis.com ↗ |
| 2018-08-29 | Novartis Pharmaceuticals | European Commission approves Novartis combination therapy Tafinlar® + Mekinist® for adjuvant treatment of BRAF V600 mutation-positive melanoma novartis.com ↗ |
| 2018-07-27 | Novartis Pharmaceuticals | Novartis combination Tafinlar® + Mekinist® receives positive CHMP opinion for adjuvant treatment of BRAF V600 mutation-positive melanoma novartis.com ↗ |
| 2018-04-30 | Novartis Pharmaceuticals | Novartis receives FDA approval of Tafinlar® + Mekinist® for adjuvant treatment of BRAF V600-mutant melanoma novartis.com ↗ |
| 2017-12-22 | Novartis Pharmaceuticals | Novartis' combination therapy Tafinlar® + Mekinist® granted FDA Priority Review for the adjuvant treatment of stage III BRAF V600 mutation-positive melanoma novartis.com ↗ |
| 2017-10-23 | Novartis Pharmaceuticals | Novartis combination adjuvant therapy Tafinlar® + Mekinist® receives FDA Breakthrough Therapy Designation for stage III BRAF V600 mutation-positive melanoma patients novartis.com ↗ |
| 2017-09-11 | Novartis Pharmaceuticals | Novartis Phase III study demonstrates adjuvant Tafinlar® + Mekinist® reduced the risk of disease recurrence by 53% in patients with resected BRAF V600 mutation-positive melanoma novartis.com ↗ |
| 2017-06-22 | Novartis Pharmaceuticals | Novartis combination targeted therapy Tafinlar® + Mekinist® receives FDA approval for BRAF V600E mutant metastatic non-small cell lung cancer (NSCLC) novartis.com ↗ |
| 2017-06-04 | Novartis Pharmaceuticals | Novartis landmark study of Tafinlar® + Mekinist® demonstrates durable survival benefit at five years in patients with BRAF mutation-positive metastatic melanoma novartis.com ↗ |
| 2017-04-03 | Novartis Pharmaceuticals | Novartis drug combination Tafinlar® + Mekinist® receives EU approval for BRAF V600-positive advanced non-small cell lung cancer (NSCLC) novartis.com ↗ |
| 2017-02-24 | Novartis Pharmaceuticals | Novartis receives positive CHMP opinion for Tafinlar® + Mekinist® in BRAF-positive non-small cell lung cancer (NSCLC) patients novartis.com ↗ |
| 2016-10-08 | Novartis Pharmaceuticals | Novartis' Tafinlar® (dabrafenib) + Mekinist® (trametinib) demonstrate superior overall survival benefit in advanced melanoma patients at three-year follow up novartis.com ↗ |
| 2016-06-06 | Novartis Pharmaceuticals | Novartis pivotal data for Tafinlar® + Mekinist® demonstrated a 63 percent overall response rate in treating rare form of lung cancer novartis.com ↗ |
| 2016-06-06 | Novartis Pharmaceuticals | Novartis combination therapy Tafinlar® + Mekinist® demonstrates overall survival benefit at three-year follow-up in patients with advanced melanoma novartis.com ↗ |
| 2015-09-28 | Novartis Pharmaceuticals | Patients with aggressive form of melanoma lived for more than two years on average when taking Novartis therapies Tafinlar® + Mekinist® novartis.com ↗ |
| 2015-09-01 | Novartis Pharmaceuticals | Novartis receives EU approval for Tafinlar® and Mekinist®, first combination approved for patients with aggressive form of melanoma novartis.com ↗ |
| 2015-07-24 | Novartis Pharmaceuticals | Novartis combination therapy Tafinlar® and Mekinist® achieves important EU and US regulatory milestones novartis.com ↗ |
| 2015-06-01 | Novartis Pharmaceuticals | Novartis presents new data at ASCO for Zykadia® and combination of Tafinlar® and Mekinist® in certain NSCLC patients with unmet needs novartis.com ↗ |
| 2015-05-31 | Novartis Pharmaceuticals | Combination of Novartis drugs Tafinlar® and Mekinist® shows significant survival benefit in patients with metastatic melanoma novartis.com ↗ |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 269 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | trametinib | “Managed Access Program Cohort Treatment Plan CTMT212X2002I to Provide Access to Trametinib and Dabrafenib Combination Therapy for Patients With BRAF V600 Mutation-positive...” NCT04507919 ↗243“we randomly assigned 322 patients who had metastatic melanoma with a V600E or V600K BRAF mutation to receive either trametinib, an oral selective MEK inhibitor, or chemotherapy...” PMID 22663011 ↗ Jun 2012 “Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and...” NCT01553851 ↗ “Phase II study of the MEK1/MEK2 inhibitor Trametinib in patients with metastatic BRAF-mutant cutaneous melanoma previously treated with or without a BRAF inhibitor.” PMID 23248257 ↗ Dec 2012 “A phase IB trial of the oral MEK inhibitor trametinib (GSK1120212) in combination with everolimus in patients with advanced solid tumors.” PMID 25344362 ↗ Oct 2014 “For example, Trametinib is used as follows: Trametinib will be administered daily from Cycle 5 until the end of induction chemotherapy.” NCT06933394 ↗ “A Study to Determine the Relative Bioavailability of the MEK Inhibitor, Trametinib, in Subjects With Solid Tumor Malignancies” NCT01725100 ↗ “Approved BRAF-/MEK- inhibitor combinations include dabrafenib/trametinib and encorafenib/binimetinib.” NCT05370807 ↗ “Dabrafenib 150 mg twice a day combined with Trametinib 2 mg once a day for 4 weeks” NCT04644432 ↗ “A randomized phase II study of the MEK1/MEK2 inhibitor trametinib (GSK1120212)” PMID 25722381 ↗ Feb 2015 “A phase I/Ib study of trametinib (GSK1120212) alone and in combination with” PMID 26259955 ↗ Aug 2015 “MEK Inhibitors (Trametinib 2 mg/d, Selumetinib 75 mg 2/d)” NCT05063058 ↗ “Topotecan HCl Trametinib Tretinoin” NCT02551718 ↗ “Trametinib 2 mg once daily orally” NCT06229340 ↗ “Dabrafenib + trametinib” NCT04817956 ↗ “Drug: Trametinib” NCT03754179 ↗ |
| Known as | GSK1120212 | “This is a multi-cohort, open label, Phase II study with Dabrafenib (GSK2118436) and Trametinib (GSK1120212) combination therapy in subject with BRAF mutation-positive melanoma...” NCT02039947 ↗30“The purpose of this study was to determine the response rate (RR) for the selective, allosteric MEK1/MEK2 inhibitor trametinib (GSK1120212), in patients with metastatic...” PMID 23248257 ↗ Dec 2012 “This was a two-arm, open-label, randomized, Phase III study comparing dabrafenib (GSK2118436) and trametinib (GSK1120212) combination therapy with vemurafenib.” NCT01597908 ↗ “Each tablet contains GSK1120212B equivalent to 2 mg of GSK1120212 as drug substance.” NCT01725100 ↗ “A phase I/Ib study of trametinib (GSK1120212) alone and in combination with” PMID 26259955 ↗ Aug 2015 “Trametinib (GSK1120212)” NCT01941927 ↗ “Trametinib (GSK1120212)” NCT01192165 ↗ |
| Known as | GSK1120212B | “Each tablet will contain GSK1120212B equivalent to 0.5 mg of Trametinib.” NCT02292732 ↗ |
| Known as | MEK Inhibitor Trametinib GSK1120212 | “MEK Inhibitor Trametinib GSK1120212” NCT01726738 ↗ |
| Known as | Mekinist | “On March 16, 2023, the FDA approved dabrafenib in combination with trametinib (Tafinlar, Mekinist; Novartis Pharmaceuticals Corporation) for the treatment of pediatric patients...” PMID 37610803 ↗ Jan 20245“The main purpose of this study is to determine the risks and benefits of ceritinib (ZYKADIA) given in combination with trametinib (MEKINIST) in patients who have progressed on...” NCT03501368 ↗ “Mekinist© (Trametinib) taken orally each day with a 18-course schedule of 4 weeks each.” NCT05180825 ↗ “Study drugs are Dabrafenib (Tafinlar) and trametinib (Mekinist)” NCT05525273 ↗ “Trametinib 2 MG [Mekinist]” NCT04619316 ↗ “Trametinib (Mekinist)” NCT03149029 ↗ |
| Known as | MEKINISTR | “Trametinib (MEKINISTR) is an orally available MEK inhibitor that is currently approved in combination with the BRAF inhibitor dabrafenib (TAFINLARR) to treat BRAF mutated...” NCT03979651 ↗ |
| Known as | TMT212 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02900664 ↗ |
| Known as | Trametinib Dimethyl Sulfoxide | “Drug: Trametinib Dimethyl Sulfoxide” NCT03794297 ↗4“Drug: Trametinib Dimethyl Sulfoxide” NCT04439357 ↗ “Drug: Trametinib Dimethyl Sulfoxide” NCT04557956 ↗ “Drug: Trametinib Dimethyl Sulfoxide” NCT02196181 ↗ “Drug: Trametinib Dimethyl Sulfoxide” NCT04439279 ↗ |
| Action | Inhibit | “the MEK Inhibitor GSK1120212” NCT00687622 ↗ |
| Modality | Small molecule | “Investigational small molecule targeted therapy (MEK1/2 inhibitor)” NCT01192165 ↗ |
| Route | Oral | “orally administered GSK1120212” NCT00687622 ↗ |
| Target | MEK1 | “Trametinib: Therapeutic class Protein kinase inhibitor of MEK1 and MEK2 activation and kinase activity.” NCT03714958 ↗ |
| Target | MEK2 | “Trametinib: Therapeutic class Protein kinase inhibitor of MEK1 and MEK2 activation and kinase activity.” NCT03714958 ↗ |