Drugs / Vemurafenib
Vemurafenib
also known as
PLX4032 · RO5185426 · RG7204 · Zelboraf · VEM · RO5185426, Zelboraf · Vemurafenib = Zelboraf (commercial name) · Vemurafenib branded as Zelboraf · +5 more
Small molecule targets BRAF via inhibition
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (4) | US (FDA) | ZELBORAF | — | 2014-03-19 – 2017-11-06 | fda.gov ↗ |
| Approved | EU (EMA) | Zelboraf | — | 2012-02-17 | europa.eu ↗ |
| Approved | US (FDA) | ZELBORAF | — | 2011-08-17 | fda.gov ↗ |
Trials 146 · started per year
today
US approved 2011
EU approved 2012
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 03 trials | ||||||
| Phase 0 | NCT05238831 | Jan 2023 → May 2026 | female breast carcinoma, ovarian carcinoma, pancreatic ductal adenocarcinoma, pancreatic large cell neuroendocrine carcinoma +2 | OHSU Knight Cancer Institute | Withdrawn | No outcome recorded |
| Phase 0 | NCT02145143 | May 2014 → Nov 2024 | thyroid gland carcinoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 0 | NCT01748149 | Apr 2014 → Dec 2018 | glioma | University of California, San Francisco | Completed | No outcome recorded |
| Phase 145 trials | ||||||
| Phase 1 | NCT05019534 | Aug 2021 → Aug 2022 | — | West China Hospital | Unknown | No outcome recorded |
| Phase 1 | NCT04462471 | Jun 2020 → Sep 2023 | thyroid gland follicular carcinoma, thyroid gland papillary carcinoma | Memorial Sloan Kettering Cancer Center | Completed | 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 | NCT03781219 | Jul 2018 → Dec 2023 | neoplasm | Shanghai Kechow Pharma, Inc. | Unknown | No outcome recorded |
| Phase 1 | NCT01843738 | Jun 2017 → Aug 2022 | melanoma | University of Utah | Withdrawn | No outcome recorded |
| Phase 1 | NCT02721459 | Sep 2016 → Oct 2019 overdue | melanoma, skin cancer | H. Lee Moffitt Cancer Center and Research Institute | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02818023 | Jul 2016 → Jun 2019 | melanoma | Yana Najjar | Terminated | No outcome recorded |
| Phase 1 | NCT02608034 | May 2016 → Sep 2018 | metastatic melanoma | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02441465 | Aug 2015 → Aug 2016 | melanoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT02456701 | Jun 2015 → Oct 2016 | thyroid cancer | Celldex Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT02068079 | Apr 2014 → Nov 2015 | melanoma | Duke University | Withdrawn | No outcome recorded |
| Phase 1 | NCT01974258 | Feb → Jul 2014 | neoplasm | Hoffmann-La Roche | Withdrawn | No outcome recorded |
| Phase 1 | NCT01826448 | Nov 2013 → Sep 2014 | melanoma | Daiichi Sankyo | Terminated | No outcome recorded |
| Phase 1 | NCT01876641 | Oct 2013 → Jun 2018 | metastatic melanoma | Mohammed M Milhem | Terminated | No outcome recorded |
| Phase 1 | NCT01943422 | Oct 2013 → Nov 2016 | melanoma | John Kirkwood | Completed | No outcome recorded |
| Phase 1 | NCT01765556 | Oct 2013 | melanoma | Hoffmann-La Roche | Withdrawn | No outcome recorded |
| Phase 1 | NCT01844674 | Sep 2013 → Aug 2014 | melanoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01849666 | Sep 2013 → Apr 2014 | melanoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01767623 | Aug 2013 → Apr 2017 | neoplasm | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01910181 | Aug → Oct 2013 | melanoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01841463 | Aug 2013 → Mar 2015 | melanoma | Piramal Enterprises Limited | Suspended | No outcome recorded |
| Phase 1 | NCT01851824 | Aug 2013 → Jun 2014 | melanoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01603212 | Jul 2013 → Jul 2017 | melanoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT01765543 | Jul 2013 → Nov 2015 | melanoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01765569 | Jul 2013 → Jun 2014 | melanoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01897116 | Jun 2013 → Jul 2016 | melanoma | Abramson Cancer Center at Penn Medicine | Completed | No outcome recorded |
| Phase 1 | NCT01835184 | May 2013 → Sep 2014 | melanoma | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 1 | NCT01787500 | Feb 2013 → Jan 2022 | colorectal cancer, metastatic malignant neoplasm | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT01519323 | Jan 2013 → Dec 2015 | melanoma | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 1 | NCT01791309 | Jan 2013 → Mar 2015 | colorectal cancer | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT01596140 | Dec 2012 → Jun 2020 | cancer | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT01656642 | Aug 2012 → Mar 2020 | melanoma | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01673737 | Aug 2012 → Feb 2015 | cancer | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT01636622 | Jul 2012 → Apr 2020 | high grade malignant neoplasm | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT01611675 | Jul 2012 → Jan 2014 | melanoma | Massachusetts General Hospital | Terminated | No outcome recorded |
| Phase 1 | NCT01585415 | Apr 2012 → Jul 2016 | melanoma, metastatic malignant neoplasm | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 1 | NCT01531361 | Feb 2012 → Jan 2021 | metastatic malignant neoplasm | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT01400451 | Nov 2011 → Apr 2013 | melanoma | Bristol-Myers Squibb | Terminated | No outcome recorded |
| Phase 1 | NCT01271803 | Feb 2011 → Oct 2013 | melanoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01264380 | Jan 2011 → May 2013 | melanoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01164891 | Jul 2010 → Dec 2012 | melanoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01107418 | May 2010 → Feb 2013 | melanoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01001299 | Nov 2009 → Feb 2012 | melanoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT00405587 | Nov 2006 → Jul 2015 | colorectal carcinoma, melanoma | Plexxikon | Completed | No outcome recorded |
| Phase 1 | NCT02145910 | ? → Jun 2019 | melanoma, metastatic malignant neoplasm in the brain | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Withdrawn | No outcome recorded |
| Phase 1/29 trials | ||||||
| Phase 1/2 | NCT04790448 | Jul 2020 → Dec 2021 | colorectal cancer | Sun Yat-sen University | Completed | No outcome recorded |
| Phase 1/2 | NCT03101254 | Jun 2017 → Oct 2020 | melanoma | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 1/2 | NCT03013491 | Jan 2017 → Oct 2020 | cancer, lymphoma | CytomX Therapeutics | Terminated | No outcome recorded |
| Phase 1/2 | NCT02354690 | Nov 2014 → Dec 2018 | metastatic melanoma | Inge Marie Svane | Completed | No outcome recorded |
| Phase 1/2 | NCT02115035 | Jul 2014 → Jul 2017 | plasma cell myeloma | University of Arkansas | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT01959633 | Apr 2014 → Mar 2018 | melanoma | Fondazione Melanoma Onlus | Completed | No outcome recorded |
| Phase 1/2 | NCT01616199 | Aug 2012 → Dec 2014 | — | Cascadian Therapeutics Inc. | Terminated | No outcome recorded |
| Phase 1/2 | NCT01638676 | Jul 2012 → Jun 2025 overdue | melanoma | University of Louisville | Recruiting | No outcome recorded |
| Phase 1/2 | NCT01512251 | Jun 2012 → Dec 2013 | melanoma | University of California, San Francisco | Completed | No outcome recorded |
| Phase 274 trials | ||||||
| Phase 2 | NCT07714447 | Nov 2026 → Feb 2029 expected | colorectal cancer | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06692491 | Jan 2025 → Dec 2027 expected | — | Peking University Shenzhen Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06561360 | Sep 2024 → Sep 2027 expected | hairy cell leukemia | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06603376 | Sep 2024 → Aug 2026 overdue | colorectal carcinoma | Shanghai Changzheng Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06440850 | Jul 2024 → Nov 2026 expected | thyroid gland follicular carcinoma, thyroid gland papillary carcinoma | City of Hope Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05900219 | Sep 2023 → Sep 2025 | non-small cell lung carcinoma | Shanghai Kechow Pharma, Inc. | Unknown | No outcome recorded |
| Phase 2 | NCT05388123 | Mar 2022 → Apr 2026 | hairy cell leukemia | Scripps Health | Completed | No outcome recorded |
| Phase 2 | NCT05233332 | Feb 2022 → Jan 2024 | — | Shanghai Kechow Pharma, Inc. | 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 | NCT05068752 | Oct 2021 → Nov 2024 | malignant pancreatic neoplasm | HonorHealth Research Institute | Completed | No outcome recorded |
| Phase 2 | NCT04551521 | Oct 2021 → Dec 2024 | cancer | German Cancer Research Center | Completed | No outcome recorded |
| Phase 2 | NCT05263453 | Sep 2021 → Sep 2024 | melanoma | Shanghai Kechow Pharma, Inc. | Unknown | No outcome recorded |
| Phase 2 | NCT04817956 | Apr 2021 → Mar 2040 expected | metastatic malignant neoplasm | Oslo University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04943198 | Apr 2021 → Jun 2027 expected | histiocytosis | Anna Raciborska | Recruiting | No outcome recorded |
| Phase 2 | NCT04722575 | Dec 2020 → Dec 2023 overdue | melanoma | Fondazione Melanoma Onlus | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04302025 | Nov 2020 → Nov 2026 expected | non-small cell lung carcinoma | Genentech, Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT04591431 | Oct 2020 → Dec 2024 | breast cancer, digestive system cancer, non-small cell lung carcinoma | Fondazione per la Medicina Personalizzata | Unknown | No outcome recorded |
| Phase 2 | NCT04341181 | Aug 2020 → Apr 2029 expected | cancer | Ulrik Lassen | Recruiting | No outcome recorded |
| Phase 2 | NCT04423185 | Aug 2020 → Jul 2026 overdue | — | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Recruiting | No outcome recorded |
| Phase 2 | NCT03625141 | Dec 2018 → Jun 2021 | metastatic melanoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT03727763 | Oct 2018 → Dec 2021 | colorectal cancer | Shanghai Changzheng Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT03554083 | Oct 2018 → Apr 2025 | cutaneous melanoma | Mayo Clinic | Completed | No outcome recorded |
| Phase 2 | NCT03498521 | Jul 2018 → Feb 2023 | cancer of unknown primary site | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT03430947 | Jul 2018 → Feb 2023 | metastatic malignant neoplasm in the brain, metastatic melanoma | Technical University Dresden | Terminated | No outcome recorded |
| Phase 2 | NCT03585686 | Jun 2018 → Apr 2023 | Langerhans cell histiocytosis | Federal Research Institute of Pediatric Hematology, Oncology and Immunology | Unknown | No outcome recorded |
| Phase 2 | NCT03224208 | May 2018 → Sep 2020 | cutaneous melanoma | Fondazione Melanoma Onlus | Terminated | No outcome recorded |
| Phase 2 | NCT03297606 | Mar 2018 → Dec 2026 expected | non-Hodgkin lymphoma, plasma cell myeloma | Canadian Cancer Trials Group | Recruiting | No outcome recorded |
| Phase 2 | NCT03410875 | Feb 2018 → Jan 2027 expected | hairy cell leukemia | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03224767 | Jan 2018 → Sep 2023 overdue | papillary craniopharyngioma | Alliance for Clinical Trials in Oncology | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03220035 | Nov 2017 → Jun 2022 | Ewing sarcoma, Langerhans cell histiocytosis, Wilms tumor, ependymoma +9 | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT03155620 | Jul 2017 → Mar 2025 overdue | Ewing sarcoma, Langerhans cell histiocytosis, Wilms tumor, conventional osteosarcoma +13 | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03181100 | Jul 2017 → Jul 2027 expected | poorly differentiated thyroid gland carcinoma, thyroid gland undifferentiated (anaplastic) carcinoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03005639 | Jun 2017 → Feb 2018 | melanoma | Inova Health Care Services | Withdrawn | No outcome recorded |
| Phase 2 | NCT02314481 | May 2017 → Nov 2025 | non-small cell lung carcinoma | University College, London | Completed | No outcome recorded |
| Phase 2 | NCT02788201 | Mar 2017 → Oct 2019 | urinary bladder cancer, urothelial carcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT02968303 | Jan 2017 → Oct 2022 | melanoma of soft tissue | Radboud University Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT03239015 | Jan 2017 → Jun 2023 | refractory malignant neoplasm | Baodong Qin | Unknown | No outcome recorded |
| Phase 2 | NCT02902029 | Nov 2016 → Mar 2024 | melanoma | University Hospital, Essen | Completed | No outcome recorded |
| Phase 2 | NCT02925234 | Aug 2016 → Sep 2027 expected | cancer | The Netherlands Cancer Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT02768207 | May 2016 → Dec 2017 | metastatic melanoma | Hoffmann-La Roche | Completed | 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 | NCT02638428 | Dec 2015 → Dec 2021 | childhood acute myeloid leukemia | Samsung Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT02537600 | Dec 2015 → Nov 2019 | melanoma | Center Eugene Marquis | Completed | No outcome recorded |
| Phase 2 | NCT02036086 | Aug 2015 → Jan 2024 | melanoma | Sunnybrook Health Sciences Centre | Unknown | No outcome recorded |
| Phase 2 | NCT02583516 | Jun 2015 → Sep 2019 | melanoma | Spanish Melanoma Group | Completed | No outcome recorded |
| Phase 2 | NCT02291289 | Apr 2015 → May 2019 | colorectal cancer | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT02230306 | Feb 2015 → Mar 2016 | metastatic melanoma | Melissa Burgess, MD | Terminated | No outcome recorded |
| Phase 2 | NCT02303951 | Jan 2015 → May 2020 | melanoma | University Hospital Tuebingen | Terminated | No outcome recorded |
| Phase 2 | NCT02414750 | Dec 2014 → Nov 2020 | metastatic melanoma | Netherlands Working Group on Immunotherapy of Oncology | Terminated | No outcome recorded |
| Phase 2 | NCT02164916 | Nov 2014 → Nov 2017 | colorectal cancer | SWOG Cancer Research Network | Completed | No outcome recorded |
| Phase 2 | NCT02304809 | Oct 2014 → May 2019 overdue | hematopoietic and lymphoid system neoplasm, metastatic malignant neoplasm | UNICANCER | 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 | NCT02091141 | Apr 2014 → May 2023 | biliary tract cancer, salivary gland cancer, urinary bladder cancer | Genentech, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02052193 | Jan → Dec 2014 | metastatic melanoma | University Hospital Tuebingen | Terminated | No outcome recorded |
| Phase 2 | NCT02050321 | Dec 2013 → Dec 2014 | melanoma | University of Arizona | Terminated | No outcome recorded |
| Phase 2 | NCT01942993 | Sep 2013 → Nov 2015 | melanoma | Philip Friedlander | Terminated | No outcome recorded |
| Phase 2 | NCT01495988 | Aug 2013 → Jan 2016 | metastatic melanoma | Melanoma Research Foundation Breakthrough Consortium | Terminated | No outcome recorded |
| Phase 2 | NCT01781026 | Apr 2013 → Jun 2014 | melanoma | Yale University | Completed | No outcome recorded |
| Phase 2 | NCT01813214 | Mar 2013 → Aug 2016 | melanoma | Georgetown University | Terminated | No outcome recorded |
| Phase 2 | NCT01983124 | Feb 2013 → Apr 2014 | metastatic melanoma | Paola Queirolo | Completed | No outcome recorded |
| Phase 2 | NCT01754376 | Jan 2013 → Feb 2015 | melanoma | Massachusetts General Hospital | Terminated | No outcome recorded |
| Phase 2 | NCT01709292 | Nov 2012 → Sep 2026 expected | thyroid cancer | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT01771458 | Oct 2012 → Oct 2016 | refractory malignant neoplasm | Institut Curie | Completed | No outcome recorded |
| Phase 2 | NCT01711632 | Oct 2012 → Aug 2024 | hairy cell leukemia | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT01673854 | Sep 2012 → Jul 2014 | melanoma | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2 | NCT01659151 | Aug 2012 → Oct 2021 | metastatic melanoma | H. Lee Moffitt Cancer Center and Research Institute | Completed | No outcome recorded |
| Phase 2 | NCT01524978 | Apr 2012 → Oct 2016 | plasma cell myeloma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT01474551 | Nov 2011 → Mar 2013 | melanoma | Memorial Sloan Kettering Cancer Center | Terminated | No outcome recorded |
| Phase 2 | NCT01586195 | Oct 2011 → Apr 2015 | melanoma | Genentech, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT01378975 | Jul 2011 → Jul 2015 | melanoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT01286753 | Jun 2011 → Nov 2014 | neoplasm | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT01248936 | Dec 2010 → Oct 2011 | melanoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT01253564 | Nov 2010 → Mar 2012 | melanoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT00949702 | Sep 2009 → Sep 2010 | melanoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| 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 | NCT05768178 | Mar 2023 → Oct 2029 expected | Erdheim-Chester disease, colorectal neoplasm, glioma, laryngeal neoplasm +6 | Cancer Research UK | Recruiting | No outcome recorded |
| Phase 38 trials | ||||||
| Phase 3 | NCT06008119 | Oct 2023 → Dec 2026 expected | colorectal cancer | Shanghai Kechow Pharma, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT03768063 | Feb 2019 → Jul 2028 expected | cancer | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05540951 | Jun 2018 → Aug 2022 | colorectal cancer | Fudan University | Unknown | No outcome recorded |
| Phase 3 | NCT02908672 | Jan 2017 → Oct 2019 | melanoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT01689519 | Jan 2013 → May 2014 | melanoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT01667419 | Sep 2012 → Jun 2017 | melanoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT01307397 | Mar 2011 → Feb 2016 | melanoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT01006980 | Jan → Dec 2010 | melanoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT01898585 | Oct 2013 → May 2019 | melanoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 4 | NCT01739764 | Feb 2013 → Feb 2020 | neoplasm | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 4 | NCT01683188 | Aug 2012 → Nov 2014 | metastatic melanoma | Clinigen, Inc. | Terminated | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT04801966 | Sep 2021 → Dec 2022 | cancer | Peter MacCallum Cancer Centre, Australia | Terminated | No outcome recorded |
| — | NCT01636908 | Aug 2011 → Jan 2018 | cancer | Amsterdam UMC, location VUmc | Completed | No outcome recorded |
Also used as a comparator or background therapy in 6 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01657591 Background | Jul 2012 → Sep 2016 | melanoma | H. Lee Moffitt Cancer Center and Research Institute | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT02427893 Comparator | Aug 2015 → Nov 2016 | melanoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Withdrawn | No outcome recorded |
| Phase 3 | NCT01909453 Comparator | Sep 2013 → Nov 2016 | melanoma | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT01597908 Comparator | Jun 2012 → Apr 2014 | melanoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT04356118 Background | Jun 2020 → Jun 2023 | malignant leptomeningeal tumor | Hui Bu | Unknown | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT02208583 Comparator | Jun 2014 → Dec 2016 | hormone-resistant prostate carcinoma | Tianjin Medical University Cancer Institute and Hospital | Unknown | No outcome recorded |
Press releases naming this drug 9 releases
| Date | Issuer | Release |
|---|---|---|
| 2020-07-31 | Roche Global Development | FDA approves Roche’s Tecentriq plus Cotellic and Zelboraf for people with advanced melanoma roche.com ↗ |
| 2019-12-13 | Roche Global Development | Roche announces positive Phase III study results for Tecentriq plus Cotellic and Zelboraf in people with previously untreated BRAF V600 mutation-positive advanced melanoma roche.com ↗ |
| 2017-11-07 | Roche Global Development | FDA approves Zelboraf (vemurafenib) for Erdheim-Chester disease with BRAF V600 mutation roche.com ↗ |
| 2017-09-11 | Roche Global Development | Roche announces phase III study results of Zelboraf for adjuvant treatment of BRAF V600 mutation-positive melanoma roche.com ↗ |
| 2015-04-28 | Daiichi Sankyo | Daiichi Sankyo Announces Write-off Loss on Trade Rights Related to Consolidated Subsidiary Plexxikon Inc.’s Anticancer Agent Zelboraf daiichisankyo.com ↗ |
| 2012-02-20 | Daiichi Sankyo | Plexxikon Announces European Approval of Zelboraf(R) for the Treatment of Patients with BRAF Mutation-Positive Metastatic Melanoma daiichisankyo.com ↗ |
| 2011-08-17 | Daiichi Sankyo | FDA Approval of Zelboraf(TM) (vemurafenib) Establishes Oncology Foothold in US for Daiichi Sankyo daiichisankyo.com ↗ |
| 2011-06-06 | Daiichi Sankyo | Plexxikon Reports Positive Data from Phase 3 and Phase 2 Trials of Vemurafenib (PLX4032) daiichisankyo.com ↗ |
| 2011-05-11 | Daiichi Sankyo | Vemurafenib New Drug Application Submitted to FDA for Melanoma daiichisankyo.com ↗ |
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 156 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Vemurafenib | “Participants with B-type Raf kinase (BRAF) gene mutations will receive a drug called Vemurafenib, which inhibits a protein called mitogen-activated or extracellular...” NCT02208583 ↗141“BRAF inhibitors (encorafenib, vemurafenib, dabrafenib, etc.) are selected by researchers from the available drugs based on their accessibility” NCT07714447 ↗ “Vemurafenib (960 mg twice a day) will be taken on Days 1 - 28 of each 28-day treatment cycle.” NCT02230306 ↗ “VIC Regimen (Vemurafenib/Irinotecan/Cetuximab)” NCT05540951 ↗ “Vandetanib, Vemurafenib, Vinblastine” NCT02788201 ↗ “BARF Mutation:Vemurafenib” NCT04356118 ↗ “Vemurafenib” NCT02142036 ↗ |
| Known as | PLX4032 | “This open-label, non-randomized study will assess the mass balance, metabolism, routes and rates of elimination as well as efficacy and safety of RO5185426 (RG7204; PLEXXIKON;...” NCT01164891 ↗5“Patients will receive oral Vemurafenib \[RG7204; PLEXXIKON: PLX4032\] at a dose of 960 mg b.i.d. continuously until disease progression or withdrawal from study and will be...” NCT00949702 ↗ “Phase 1 and 2 clinical trials of the BRAF kinase inhibitor vemurafenib (PLX4032) have shown response rates of more than 50% in patients with metastatic melanoma with the BRAF...” PMID 21639808 ↗ Jun 2011 “This open-label single-arm study will evaluate the effect of RO5185426 \[RG7204; PLEXXIKON: PLX4032\] on the pharmacokinetics of five CYP450 substrates” NCT01001299 ↗ “BKM120 Combined with Vemurafenib (PLX4032)” NCT01512251 ↗ |
| Known as | RG7204 | “This open-label, non-randomized study will assess the mass balance, metabolism, routes and rates of elimination as well as efficacy and safety of RO5185426 (RG7204; PLEXXIKON;...” NCT01164891 ↗4“Patients will receive oral Vemurafenib \[RG7204; PLEXXIKON: PLX4032\] at a dose of 960 mg b.i.d. continuously until disease progression or withdrawal from study and will be...” NCT00949702 ↗ “This open-label single-arm study will evaluate the effect of RO5185426 \[RG7204; PLEXXIKON: PLX4032\] on the pharmacokinetics of five CYP450 substrates” NCT01001299 ↗ “Patients will be randomized to receive one of four dose-levels of RO5185426 \[RG7204” NCT01107418 ↗ “PLX4032 (also known as RG7204), an orally available inhibitor of mutated BRAF” PMID 20818844 ↗ Aug 2010 |
| Known as | RO5185426 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01264380 ↗ |
| Known as | RO5185426, Zelboraf | “RO5185426, Zelboraf” NCT01765543 ↗ |
| Known as | VEM | “Participants will receive atezolizumab (Ate) 1200 milligrams (mg) every 3 weeks (q3w) along with vemurafenib (Vem) 720 mg twice daily (BID) for 21 days in each cycle followed...” NCT01656642 ↗2“Ipilimumab (IPI), an anti-CTLA-4 antibody, and vemurafenib (VEM), a BRAF inhibitor, have distinct mechanisms of action and shared toxicities” PMID 27532019 ↗ Aug 2016 “Vemurafenib (VEM)” NCT01897116 ↗ |
| Known as | Vemurafenib = Zelboraf (commercial name) | “Vemurafenib = Zelboraf (commercial name)” NCT02537600 ↗ |
| Known as | Vemurafenib branded as Zelboraf | “Vemurafenib branded as Zelboraf” NCT01638676 ↗ |
| Known as | Vermurafenib | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02115035 ↗ |
| Known as | Zelboraf | “The combination being studied is vemurafenib (also known as Zelboraf®) and High Dose Interleukin-2” NCT01683188 ↗4“combination with Yervoy (Ipilimumab) or With Zelboraf (Vemurafenib)” NCT03013491 ↗ “Zelboraf + Cotellic used outside of indication, based on biomarker” NCT04817956 ↗ “oral BRAF Inhibitor Vemurafenib (Zelboraf®)” NCT01841463 ↗ |
| Known as | ZELBORAF (Vemurafenib) | “ZELBORAF (Vemurafenib)” NCT01876641 ↗ |
| Known as | Zelboraf / RO5185426 | “Zelboraf / RO5185426” NCT01781026 ↗ |
| Known as | Zelboraf for vemurafenib | “Zelboraf for vemurafenib” NCT03005639 ↗ |
| Known as | ZelborafTM | “The purpose of this study is to test a new drug combination consisting of two drugs, vemurafenib (also known as ZelborafTM) and panitumumab (also known as VectibixTM).” NCT01791309 ↗ |
| Action | Inhibit | “PLX4032 is a compound that selectively inhibits oncogenic B-Raf kinase.” NCT00405587 ↗ |
| Modality | Small molecule | “Vemurafenib is a low molecular weight, orally available, inhibitor of BRAF serine-threonine kinase.” NCT02304809 ↗ |
| Route | Oral | “Oral capsules administered BID” NCT00405587 ↗ |
| Target | BRAF | “The oral BRAF inhibitor vemurafenib (PLX4032)” PMID 22356324 ↗ Feb 2012 |