Drugs / Cobimetinib
Cobimetinib
also known as
GDC-0973 · Cob · Cobimetinib = code number RO5514041/F04 · COBIMETINIB FUMARATE · Cobimetinib hemifumarate · Cotellic · Gdc-0973 hemifumarate · RG 7420 · +2 more
Small molecule targets MAP2K1, MAP2K2 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (3) | US (FDA) | COTELLIC | — | 2018-01-26 – 2022-10-28 | fda.gov ↗ |
| Approved | EU (EMA) | Cotellic | — | 2015-11-20 | europa.eu ↗ |
| Approved | US (FDA) | COTELLIC | — | 2015-11-10 | fda.gov ↗ |
Trials 109 · started per year
today
US approved 2015
EU approved 2015
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 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pancreatic ductal adenocarcinoma, pancreatic large cell neuroendocrine carcinoma +2 | OHSU Knight Cancer Institute | Withdrawn | No outcome recorded |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 | NCT04005690 | Aug 2019 → Jun 2026 overdue | pancreatic ductal adenocarcinoma | OHSU Knight Cancer Institute | Recruiting | No outcome recorded |
| Phase 131 trials | ||||||
| Phase 1 | NCT05691504 | Sep 2023 → Feb 2027 expected | endometrial carcinoma, fallopian tube carcinoma, ovarian carcinoma, primary peritoneal carcinoma +1 | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05441514 | Apr 2023 → Mar 2026 | acute myeloid leukemia | City of Hope Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT05034627 | Aug 2022 → Dec 2025 overdue | pancreatic adenocarcinoma | OHSU Knight Cancer Institute | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04835805 | May 2021 → Dec 2026 expected | melanoma | Genentech, Inc. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04190628 | Jun 2020 → Apr 2024 | neoplastic disease or syndrome | ABM Therapeutics Corporation | 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 | NCT04109456 | Mar 2020 → Dec 2024 | metastatic melanoma | InxMed (Shanghai) Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03695380 | Jan 2019 → Jul 2023 | ovarian cancer | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT03178851 | Jun 2017 → May 2019 | melanoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT03284502 | May 2017 → Sep 2024 | metastatic neoplasm | Hanmi Pharmaceutical Company Limited | Unknown | No outcome recorded |
| Phase 1 | NCT02876224 | Sep 2016 → Jun 2019 | colorectal cancer | Hoffmann-La Roche | Completed | 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 | NCT02670044 | Mar 2016 → Dec 2020 | acute myeloid leukemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT02457793 | Jun 2015 → Dec 2016 | colorectal cancer, metastatic melanoma, non-small cell lung carcinoma | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02300025 | Aug 2014 → Jan 2015 | — | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02136524 | Apr → May 2014 | — | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01974258 | Feb → Jul 2014 | neoplasm | Hoffmann-La Roche | Withdrawn | No outcome recorded |
| Phase 1 | NCT01988896 | Dec 2013 → Nov 2019 | cancer | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01986166 | Nov 2013 → Jan 2016 | neoplasm | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01876641 | Oct 2013 → Jun 2018 | metastatic melanoma | Mohammed M Milhem | Terminated | No outcome recorded |
| Phase 1 | NCT01929876 | Jul → Oct 2013 | — | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01711762 | Sep 2012 | — | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01656642 | Aug 2012 → Mar 2020 | melanoma | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01562275 | Apr 2012 → Jan 2015 | neoplasm | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01271803 | Feb 2011 → Oct 2013 | melanoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01277718 | Jan → Feb 2011 | — | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01249131 | Dec 2010 → Jan 2011 | — | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01249118 | Nov 2010 → Jan 2011 | — | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00996892 | Nov 2009 → Mar 2014 | cancer | Genentech, Inc. | Terminated | No outcome recorded |
| Phase 1 | NCT00467779 | May 2007 → Apr 2014 | cancer | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1/214 trials | ||||||
| Phase 1/2 | NCT04214418 | Feb 2020 → Apr 2022 | digestive system cancer | Columbia University | Terminated | No outcome recorded |
| Phase 1/2 | NCT04216953 | Feb 2020 → Dec 2024 | soft tissue sarcoma | Centre Leon Berard | Completed | No outcome recorded |
| Phase 1/2 | NCT03989115 | Jul 2019 → Feb 2022 | cancer | Revolution Medicines, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT03732703 | Apr 2019 → Dec 2024 | refractory plasma cell neoplasm | Multiple Myeloma Research Consortium | Completed | No outcome recorded |
| Phase 1/2 | NCT03566485 | Jul 2018 → Dec 2020 | Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer, female breast carcinoma | Vanderbilt-Ingram Cancer Center | Terminated | No outcome recorded |
| Phase 1/2 | NCT03337698 | Dec 2017 → Oct 2025 | non-small cell lung carcinoma | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 1/2 | NCT03312530 | Nov 2017 → May 2021 | plasma cell myeloma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1/2 | NCT03281369 | Oct 2017 → Oct 2025 | digestive system carcinoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1/2 | NCT03202940 | Sep 2017 → Jan 2029 expected | non-small cell lung carcinoma | Massachusetts General Hospital | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03193190 | Jul 2017 → Feb 2025 | pancreatic adenocarcinoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1/2 | NCT03101254 | Jun 2017 → Oct 2020 | melanoma | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 1/2 | NCT02639546 | May 2016 → Jul 2021 | cancer | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1/2 | NCT01959633 | Apr 2014 → Mar 2018 | melanoma | Fondazione Melanoma Onlus | Completed | No outcome recorded |
| Phase 1/2 | NCT01928394 | Oct 2013 → Feb 2019 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 254 trials | ||||||
| Phase 2 | NCT07449754 | Feb 2026 → Sep 2029 expected | melanoma | Hanmi Pharmaceutical Company Limited | Recruiting | No outcome recorded |
| Phase 2 | NCT06813079 | Apr 2025 → Feb 2028 expected | pancreatic ductal adenocarcinoma | University Health Network, Toronto | 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 | NCT05756556 | Jun 2024 → Dec 2026 | melanoma | ImmVira Pharma Co. Ltd | Suspended | No outcome recorded |
| Phase 2 | NCT06229340 | Oct 2023 → Oct 2026 expected | colorectal cancer, lung cancer, malignant pancreatic neoplasm, melanoma +1 | N.N. Petrov National Medical Research Center of Oncology | Recruiting | No outcome recorded |
| Phase 2 | NCT05125471 | Jul 2022 → Sep 2025 | arteriovenous hemangioma/malformation | University of Arkansas | Completed | No outcome recorded |
| Phase 2 | NCT04941287 | Dec 2021 → Jan 2024 overdue | distal biliary tract carcinoma, gallbladder carcinoma, intrahepatic cholangiocarcinoma | National Cancer Institute (NCI) | Active not recruiting | 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 | NCT04551521 | Oct 2021 → Dec 2024 | cancer | German Cancer Research Center | Completed | No outcome recorded |
| Phase 2 | NCT04931342 | Oct 2021 → Feb 2028 expected | ovarian cancer | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04079179 | Apr 2021 → Dec 2025 overdue | Erdheim-Chester disease, Langerhans cell histiocytosis, histiocytic sarcoma, juvenile xanthogranuloma +3 | Carl Allen | Recruiting | No outcome recorded |
| Phase 2 | NCT04817956 | Apr 2021 → Mar 2040 expected | metastatic malignant neoplasm | Oslo University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04409639 | Jan 2021 → Apr 2025 overdue | chronic myelomonocytic leukemia | University of Utah | Active not 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 | NCT04185831 | Oct 2020 → Jan 2024 overdue | cancer | Uppsala University Hospital | Active not 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 | NCT03625141 | Dec 2018 → Jun 2021 | metastatic melanoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT03600701 | Nov 2018 → Jul 2025 overdue | non-small cell lung carcinoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03554083 | Oct 2018 → Apr 2025 | cutaneous melanoma | Mayo Clinic | Completed | No outcome recorded |
| Phase 2 | NCT03363867 | Jul 2018 → Feb 2024 | fallopian tube cancer, ovarian cancer, primary peritoneal carcinoma | Peter MacCallum Cancer Centre, Australia | Unknown | 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 | NCT03224208 | May 2018 → Sep 2020 | cutaneous melanoma | Fondazione Melanoma Onlus | Terminated | No outcome recorded |
| Phase 2 | NCT03340558 | May 2018 → Feb 2021 | colorectal cancer | Niharika Mettu | Withdrawn | 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 | NCT03201458 | Feb 2018 → Aug 2020 | gallbladder carcinoma, intrahepatic cholangiocarcinoma | National Cancer Institute (NCI) | Completed | 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 | NCT03395899 | Dec 2017 → Aug 2023 | estrogen-receptor positive breast cancer | Queen Mary University of London | Completed | No outcome recorded |
| Phase 2 | NCT03264066 | Nov 2017 → Jun 2020 | cancer | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT03202316 | Aug 2017 → Dec 2027 expected | inflammatory breast carcinoma | M.D. Anderson Cancer Center | 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 | NCT03175432 | Jun 2017 → Jun 2028 expected | central nervous system melanocytic neoplasm, cutaneous melanoma, metastatic malignant neoplasm in the brain, metastatic melanoma | 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 | NCT03108131 | Apr 2017 → Apr 2024 | appendix adenocarcinoma, metastatic malignant neoplasm, neoplastic syndrome, skin squamous cell carcinoma +1 | M.D. Anderson Cancer Center | 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 | 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 | NCT02649972 | Jan 2016 → Dec 2022 | histiocytosis | Memorial Sloan Kettering Cancer Center | Completed | 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 | NCT02322814 | Mar 2015 → Aug 2018 | breast cancer | Hoffmann-La Roche | Terminated | 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 | NCT02091141 | Apr 2014 → May 2023 | biliary tract cancer, salivary gland cancer, urinary bladder cancer | Genentech, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02060188 | Mar 2014 → Oct 2024 | colorectal cancer | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2 | NCT01495988 | Aug 2013 → Jan 2016 | metastatic melanoma | Melanoma Research Foundation Breakthrough Consortium | Terminated | No outcome recorded |
| Phase 2 | NCT01813214 | Mar 2013 → Aug 2016 | melanoma | Georgetown University | Terminated | No outcome recorded |
| Phase 2/32 trials | ||||||
| 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 2/3 | NCT05722886 | Mar 2023 → Oct 2029 expected | cancer, hematopoietic and lymphoid cell neoplasm | Cancer Research UK | Recruiting | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT04007848 | Jul 2019 → Oct 2021 | histiocytosis | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 3 | NCT03768063 | Feb 2019 → Jul 2028 expected | cancer | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03273153 | Dec 2017 → Apr 2019 | melanoma | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 3 | NCT02788279 | Jul 2016 → Mar 2018 | colorectal cancer | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT01689519 | Jan 2013 → May 2014 | melanoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT04801966 | Sep 2021 → Dec 2022 | cancer | Peter MacCallum Cancer Centre, Australia | Terminated | No outcome recorded |
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT02908672 Background | Jan 2017 → Oct 2019 | melanoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT02427893 Comparator | Aug 2015 → Nov 2016 | melanoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Withdrawn | No outcome recorded |
Press releases naming this drug 3 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 ↗ |
| 2018-05-10 | Roche Global Development | Roche provides update on Phase III study of Tecentriq (atezolizumab) and Cotellic (cobimetinib) in people with heavily pre-treated locally advanced or metastatic colorectal cancer roche.com ↗ |
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 113 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Cobimetinib | “Comparing Oral to Intravenous Administration of GDC-0973 (Cobimetinib)” NCT01249118 ↗108“Cobimetinib 60 mg on days 1-21, break 7 days, cycle 28 days orally” NCT06229340 ↗ |
| Known as | Cob | “cobimetinib (Cob) 60 mg IV once daily, 21 days on/7 days off schedule (21/7).” NCT01656642 ↗ |
| Known as | Cobimetinib = code number RO5514041/F04 | “Cobimetinib = code number RO5514041/F04” NCT02537600 ↗ |
| Known as | COBIMETINIB FUMARATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL2146883 ↗ |
| Known as | Cobimetinib hemifumarate | ChEMBL registry synonym — accepted as the source's own label CHEMBL2146883 ↗ |
| Known as | Cotellic | “Zelboraf + Cotellic used outside of indication, based on biomarker” NCT04817956 ↗ |
| Known as | GDC-0973 | “Cobimetinib (GDC-0973, XL518) is a potent and highly selective inhibitor of MEK1 and MEK2, central components of the RAS/RAF pathway.” NCT01813214 ↗ |
| Known as | Gdc-0973 hemifumarate | ChEMBL registry synonym — accepted as the source's own label CHEMBL2146883 ↗ |
| Known as | RG 7420 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2146883 ↗ |
| Known as | Xl-518 hemifumarate | ChEMBL registry synonym — accepted as the source's own label CHEMBL2146883 ↗ |
| Known as | XL518 | “Cobimetinib (GDC-0973, XL518) is a potent and highly selective inhibitor of MEK1 and MEK2, central components of the RAS/RAF pathway.” NCT01813214 ↗ |
| Action | Inhibit | “Dual specificity mitogen-activated protein kinase kinase 2 inhibitor” CHEMBL2146883 ↗1“MEK inhibition with cobimetinib” PMID 25037139 ↗ Jul 2014 |
| Modality | Small molecule | “small-molecule inhibitor” NCT03395899 ↗ |
| Route | Oral | “Repeating oral dose” NCT00467779 ↗ |
| Target | MAP2K1 | “cobimetinib (GDC-0973), a highly selective inhibitor of MEK1” NCT02414750 ↗ |
| Target | MAP2K2 | “Dual specificity mitogen-activated protein kinase kinase 2 inhibitor” CHEMBL2146883 ↗ |