Drugs / Regorafenib
Regorafenib
also known as
BAY73-4506 · Stivarga · BAY 73-4506 monohydrate · Identification code of the investigational drug; BAY73-4506 · REG · REGO · Regorafenib and HAIC · Regorafenib anhydrous · +5 more
Small molecule targets ABL1, BRAF, CSF1R, DDR2, EPHA2, FGFR1, FGFR2, FRK, KIT, MAPK11, NTRK1, PDGFRB, RAF1, RET, STAT3, TEK via inhibition
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | STIVARGA | — | 2017-04-27 – 2018-06-14 | fda.gov ↗ |
| Approved | EU (EMA) | Stivarga | — | 2013-08-26 | europa.eu ↗ |
| Approved | US (FDA) | STIVARGA | — | 2012-09-27 | fda.gov ↗ |
Trials 242 · started per year
today
US approved 2012
EU approved 2013
1
1
4
4
7
1
15
23
18
16
6
10
17
15
17
18
26
13
17
10
2007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT07343791 | Nov 2025 → Nov 2027 expected | colorectal cancer | JIANG LONGWEI | Recruiting | No outcome recorded |
| Phase 142 trials | ||||||
| Phase 1 | NCT06283134 | Mar 2026 → Dec 2027 expected | colorectal cancer | China Medical University, China | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06454409 | May 2025 → Sep 2030 | acute myeloid leukemia, myelodysplastic syndrome | City of Hope Medical Center | Suspended | No outcome recorded |
| Phase 1 | NCT06283303 | Apr 2024 → Nov 2025 | metastasis from malignant tumor of colon | China Medical University, China | Unknown | No outcome recorded |
| Phase 1 | NCT06200363 | Sep 2023 → Nov 2024 | colorectal cancer | West China Hospital | Unknown | No outcome recorded |
| Phase 1 | NCT05830084 | Jun 2023 → Apr 2027 expected | Ewing sarcoma | Gustave Roussy, Cancer Campus, Grand Paris | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05644392 | Nov 2022 → Nov 2025 | — | Tianjin Medical University Cancer Institute and Hospital | Unknown | No outcome recorded |
| Phase 1 | NCT05644379 | Nov 2022 → Nov 2025 overdue | — | Tianjin Medical University Cancer Institute and Hospital | Active not recruiting | No outcome recorded |
| Phase 1 | NCT06095375 | Jul 2022 → Oct 2024 | IDH-wildtype glioblastoma | Veneto Institute of Oncology IRCCS | Completed | No outcome recorded |
| Phase 1 | NCT05155189 | Feb 2022 → May 2026 overdue | hepatocellular carcinoma | Zhejiang University | Recruiting | No outcome recorded |
| Phase 1 | NCT04819516 | Dec 2020 → Dec 2025 | colorectal cancer | Second Affiliated Hospital, School of Medicine, Zhejiang University | Unknown | No outcome recorded |
| Phase 1 | NCT04362839 | May 2020 → Dec 2025 | colon adenocarcinoma, rectum adenocarcinoma | City of Hope Medical 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 Stop: Enrollment |
| Phase 1 | NCT03712943 | Oct 2018 → Sep 2021 | colon carcinoma | H. Lee Moffitt Cancer Center and Research Institute | Completed | No outcome recorded |
| Phase 1 | NCT03347292 | Jun 2018 → Dec 2020 | hepatocellular carcinoma | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT03475251 | May 2018 → May 2021 | cancer of unknown primary site | CStone Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT03305913 | Jul 2017 → Oct 2018 | colorectal cancer | AIO-Studien-gGmbH | Completed | No outcome recorded |
| Phase 1 | NCT03081494 | Jun 2017 → May 2019 | colorectal cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT03042689 | Apr 2017 → Sep 2021 | acute myeloid leukemia | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 1 | NCT02910843 | Feb 2017 → Dec 2021 | rectal cancer | Swiss Cancer Institute | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT02439723 | Mar 2016 → Jun 2017 | metastatic malignant neoplasm | AHS Cancer Control Alberta | Withdrawn | No outcome recorded |
| Phase 1 | NCT02466802 | Jul 2015 → Jan 2019 | neoplasm | Virginia Commonwealth University | Completed | No outcome recorded |
| Phase 1 | NCT02398513 | Apr → Nov 2015 | — | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT02116894 | Aug 2014 → Feb 2016 | colorectal cancer | Duke University | Completed | No outcome recorded |
| Phase 1 | NCT02164240 | Jul 2014 → Dec 2016 | gastrointestinal stromal tumor | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 1 | NCT02168777 | Jun 2014 → Oct 2015 | neoplasm | Bayer | Terminated | No outcome recorded |
| Phase 1 | NCT02199223 | Jun 2014 → May 2016 | colorectal cancer | University of Utah | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT02106845 | Apr 2014 → Apr 2015 | neoplasm | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT02085148 | Apr 2014 → May 2019 | childhood malignant neoplasm | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT02095054 | Mar 2014 → Mar 2020 | high grade malignant neoplasm | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT02001909 | Dec 2013 → Apr 2014 | neoplasm | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT01973868 | Nov 2013 → Jan 2017 | neoplasm | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT01853046 | Jun 2013 → Jul 2015 | neoplasm | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT01287598 | Aug 2011 → Jul 2018 | neoplasm | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT01339104 | Apr 2011 → Aug 2013 | neoplasm | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT01318265 | Mar → Jul 2011 | — | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT01322438 | Mar → Jun 2011 | neoplasm | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT01187615 | Aug 2010 → Jun 2012 | small cell lung carcinoma | Bayer | Terminated | No outcome recorded |
| Phase 1 | NCT01096030 | Jul 2010 → Nov 2012 | neoplasm | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT01002378 | Oct 2009 → Feb 2010 | — | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT00934882 | Aug 2009 → Apr 2012 | colorectal neoplasm | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT00960258 | Jul 2009 → Apr 2010 | neoplasm | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT01117623 | Feb 2007 → Nov 2013 | neoplasm | Bayer | Completed | No outcome recorded |
| Phase 1/229 trials · 1 missed | ||||||
| Phase 1/2 | NCT07137390 | Sep 2025 → Jan 2026 | colorectal cancer | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT07040228 | May 2025 → May 2027 expected | malignant pancreatic neoplasm | Junjie Hang | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06682611 | Nov 2024 → Nov 2026 expected | — | Shanghai Runshi Pharmaceutical Technology Co., Ltd | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06047379 | Nov 2023 → Feb 2027 expected | IDH-wildtype glioblastoma, cervical cancer, colorectal cancer, cutaneous neuroendocrine carcinoma +11 | Neonc Technologies, Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05773105 | Sep 2023 → Mar 2026 | hepatocellular carcinoma | Sun Yat-sen University | Completed | No outcome recorded |
| Phase 1/2 | NCT05672316 | May 2023 → Apr 2026 overdue | colorectal adenocarcinoma | City of Hope Medical Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05770882 | Apr 2023 → Jan 2025 | hepatocellular carcinoma | Great Novel Therapeutics Biotech & Medicals Corporation | Terminated | No outcome recorded |
| Phase 1/2 | NCT05731947 | Apr 2023 → Jun 2025 | colorectal cancer | Syndax Pharmaceuticals | Terminated | No outcome recorded |
| Phase 1/2 | NCT05426811 | Jul 2022 → Jul 2025 | colorectal neoplasm | China Medical University, China | Unknown | No outcome recorded |
| Phase 1/2 | NCT05394740 | Jun 2022 → Apr 2024 | esophageal adenocarcinoma, gastric adenocarcinoma, gastroesophageal junction adenocarcinoma | National Cancer Center Hospital East | Completed | No outcome recorded |
| Phase 1/2 | NCT05395741 | Apr 2022 → Sep 2025 | Ewing sarcoma of bone, osteosarcoma | Institute of Mother and Child, Warsaw, Poland | Completed | No outcome recorded |
| Phase 1/2 | NCT04781192 | Mar 2022 → Nov 2025 overdue | biliary tract cancer | University of Kansas Medical Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04625907 | Sep 2020 → Jun 2030 expected | rhabdomyosarcoma | University of Birmingham | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04446091 | Jul 2020 → Jul 2021 | colorectal cancer | Zhejiang Cancer Hospital | Unknown | No outcome recorded |
| Phase 1/2 | NCT04170556 | Mar 2020 → Jul 2024 | hepatocellular carcinoma | Fundacion Clinic per a la Recerca Biomédica | Completed | No outcome recorded |
| Phase 1/2 | NCT04200404 | Dec 2019 → May 2021 | refractory malignant neoplasm | CStone Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/2 | NCT04008511 | Jul 2019 → Mar 2023 | colorectal cancer | China Medical University, China | Unknown | No outcome recorded |
| Phase 1/2 | NCT03657641 | Jun 2019 → Feb 2023 overdue | colorectal cancer | University of Southern California | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03828799 | May 2019 → Dec 2021 | colorectal cancer | Institut du Cancer de Montpellier - Val d'Aurelle | Completed | No outcome recorded |
| Phase 1/2 | NCT03946917 | Mar 2019 → May 2020 | colorectal cancer | Sun Yat-sen University | Unknown | No outcome recorded |
| Phase 1/2 | NCT04110093 | Mar 2019 → Aug 2021 | colorectal cancer | Shanghai Changzheng Hospital | Unknown | No outcome recorded |
| Phase 1/2 | NCT03722108 | Feb 2019 → May 2022 | gastric adenocarcinoma, gastroesophageal junction adenocarcinoma | UNICANCER | Terminated | No outcome recorded |
| Phase 1/2 | NCT03563157 | Sep 2018 → Apr 2019 | colorectal cancer | ImmunityBio, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT03555149 | Sep 2018 → Sep 2022 | colorectal cancer | Hoffmann-La Roche | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT03475953 | May 2018 → Dec 2024 | biliary tract cancer, colorectal cancer, digestive system neuroendocrine neoplasm, gastroesophageal cancer +9 | Institut Bergonié | Unknown | No outcome recorded |
| Phase 1/2 | NCT03377361 | Jan 2018 → Nov 2024 | colorectal carcinoma | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1/2 | NCT02406170 | Apr 2015 → Oct 2019 | esophageal cancer, gastric cancer, metastatic neoplasm | Academic Medical Center - University of Amsterdam | Completed | No outcome recorded |
| Phase 1/2 | NCT02386397 | Sep 2014 → Dec 2019 | digestive system cancer | Institut du Cancer de Montpellier - Val d'Aurelle | Completed | Missed primary |
| Phase 1/2 | NCT02024607 | Jan 2014 → Mar 2019 | digestive system cancer | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 2137 trials · 6 met primary · 8 missed | ||||||
| Phase 2 | NCT06902246 | Aug 2026 → Aug 2031 | hepatocellular carcinoma | University of Miami | Withdrawn | No outcome recorded |
| Phase 2 | NCT07463248 | Apr 2026 → Jan 2028 expected | hepatocellular carcinoma | Wang Xin | Recruiting | No outcome recorded |
| Phase 2 | NCT07495579 | Apr 2026 → Apr 2028 expected | hepatocellular carcinoma | Asan Medical Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07514429 | Mar 2026 → May 2028 expected | hepatocellular carcinoma | Ju Hyun Shim | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07514455 | Mar 2026 → May 2028 expected | hepatocellular carcinoma | Ju Hyun Shim | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06558773 | Mar 2026 → Mar 2027 expected | colorectal cancer | Chinese PLA General Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07071961 | Feb 2026 → May 2027 | colorectal cancer | M.D. Anderson Cancer Center | Suspended | No outcome recorded |
| Phase 2 | NCT07501351 | Jan → Oct 2026 expected | hepatocellular carcinoma | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 2 | NCT07223567 | Oct 2025 → Jan 2026 | rectal cancer | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT07213570 | Oct 2025 → Oct 2026 expected | colorectal cancer | National Cancer Institute, Naples | Recruiting | No outcome recorded |
| Show all 137 trials opens the full record — a long page | ||||||
| Phase 2/34 trials · 1 missed | ||||||
| Phase 2/3 | NCT06820957 | Nov 2025 → Jun 2026 | CIC-rearranged sarcoma, Ewing sarcoma, round cell sarcoma with EWSR1-non-ETS fusion, sarcoma with BCOR genetic alterations +1 | Children's Oncology Group | Terminated | No outcome recorded |
| Phase 2/3 | NCT05462613 | May 2023 → Nov 2029 expected | colorectal cancer | Centre Hospitalier Universitaire de Besancon | Recruiting | No outcome recorded |
| Phase 2/3 | NCT03970447 | Jul 2019 → Jun 2028 expected | glioblastoma | Global Coalition for Adaptive Research | Recruiting | Missed primary |
| Phase 2/3 | NCT01189903 | Jan 2011 → Aug 2013 | colorectal cancer | National University Hospital, Singapore | Unknown | No outcome recorded |
| Phase 315 trials · 5 met primary · 2 missed | ||||||
| Phase 3 | NCT07483684 | Mar 2026 → Aug 2027 expected | carcinoma | Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06992648 | Apr 2025 → Dec 2027 expected | colorectal cancer | Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | No outcome recorded |
| Phase 3 | NCT06199973 | Mar 2024 → Apr 2026 overdue | colorectal cancer | Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04777851 | Oct 2023 → Feb 2026 | hepatocellular carcinoma | Translational Research in Oncology | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT04879368 | May 2021 → Jan 2025 | gastroesophageal cancer | Australasian Gastro-Intestinal Trials Group | Completed | Missed primary |
| Phase 3 | NCT03829462 | Mar 2019 → Sep 2024 overdue | colorectal cancer | Institut du Cancer de Montpellier - Val d'Aurelle | Active not recruiting | Missed primary |
| Phase 3 | NCT02773524 | Nov 2016 → Jan 2022 | gastroesophageal cancer | Australasian Gastro-Intestinal Trials Group | Unknown | Met primary |
| Phase 3 | NCT02664077 | Jun 2016 → Oct 2019 | colorectal cancer | NSABP Foundation Inc | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT01939223 | Dec 2013 → Aug 2016 | colorectal cancer | Bayer | Terminated | No outcome recorded |
| Phase 3 | NCT01853319 | Jul 2013 → Apr 2015 | colorectal neoplasm | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT01786538 | Jun 2013 → May 2016 | colorectal cancer | Asan Medical Center | Withdrawn | No outcome recorded |
| Phase 3 | NCT01774344 | May 2013 → Feb 2016 | hepatocellular carcinoma | Bayer | Completed | Met primary |
| Phase 3 | NCT01584830 | Apr 2012 → Nov 2013 | colorectal neoplasm | Bayer | Completed | Met primary |
| Phase 3 | NCT01271712 | Jan 2011 → Jan 2012 | gastrointestinal stromal tumor | Bayer | Completed | Met primary |
| Phase 3 | NCT01103323 | Apr 2010 → Jul 2011 | colorectal cancer | Bayer | Completed | Met primary |
| Phase 43 trials | ||||||
| Phase 4 | NCT04874207 | Oct 2021 → Apr 2025 | colorectal cancer | Rennes University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT03564938 | Jul 2018 → Mar 2023 | colorectal cancer | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT02800330 | May 2016 → Feb 2018 | colorectal neoplasm, gastrointestinal stromal tumor | Erasmus Medical Center | Completed | No outcome recorded |
| Phase not applicable8 trials | ||||||
| — | NCT07115550 | Aug 2025 → Aug 2027 expected | hepatocellular carcinoma | Huai'an First People's Hospital | Not yet recruiting | No outcome recorded |
| — | NCT06456515 | May 2024 → Mar 2026 overdue | colorectal cancer | The First People's Hospital of Changzhou | Recruiting | No outcome recorded |
| — | NCT05818267 | Jun 2023 → Mar 2025 | colorectal cancer | Wei Zhang | Unknown | No outcome recorded |
| — | NCT04055220 | Mar 2020 → Oct 2026 expected | Ewing sarcoma, angiosarcoma, chondrosarcoma, leiomyosarcoma +2 | Centre Leon Berard | Recruiting | No outcome recorded |
| — | NCT02551718 | Sep 2015 → Jun 2020 | acute leukemia of ambiguous lineage, acute lymphoblastic leukemia | University of Washington | Completed | No outcome recorded |
| — | NCT02175095 | Jul 2014 → Aug 2016 | colorectal cancer | Asan Medical Center | Completed | No outcome recorded |
| — | NCT03698253 | Oct 2013 → Jun 2018 | colorectal cancer | Kaohsiung Medical University Chung-Ho Memorial Hospital | Completed | No outcome recorded |
| — | NCT01996969 | Oct 2013 → Jun 2015 | colorectal cancer | Seoul National University Hospital | Completed | No outcome recorded |
| Phase not stated3 trials | ||||||
| — | NCT01646593 | — | gastrointestinal stromal tumor | Bayer | No longer available | No outcome recorded |
| — | NCT01538680 | — | colorectal cancer | Bayer | No longer available | No outcome recorded |
| — | NCT01689376 | — | gastrointestinal stromal tumor | Bayer | No longer available | No outcome recorded |
| Comparator or background therapy59 trials | ||||||
| Phase 1 | NCT07567222 Background | Jun → Dec 2026 expected | cancer | West China Hospital | Recruiting | No outcome recorded |
| Phase 1 | NCT06363006 Background | Mar 2024 → Jan 2026 overdue | hepatocellular carcinoma | Peking Union Medical College Hospital | Recruiting | No outcome recorded |
| Phase 1 | NCT03406871 Comparator | Jan 2018 → Dec 2020 | — | Kohei Shitara | Completed | No outcome recorded |
| Phase 1 | NCT03215264 Background | Oct 2017 → Jun 2020 | colorectal cancer | Abramson Cancer Center at Penn Medicine | Completed | No outcome recorded |
| Phase 1/2 | NCT07857135 Comparator | Oct 2026 → Feb 2029 expected | — | CSPC Megalith Biopharmaceutical Co.,Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT04660812 Comparator | May 2021 → Sep 2025 | colorectal cancer | Arcus Biosciences, Inc. | Completed | Met primary |
| Phase 1/2 | NCT03994601 Background | Sep 2019 → Aug 2024 | cancer of unknown primary site | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1/2 | NCT01896856 Comparator | Oct 2013 → Aug 2019 | — | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed | No outcome recorded |
| Phase 2 | NCT07691645 Background | Sep 2026 → Aug 2029 expected | hepatocellular carcinoma | Xiang-Qian | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07535632 Comparator | Jun 2026 → Jun 2028 expected | colorectal neoplasm | Shanghai Zhongshan Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07353268 Comparator | Jan 2026 → Aug 2027 expected | colorectal cancer | Tao Zhang | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07328009 Comparator | Jan 2026 → Jan 2029 expected | hepatocellular carcinoma | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT07310173 Comparator | Jan 2026 → Oct 2027 expected | hepatocellular carcinoma | Zhejiang Hisun Pharmaceutical Co. Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT07078305 Comparator | Aug 2025 → Aug 2026 overdue | hepatocellular carcinoma | Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06946849 Background | Jun 2025 → May 2027 expected | intrahepatic cholangiocarcinoma | Shanghai Zhongshan Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06949982 Comparator | Mar 2025 → Apr 2027 expected | colorectal cancer | Sergey Orlov, MD | Recruiting | No outcome recorded |
| Phase 2 | NCT06829355 Background | Feb → Dec 2025 overdue | colorectal cancer | Beijing Friendship Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06592612 Comparator | Oct 2024 → Oct 2026 expected | hepatocellular carcinoma | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06425133 Comparator | Jul 2024 → Sep 2027 expected | colorectal cancer | Centre Hospitalier Universitaire de Besancon | Recruiting | No outcome recorded |
| Phase 2 | NCT06089330 Comparator | Jan → Jul 2024 | colorectal cancer | Shanghai JMT-Bio Inc. | Unknown | No outcome recorded |
| Phase 2 | NCT06543836 Comparator | Dec 2023 → Nov 2025 overdue | colorectal cancer | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Recruiting | No outcome recorded |
| Phase 2 | NCT05962450 Background | Oct 2023 → Aug 2025 | hepatocellular carcinoma | Beijing YouAn Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05820906 Background | Sep 2023 → Sep 2024 | biliary tract cancer | Tianjin Medical University Cancer Institute and Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05673824 Background | Jan 2023 → Sep 2025 | poisoning | Fudan University | Completed | No outcome recorded |
| Phase 2 | NCT05608044 Comparator | Nov 2022 → Sep 2027 expected | colorectal cancer | Agenus Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05278351 Comparator | Jul 2022 → Apr 2024 | colorectal cancer | Shanghai Zhongshan Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04327700 Background | Jan 2021 → May 2024 | hepatocellular carcinoma | Wake Forest University Health Sciences | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04476329 Comparator | Jan → Oct 2021 | hepatocellular carcinoma | SC Liver Research Consortium, LLC | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03992456 Comparator | Apr 2020 → Dec 2023 | colon adenocarcinoma, rectum adenocarcinoma | Academic and Community Cancer Research United | Unknown | Missed primary |
| Phase 2 | NCT02955940 Background | Nov 2016 → Sep 2027 expected | breast cancer, colorectal cancer, lung cancer, malignant pancreatic neoplasm | Incyte Corporation | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02651415 Background | Aug 2016 → Mar 2018 | colorectal cancer | British Columbia Cancer Agency | Completed | No outcome recorded |
| Phase 2 | NCT02316340 Comparator | Feb 2015 → Mar 2018 | colorectal cancer | The University of Texas Health Science Center at San Antonio | Completed | Missed primary |
| Phase 2 | NCT02402036 Background | Feb 2015 → Nov 2017 | colon carcinoma | Georgetown University | Terminated | No outcome recorded |
| Phase 2 | NCT02288078 Comparator | Oct 2014 → Sep 2015 | rectal cancer | Clinical Research Support Center Kyush | Unknown | No outcome recorded |
| Phase 2 | NCT02048371 Comparator | Jul 2014 → May 2022 | Ewing sarcoma, bone osteosarcoma, liposarcoma, mesenchymal chondrosarcoma +1 | Sarcoma Alliance for Research through Collaboration | Completed | No outcome recorded |
| Phase 2 | NCT02096354 Comparator | May 2014 → Apr 2018 | colorectal cancer | EpicentRx, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02162914 Comparator | Mar 2014 → Mar 2019 | cholangiocarcinoma | Erasme University Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT02119676 Background | Mar 2014 → Feb 2016 | colorectal cancer | Incyte Corporation | Terminated | Missed primary Stop: Business |
| Phase 2 | NCT01298570 Comparator | Apr 2011 → Nov 2016 | colorectal cancer | UNC Lineberger Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 2/3 | NCT07379047 Comparator | May 2026 → Aug 2028 expected | gastrointestinal stromal tumor | Ningbo Newbay Technology Development Co., Ltd | Recruiting | No outcome recorded |
| Phase 2/3 | NCT07392866 Comparator | Mar 2026 → Mar 2030 expected | hepatocellular carcinoma | Nanjing Sanhome Pharmaceutical, Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT07300488 Comparator | Sep 2025 → Feb 2027 expected | hepatocellular carcinoma | Xi'an Xintong Pharmaceutical Research Co.,Ltd. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT07384377 Comparator | Feb 2026 → Nov 2027 expected | carcinoma | Shanghai JMT-Bio Inc. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07134205 Comparator | Oct 2025 → Jun 2027 expected | colorectal cancer | Shanghai JMT-Bio Inc. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06841172 Comparator | Jul 2025 → Jul 2027 expected | hepatocellular carcinoma | Shandong Cancer Hospital and Institute | Recruiting | No outcome recorded |
| Phase 3 | NCT05794971 Comparator | Jun 2023 → Mar 2027 expected | metastasis from malignant tumor of colon | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 3 | NCT05425940 Comparator | Sep 2022 → Jun 2026 overdue | colorectal cancer | Exelixis | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05600309 Comparator | Jun 2022 → Aug 2024 | colorectal cancer | Merck Sharp & Dohme LLC | Completed | Missed primary |
| Phase 3 | NCT05328908 Comparator | Apr 2022 → Jul 2025 | colorectal neoplasm | Bristol-Myers Squibb | Terminated | No outcome recorded |
| Phase 3 | NCT05198934 Comparator | Apr 2022 → Jul 2025 | colorectal cancer | Amgen | Completed | Met primary |
| Phase 3 | NCT05064059 Comparator | Nov 2021 → Aug 2024 | colorectal cancer | Merck Sharp & Dohme LLC | Completed | Missed primary |
| Phase 3 | NCT04985136 Comparator | Sep → Dec 2021 | hepatocellular carcinoma | Jiangsu HengRui Medicine Co., Ltd. | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT04776148 Comparator | Mar 2021 → Sep 2024 | colorectal neoplasm | Merck Sharp & Dohme LLC | Completed | Missed primary |
| Phase 3 | NCT03465722 Comparator | Mar 2018 → Mar 2020 | gastrointestinal stromal tumor | Blueprint Medicines Corporation | Completed | Missed primary |
| Phase 3 | NCT02788279 Comparator | Jul 2016 → Mar 2018 | colorectal cancer | Hoffmann-La Roche | Completed | Missed primary |
| Phase 3 | NCT02934529 Comparator | Mar 2015 → Jan 2025 | colorectal cancer | Ludwig-Maximilians - University of Munich | Completed | No outcome recorded |
| Phase 4 | NCT02287025 Background | Nov 2014 → Feb 2016 | — | Bayer | Terminated | No outcome recorded |
| — | NCT05233358 Background | Feb 2022 → Feb 2023 | hepatocellular carcinoma | The Central Hospital of Lishui City | Unknown | No outcome recorded |
| — | NCT07537985 Comparator | Jan 2020 → Aug 2025 | hepatocellular carcinoma | Sun Yat-sen University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2025-10-20 | Exelixis | Results Exelixis Announces Detailed Results from Phase 3 STELLAR-303 Pivotal Trial Evaluating Zanzalintinib in Combination with an Immune Checkpoint Inhibitor in Metastatic Colorectal Cancer Presented at ESMO 2025 and Published in The Lancet exelixis.com ↗
At a median follow-up of 18.0 months, median overall survival (OS) in the ITT population was 10.9 months with zanzalintinib in combination with atezolizumab versus 9.4 months with regorafenib. |
| 2025-06-22 | Exelixis | Results Exelixis Announces Zanzalintinib in Combination with an Immune Checkpoint Inhibitor Improved Overall Survival in STELLAR-303 Phase 3 Pivotal Trial in Patients with Metastatic Colorectal Cancer exelixis.com ↗ |
| 2025-01-22 | Agenus Inc. | Results Agenus Presents Data at ASCO GI Demonstrating Impact of BOT/BAL in Colorectal Cancer Across Neoadjuvant and Advanced Disease agenusbio.com ↗
Standard of care had no responses. |
| 2020-06-16 | Mendus | Results Immunicum AB (publ) Announces Publication of Phase I/II Clinical Trial Results of Ilixadencel in Gastrointestinal Stromal Tumors (GIST) in Cancer Immunology, Immunotherapy mendus.com ↗
The same two patients also exhibited stable disease for 9 months (on third line regorafenib) and 12 months (on second line sunitinib), respectively, based on the modified RECIST criteria. |
| 2020-05-19 | Ipsen | Results Ipsen announces publication of first matching-adjusted indirect comparison of Cabometyx® (cabozantinib) versus regorafenib in advanced hepatocellular carcinoma in Advances in Therapy ipsen.com ↗
The MAIC shows that Cabometyx® (cabozantinib) increased median progression-free survival by 80.6% (5.6 months vs. 3.1 months) compared with regorafenib in the 2L treatment of aHCC1 |
| 2019-09-20 | Ipsen | Results Ipsen to present new data at 13th Annual Conference of the International Liver Cancer Association (ILCA 2019) ipsen.com ↗
Results from a matching-adjusted indirect comparison (MAIC) suggest that cabozantinib provides two additional months of progression-free survival versus regorafenib in the second-line treatment of advanced hepatocellular carcinoma |
| 2018-09-28 | Taiho Oncology, Inc. | Results Taiho Oncology Presents Real-World Adherence Data for LONSURF® (trifluridine and tipiracil) in Metastatic Colorectal Cancer at ASCO Quality of Care Symposium taihooncology.com ↗
Treatment with LONSURF was associated with significantly higher medication adherence and longer time to discontinuation compared to treatment with regorafenib. |
| 2018-05-10 | Hoffmann-La Roche | Results 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 ↗
The study evaluated the combination in people with difficult-to-treat, locally advanced or metastatic colorectal cancer (CRC) whose disease progressed or who were intolerant to at least two systemic chemotherapy regimens. |
| 2017-12-13 | Bayer | Regulatory Bayer receives approval in China for Stivarga® (regorafenib) for the second-line systemic treatment of liver cancer bayer.com ↗
Berlin, December 13, 2017 - Bayer announced today that the Chinese Food and Drug Administration (CFDA) approved Stivarga® (regorafenib) tablets for the second-line treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with Nexavar® (sorafenib). |
| 2017-08-07 | Bayer | Regulatory Bayer Receives EU Approval for Stivarga® (Regorafenib) for the Second-Line Systemic Treatment of Liver Cancer bayer.com ↗
Bayer today announced the European Commission (EC) has granted marketing authorization for Stivarga® (regorafenib) for the treatment of adult patients with HCC who have been previously treated with Nexavar® (sorafenib). |
| 2016-01-27 | Incyte Corporation | Results Incyte Announces Decision to Stop Phase 2 Sub-study of Ruxolitinib Plus Regorafenib in Patients with Metastatic Colorectal Cancer and High CRP incyte.com ↗
The decision to stop the sub-study was made after a planned interim analysis of the high CRP subgroup demonstrated that ruxolitinib plus regorafenib did not show a sufficient level of efficacy to warrant continuation. |
All press releases naming this drug 16 releases
Evidence & citations 26 cited values
Every value below carries the sentence it was read from. 308 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Regorafenib | “The choice of the specific multi-kinase inhibitor, including sorafenib, lenvatinib, or regorafenib, will be determined by the researchers based on factors such as the...” NCT06041490 ↗298“Treatment period: Therapeutic agents were selected according to clinical routine, including but not limited to Sorafenib, Lenvatinib, Donafenib, Regorafenib, Apatinib and Cabozantinib.” NCT05673824 ↗ “In some small trials, PD-1 monoclonal antibody combined with Regorafenib showed initial efficacy in patients with MSS type advanced colorectal cancer.” NCT04745130 ↗ “The second-line control group was treated with Regorafenib 80mg once a day, taken for three weeks and rested for one week.” NCT07463248 ↗ “For patients who received sorafenib as FLST, regorafenib will be the preferred second-line option.” NCT06841172 ↗ “SARC024: A Blanket Protocol to Study Oral Regorafenib in Patients With Selected Sarcoma Subtypes” NCT02048371 ↗ “Regorafenib is the standard multi-kinase inhibitor for refractory metastatic colorectal cancer” NCT03946917 ↗ “Regorafenib:in dose ramping stage,the initial dose is 80mg per dose, taken orally once a day.” NCT05933980 ↗ “Regorafenib. Fruquintinib. Trifluridine/Tipiracil (TAS-102) with or without Bevacizumab.” NCT07353268 ↗ “Targeted therapy, with agents including but not limited to regorafenib and apatinib.” NCT07691645 ↗ “lenvatinib or regorafenib will be used for second-line treatment” NCT06592612 ↗ |
| Known as | BAY 73-4506 monohydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1946170 ↗ |
| Known as | BAY73-4506 | “Regorafenib (BAY 73-4506) is an orally available multikinase inhibitor with activity against multiple targets, including tumor angiogenesis (VEGFR-1, -2, -3 and TIE-2),...” NCT02175095 ↗52“Regorafenib (BAY 73-4506, Stivarga®) is an oral diphenylurea multi-kinase inhibitor that targets angiogenic (VEGFR1-3, TIE2), stromal (PDGFR-β, FGFR), and oncogenic receptor...” PMID 30069758 ↗ 2018 “A Phase 1, Non-Randomized, Open Label Study to Determine the Effect of Rifampin on the Pharmacokinetics of a Single Oral Dose of 160 mg Regorafenib (BAY73-4506) in Healthy Volunteers” NCT01322438 ↗ “Regorafenib (BAY 73-4506) is a novel, orally active, diphenylurea multikinase inhibitor of VEGFR1-3, c-KIT, TIE-2, PDGFR-β, FGFR-1, RET, RAF-1, BRAF and p38 MAP kinase.” NCT02501551 ↗ “A phase I dose-escalation study of regorafenib (BAY 73-4506), an inhibitor of oncogenic, angiogenic, and stromal kinases, in patients with advanced solid tumors.” PMID 22421192 ↗ Mar 2012 “Regorafenib (BAY 73-4506) is an oral small molecule tyrosine kinase inhibitor (TKI) that potently blocks multiple protein kinases” NCT04476329 ↗ “Regorafenib (BAY 73-4506) was assessed in metastatic colorectal cancer in the phase III randomized CORRECT trial.” NCT02386397 ↗ “Regorafenib (BAY73-4506) - sequential / Cisplatin / Pemetrexed” NCT01187615 ↗ “Regorafenib, ophthalmic oily suspension (BAY73-4506)” NCT02222207 ↗ “Single Oral Dose of Regorafenib (BAY73-4506)” NCT01318265 ↗ “Regorafenib (Stivarga, BAY73- 4506)” NCT01853319 ↗ |
| Known as | Identification code of the investigational drug; BAY73-4506 | “Identification code of the investigational drug; BAY73-4506” NCT03406871 ↗ |
| Known as | REG | “oral fluoropyrimidine trifluridine/tipiracil (FTD/TPI) combined with the multi-kinase inhibitor regorafenib (REG)” PMID 33993741 ↗ May 2021 |
| Known as | REGO | “PURPOSE: This prospective pharmacokinetic (PK) ancillary study of the TEXCAN phase II GERCOR trial of patients with chemorefractory metastatic colorectal cancer and treated...” PMID 35489233 ↗ Apr 2022 |
| Known as | Regorafenib and HAIC | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05535647 ↗ |
| Known as | Regorafenib anhydrous | ChEMBL registry synonym — accepted as the source's own label CHEMBL1946170 ↗ |
| Known as | Regorafenib hydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1946170 ↗ |
| Known as | Regorafenib monohydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1946170 ↗ |
| Known as | Regorafenib(Stivarga) | “Regorafenib(Stivarga)” NCT06558773 ↗ |
| Known as | Stivarga | “Either Lonsurf® or Stivarga® administered per the investigator's choice at the respective drug label's dose and schedule.” NCT05731947 ↗28“Brand name of regorafenib is Stivarga; brand name of nivolumab is Opdivo.” NCT04126733 ↗ “Regorafenib (Stivarga, BAY73- 4506)” NCT01853319 ↗ “Regorafenib, (Stivarga, BAY73-4506)” NCT04704154 ↗ “Regorafenib (Stivarga, BAY73-4506)” NCT06246643 ↗ “Regorafenib (Stivarga, BAY73-4506)” NCT02465502 ↗ “Regorafenib (Stivarga, BAY73-4506)” NCT01853046 ↗ “Regorafenib (Stivarga, BAY73-4506)” NCT01103323 ↗ “Regorafenib (Stivarga, BAY73-4506)” NCT01289821 ↗ “Regorafenib (Stivarga, BAY73-4506)” NCT00664326 ↗ “Regorafenib (Stivarga, BAY73-4506)” NCT02398513 ↗ |
| Known as | Stivarga (regorafenib) | “Stivarga® (regorafenib)” NCT04777851 ↗ |
| Known as | Stivarga (regorafenib) or "regorafenib" | “Stivarga (regorafenib) or "regorafenib"” NCT02651415 ↗ |
| Action | Inhibit | “Discoidin domain-containing receptor 2 inhibitor” CHEMBL1946170 ↗7“Regorafenib inhibits VEGF receptors 1, 2, and 3” PMID 22959186 ↗ Sep 2012 “Fibroblast growth factor receptor 2 inhibitor” CHEMBL1946170 ↗ “Nerve growth factor receptor Trk-A inhibitor” CHEMBL1946170 ↗ “Tyrosine-protein kinase FRK inhibitor” CHEMBL1946170 ↗ “Tyrosine-protein kinase ABL inhibitor” CHEMBL1946170 ↗ “Ephrin type-A receptor 2 inhibitor” CHEMBL1946170 ↗ “MAP kinase p38 beta inhibitor” CHEMBL1946170 ↗ |
| Modality | Small molecule | “Regorafenib is the first small-molecule multikinase inhibitor” PMID 23177514 ↗ Nov 2012 |
| Route | Oral | “Patients with previously untreated metastatic or unresectable clear-cell renal-cell carcinoma received oral regorafenib” PMID 22959186 ↗ Sep 2012 |
| Target | ABL1 | “Tyrosine-protein kinase ABL inhibitor” CHEMBL1946170 ↗ |
| Target | DDR2 | “Discoidin domain-containing receptor 2 inhibitor” CHEMBL1946170 ↗ |
| Target | EPHA2 | “Ephrin type-A receptor 2 inhibitor” CHEMBL1946170 ↗ |
| Target | FGFR2 | “Fibroblast growth factor receptor 2 inhibitor” CHEMBL1946170 ↗ |
| Target | FRK | “Tyrosine-protein kinase FRK inhibitor” CHEMBL1946170 ↗ |
| Target | KIT | “Regorafenib is a novel oral multikinase inhibitor of angiogenic (VEGFR1-3, TIE2), stromal (PDGFR-β, FGFR), and oncogenic kinases (KIT, RET, and RAF).” PMID 22421192 ↗ Mar 2012 |
| Target | MAPK11 | “MAP kinase p38 beta inhibitor” CHEMBL1946170 ↗ |
| Target | NTRK1 | “Nerve growth factor receptor Trk-A inhibitor” CHEMBL1946170 ↗ |
| Target | RET | “Regorafenib is a novel oral multikinase inhibitor of angiogenic (VEGFR1-3, TIE2), stromal (PDGFR-β, FGFR), and oncogenic kinases (KIT, RET, and RAF).” PMID 22421192 ↗ Mar 2012 |