Drugs / Dabrafenib
Dabrafenib
also known as
GSK2118436 · Dabrafenib Mesylate · Tafinlar · GSK2118436B · BRAF Inhibitor Dabrafenib GSK2118436 · Dabrafenib mesilate · Finlee · GSK-2118436 METHANESULFONATE SALT · +5 more
Small molecule targets BRAF via inhibition
Regulatory milestones approvals, filings & regulatory actions · 14 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (12) | US (FDA) | TAFINLAR | — | 2014-01-09 – 2025-03-07 | fda.gov ↗ |
| Approved | EU (EMA) | Tafinlar | — | 2013-08-26 | europa.eu ↗ |
| Approved | US (FDA) | TAFINLAR | — | 2013-05-29 | fda.gov ↗ |
Trials 146 · started per year
today
US approved 2013
EU approved 2013
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 134 trials | ||||||
| Phase 1 | NCT05388877 | Oct 2022 → Nov 2024 | cutaneous melanoma, metastatic malignant neoplasm in the brain, metastatic melanoma | Mayo Clinic | Terminated | No outcome recorded |
| Phase 1 | NCT04903119 | Jun 2022 → Jul 2028 expected | metastatic melanoma | Rina Plattner | 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 | NCT04418167 | Jun 2020 → Dec 2025 | cancer | JS InnoPharm, LLC | Suspended | 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 | NCT03272464 | May → Jul 2019 | melanoma | Massachusetts General Hospital | Terminated | No outcome recorded |
| Phase 1 | NCT03332589 | Jul 2018 → Apr 2021 | melanoma, metastatic malignant neoplasm in the brain | Spirita Oncology, LLC | 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 | NCT02873650 | Dec 2016 → Oct 2018 | — | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 1 | NCT02852239 | Dec 2016 → Sep 2019 | impaired renal function disease | 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 | NCT02357732 | Aug 2015 | metastatic melanoma | University of Pittsburgh | Withdrawn | No outcome recorded |
| Phase 1 | NCT02082665 | Feb 2015 → Jul 2016 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT02110355 | Dec 2014 → Dec 2018 | cancer, melanoma | Kartos Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02200562 | Dec 2014 → Jan 2017 | melanoma | University of Utah | Terminated | 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 | NCT02027961 | Dec 2013 → Apr 2018 | melanoma | MedImmune LLC | Completed | No outcome recorded |
| Phase 1 | NCT01954043 | Dec 2013 → Feb 2016 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01947023 | Sep 2013 → Apr 2026 overdue | thyroid gland carcinoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1 | NCT01940809 | Aug 2013 → Jul 2020 | cutaneous melanoma, metastatic melanoma | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 1 | NCT01907802 | Aug 2013 → Dec 2015 | kidney failure, liver disorder, neoplasm | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 1 | NCT01767454 | Feb 2013 → Sep 2015 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01738451 | Jan 2013 → Nov 2014 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01713972 | Nov 2012 → Jul 2016 | cancer of unknown primary site | Manisha Shah | Completed | No outcome recorded |
| Phase 1 | NCT01340846 | Sep → Nov 2012 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01582997 | May 2012 → Aug 2014 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01340833 | Jun → Sep 2011 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01262963 | Jan → Apr 2011 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01231594 | Nov 2010 → Apr 2018 | cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01231568 | Oct 2010 → May 2011 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00880321 | Jun 2009 → Mar 2011 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1/215 trials | ||||||
| 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 | NCT04557956 | Aug 2021 → Oct 2025 overdue | cutaneous melanoma, metastatic melanoma | National Cancer Institute (NCI) | Active not recruiting | 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 | NCT03455764 | Sep 2018 → Sep 2023 | melanoma | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 1/2 | NCT03754179 | Jan 2018 → Dec 2021 | melanoma | University Hospital Brussels | Unknown | No outcome recorded |
| Phase 1/2 | NCT03391050 | Jan → Aug 2018 | melanoma | Aprea Therapeutics | 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 | 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 | 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 | NCT01677741 | May 2013 → Dec 2020 | brain neoplasm | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/2 | NCT01750918 | Dec 2012 → Jun 2020 | cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 275 trials | ||||||
| Phase 2 | NCT07714447 | Nov 2026 → Feb 2029 expected | colorectal cancer | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07506109 | Mar 2026 → Dec 2027 expected | colorectal cancer | Tianjin Medical University Cancer Institute and Hospital | 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 | NCT07022834 | Jun 2025 → Jun 2028 expected | Langerhans cell histiocytosis | West China Second University Hospital | 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 | NCT06978400 | Mar 2025 → Nov 2027 expected | neoplasm | Blokhin's Russian Cancer Research Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06739395 | Nov 2024 → Dec 2026 expected | cancer | Tianjin Medical University Second Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06563999 | Nov 2024 → Nov 2027 expected | lung carcinoma | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 2 | NCT06362694 | Mar 2024 → Mar 2026 | thyroid gland undifferentiated (anaplastic) carcinoma | Saint Petersburg State University, Russia | Unknown | No outcome recorded |
| Phase 2 | NCT06054191 | Feb 2024 → Mar 2025 overdue | non-small cell lung carcinoma | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05525273 | Sep 2023 → Sep 2027 expected | craniopharyngioma | Eva Marie Erfurth, MD, PhD | Recruiting | No outcome recorded |
| Phase 2 | NCT05876806 | Jun 2023 → Mar 2026 | cancer | Se Jun Park | Unknown | No outcome recorded |
| Phase 2 | NCT06079333 | Jan 2023 → Jan 2027 expected | thyroid gland undifferentiated (anaplastic) carcinoma | Leiden University Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06653517 | Jan 2023 → Dec 2026 expected | ameloblastoma | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | Recruiting | No outcome recorded |
| Phase 2 | NCT05182931 | Jul 2022 → Dec 2024 | thyroid cancer | Olivia Newton-John Cancer Research Institute | Unknown | No outcome recorded |
| Phase 2 | NCT05159245 | Dec 2021 → Nov 2026 expected | cancer, hematopoietic and lymphoid cell neoplasm | Helsinki University Central Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04675710 | Jun 2021 → Oct 2026 expected | thyroid gland squamous cell carcinoma, thyroid gland undifferentiated (anaplastic) carcinoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06482086 | Jun 2021 → Dec 2024 overdue | thyroid gland carcinoma | West China Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04817956 | Apr 2021 → Mar 2040 expected | metastatic malignant neoplasm | Oslo University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05299580 | Feb 2021 → Mar 2023 | melanoma | Fondazione Melanoma Onlus | Withdrawn | No outcome recorded |
| Phase 2 | NCT04739566 | Jan 2021 → Dec 2023 | thyroid gland undifferentiated (anaplastic) carcinoma | Saint Petersburg State University, Russia | Withdrawn | No outcome recorded |
| Phase 2 | NCT04554680 | Dec 2020 → Dec 2021 | thyroid cancer | National University Hospital, Singapore | Unknown | No outcome recorded |
| Phase 2 | NCT04544111 | Sep 2020 → Sep 2026 expected | poorly differentiated thyroid gland carcinoma, thyroid gland follicular carcinoma, thyroid gland papillary carcinoma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04452877 | Aug 2020 → Nov 2024 | non-small cell lung carcinoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT04644432 | Mar 2020 → Sep 2022 | renal cell carcinoma | Herlev and Gentofte Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT03919071 | Feb 2020 → Sep 2027 expected | anaplastic astrocytoma, anaplastic ganglioglioma, anaplastic pleomorphic xanthoastrocytoma, glioblastoma +1 | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04310397 | Jan 2020 → Oct 2023 | cutaneous melanoma | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 2 | NCT04116541 | Jan 2020 → Oct 2026 expected | cancer | Centre Leon Berard | Recruiting | No outcome recorded |
| Phase 2 | NCT03972046 | Jun 2019 → Feb 2020 | cutaneous melanoma, metastatic melanoma | TriHealth Inc. | Withdrawn | No outcome recorded |
| Phase 2 | NCT04059224 | Jan 2019 → Jun 2023 | melanoma | University Hospital Brussels | Completed | No outcome recorded |
| Phase 2 | NCT03794297 | Jan 2019 → Feb 2021 | Erdheim-Chester disease | National Cancer Institute (NCI) | Withdrawn | No outcome recorded |
| Phase 2 | NCT03668431 | Oct 2018 → Sep 2022 | colorectal cancer | Massachusetts General Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT02672358 | Sep 2018 → Sep 2019 | non-small cell lung carcinoma | Novartis Pharmaceuticals | Withdrawn | No outcome recorded |
| Phase 2 | NCT03543306 | Jun 2018 → Jun 2020 | lung cancer | Asan Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT03563729 | Jun 2018 → Jun 2024 overdue | melanoma | Inge Marie Svane | Recruiting | No outcome recorded |
| Phase 2 | NCT02974803 | Feb 2018 → Jul 2020 | melanoma, metastatic malignant neoplasm in the brain | Canadian Cancer Trials Group | Terminated | No outcome recorded |
| Phase 2 | NCT04619316 | Feb 2018 → Dec 2024 | thyroid cancer | University Hospital, Essen | Unknown | No outcome recorded |
| Phase 2 | NCT02684058 | Dec 2017 → Aug 2021 | Lhermitte-Duclos disease, anaplastic astrocytoma, anaplastic ganglioglioma, anaplastic oligodendroglioma +15 | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT03244956 | Dec 2017 → May 2022 | cancer, familial, with in vitro Radioresistance | Gustave Roussy, Cancer Campus, Grand Paris | Completed | No outcome recorded |
| Phase 2 | NCT03149029 | Nov 2017 → Dec 2021 overdue | metastatic melanoma | Massachusetts General Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02858921 | Nov 2017 → Jan 2022 | melanoma | Melanoma Institute Australia | Unknown | No outcome recorded |
| Phase 2 | NCT03352947 | Nov 2017 → Mar 2020 | melanoma | Cambridge University Hospitals NHS Foundation Trust | Completed | No outcome recorded |
| Phase 2 | NCT02367859 | Jul 2017 → Nov 2018 | ameloblastoma | Stanford University | Completed | No outcome recorded |
| Phase 2 | NCT03239015 | Jan 2017 → Jun 2023 | refractory malignant neoplasm | Baodong Qin | Unknown | No outcome recorded |
| Phase 2 | NCT02910700 | Dec 2016 → Dec 2027 expected | cutaneous melanoma, metastatic malignant neoplasm in the brain, metastatic melanoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02925234 | Aug 2016 → Sep 2027 expected | cancer | The Netherlands Cancer Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT02693535 | Mar 2016 → Dec 2027 expected | non-Hodgkin lymphoma, plasma cell myeloma | American Society of Clinical Oncology | Recruiting | No outcome recorded |
| Phase 2 | NCT04439292 | Jan 2016 → Nov 2023 overdue | adult lymphoma, plasma cell myeloma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02625337 | Jan 2016 → Jun 2018 | metastatic melanoma | The Netherlands Cancer Institute | Unknown | No outcome recorded |
| Phase 2 | NCT02410863 | Nov 2015 → Aug 2018 | melanoma | Prof. Dr. med. Dirk Schadendorf | Terminated | No outcome recorded |
| Phase 2 | NCT02465060 | Aug 2015 → Dec 2026 expected | breast carcinoma, carcinoma of esophagus, cervical carcinoma, colon carcinoma +17 | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02281760 | Nov 2014 → Aug 2018 | — | National Human Genome Research Institute (NHGRI) | Completed | No outcome recorded |
| Phase 2 | NCT02231775 | Oct 2014 → Apr 2027 expected | cutaneous melanoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT01972347 | Oct 2014 → May 2017 | melanoma | Melanoma Institute Australia | Completed | No outcome recorded |
| Phase 2 | NCT02296996 | Oct 2014 → Dec 2017 | melanoma | University Hospital Brussels | Completed | No outcome recorded |
| Phase 2 | NCT02196181 | Sep 2014 → Mar 2027 expected | cutaneous melanoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02142036 | May 2014 → Aug 2018 | metastatic malignant neoplasm | Oslo University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT01978236 | Apr 2014 → Apr 2017 | metastatic melanoma | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 2 | NCT02083354 | Mar 2014 → Feb 2018 | cancer, melanoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02034110 | Mar 2014 → Dec 2021 | cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02039947 | Feb 2014 → May 2017 | metastatic melanoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02052193 | Jan → Dec 2014 | metastatic melanoma | University Hospital Tuebingen | Terminated | No outcome recorded |
| Phase 2 | NCT02314143 | Nov 2013 → Jan 2017 | melanoma | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 2 | NCT01928940 | Aug 2013 → Sep 2014 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01726738 | Apr 2013 → Nov 2017 | melanoma | UNC Lineberger Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT01721603 | Apr 2013 → Jan 2016 | — | University of California, San Francisco | Terminated | No outcome recorded |
| Phase 2 | NCT01701037 | Jan 2013 → Feb 2015 | melanoma | Vanderbilt-Ingram Cancer Center | Terminated | No outcome recorded |
| Phase 2 | NCT01723202 | Nov 2012 → Apr 2022 | poorly differentiated thyroid gland carcinoma, thyroid gland follicular carcinoma, thyroid gland papillary carcinoma | Bhavana Konda | Completed | No outcome recorded |
| Phase 2 | NCT01682213 | Sep 2012 → May 2019 | melanoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT01619774 | Sep 2012 → Aug 2015 | melanoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT01336634 | Aug 2011 → Oct 2015 | cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01266967 | Feb → Nov 2011 | metastatic melanoma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01153763 | Aug 2010 → Jul 2011 | melanoma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01072175 | Mar 2010 → May 2012 | cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2/33 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 39 trials | ||||||
| Phase 3 | NCT06264778 | Mar 2024 → Nov 2025 | ameloblastoma | Shandong University | Unknown | 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 | NCT02224781 | Sep 2015 → Sep 2023 overdue | cutaneous melanoma, metastatic melanoma | National Cancer Institute (NCI) | Active not recruiting | 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 | NCT01227889 | Dec 2010 → Dec 2011 | cancer | 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 applicable4 trials | ||||||
| — | NCT05963087 | Aug 2023 → Feb 2025 | colorectal cancer | Zhejiang Cancer Hospital | Unknown | No outcome recorded |
| — | NCT04801966 | Sep 2021 → Dec 2022 | cancer | Peter MacCallum Cancer Centre, Australia | Terminated | No outcome recorded |
| — | NCT02551718 | Sep 2015 → Jun 2020 | acute leukemia of ambiguous lineage, acute lymphoblastic leukemia | University of Washington | Completed | No outcome recorded |
| — | NCT01534897 | Jul 2012 → Mar 2014 | thyroid gland papillary carcinoma | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase not stated2 trials | ||||||
| — | 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 10 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03026517 Background | Jan 2017 → Jan 2025 | melanoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT05585320 Background | Oct 2022 → Jun 2026 overdue | cutaneous melanoma, non-small cell lung carcinoma, pancreatic adenocarcinoma | Immuneering Corporation | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT02872259 Comparator | Feb 2017 → May 2024 | melanoma | Haukeland University Hospital | Completed | No outcome recorded |
| Phase 23 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 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 stated2 trials | ||||||
| — | NCT02416232 Background | — | cutaneous melanoma | GlaxoSmithKline | No longer available | No outcome recorded |
| — | 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 18 cited values
Every value below carries the sentence it was read from. 158 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | dabrafenib | “Dabrafenib is a small-molecule inhibitor of BRAF kinase activity that is currently being developed for the treatment of BRAF V600 mutation-positive melanoma.” PMID 23608920 ↗ Apr 2013141“BRAF inhibitors (encorafenib, vemurafenib, dabrafenib, etc.) are selected by researchers from the available drugs based on their accessibility” NCT07714447 ↗ “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 ↗ “Dabrafenib 150 mg twice daily and trametinib 2 mg once daily” NCT03543306 ↗ “Cytarabine HCl Dabrafenib Dasatinib” NCT02551718 ↗ “Dabrafenib + trametinib” NCT04817956 ↗ “Drug: Dabrafenib” NCT03754179 ↗ “Dabrafenib” NCT02142036 ↗ |
| Known as | BRAF Inhibitor Dabrafenib GSK2118436 | “BRAF Inhibitor Dabrafenib GSK2118436” NCT01726738 ↗ |
| Known as | Dabrafenib mesilate | ChEMBL registry synonym — accepted as the source's own label CHEMBL2028663 ↗ |
| Known as | Dabrafenib Mesylate | “Generic name: Dabrafenib mesylate capsules” NCT06264778 ↗4“Drug: Dabrafenib Mesylate” NCT02196181 ↗ “Drug: Dabrafenib Mesylate” NCT04557956 ↗ “Drug: Dabrafenib Mesylate” NCT03794297 ↗ |
| Known as | Finlee | ChEMBL registry synonym — accepted as the source's own label CHEMBL2028663 ↗ |
| Known as | GSK-2118436 METHANESULFONATE SALT | ChEMBL registry synonym — accepted as the source's own label CHEMBL2028663 ↗ |
| Known as | GSK-2118436A | ChEMBL registry synonym — accepted as the source's own label CHEMBL2028663 ↗ |
| Known as | GSK-2118436B MESYLATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL2028663 ↗ |
| Known as | GSK-2118436B METHANESULFONATE SALT | ChEMBL registry synonym — accepted as the source's own label CHEMBL2028663 ↗ |
| Known as | GSK2118436 | “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 ↗17“This was a two-arm, open-label, randomized, Phase III study comparing dabrafenib (GSK2118436) and trametinib (GSK1120212) combination therapy with vemurafenib.” NCT01597908 ↗ “Adjuvant Dabrafenib (GSK2118436) in Patients With Surgically Resected AJCC Stage IIIC Melanoma Characterized by a BRAFV600E/K Mutation” NCT01682213 ↗ “An Open-label Phase 1 Study to Evaluate the Effects of Dabrafenib (GSK2118436) on the Single Dose Pharmacokinetics” NCT02082665 ↗ “Repeat Dose Pharmacokinetics of Dabrafenib (GSK2118436)” NCT01954043 ↗ |
| Known as | GSK2118436B | “A Phase 1 and Pharmacokinetic Study of Dabrafenib (GSK2118436B) in Patients With BRAFV600X Mutations and Renal or Hepatic Dysfunction” NCT01907802 ↗1“Dabrafenib mesylate (GSK2118436B) is a potent and selective BRAF kinase inhibitor.” NCT02281760 ↗ |
| Known as | METHANE SULFONATE SALT | ChEMBL registry synonym — accepted as the source's own label CHEMBL2028663 ↗ |
| Known as | mFOLFOX6 + dabrafenib and cetuximab or panitumumab in the first line of therapy | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06978400 ↗ |
| Known as | Tafinlar | “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 20243“Trametinib 2 MG [Mekinist] and Dabrafenib 75 MG (2-0-2) [Tafinlar]” NCT04619316 ↗ “Study drugs are Dabrafenib (Tafinlar) and trametinib (Mekinist)” NCT05525273 ↗ “Dabrafenib (Tafinlar)” NCT03149029 ↗ |
| Action | Inhibit | “BRAF inhibitor” NCT00880321 ↗ |
| Modality | Small molecule | “Dabrafenib is a small-molecule inhibitor of BRAF kinase activity” PMID 23608920 ↗ Apr 2013 |
| Route | Oral | “orally administered GSK2118436” NCT00880321 ↗ |
| Target | BRAF | “BRAF inhibitor” NCT00880321 ↗ |