Drugs / Axitinib
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | INLYTA | — | 2020-06-04 – 2022-09-22 | fda.gov ↗ |
| Approved | EU (EMA) | Inlyta | — | 2012-09-03 | europa.eu ↗ |
| Approved | US (FDA) | INLYTA | — | 2012-01-27 | fda.gov ↗ |
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05553782 | Nov 2023 → Apr 2029 expected | head and neck squamous cell carcinoma, salivary gland adenoid cystic carcinoma | Brigham and Women's Hospital | Recruiting | No outcome recorded |
| Phase 130 trials | ||||||
| Phase 1 | NCT06161558 | Jul 2025 | neoplasm | National Cancer Institute (NCI) | Withdrawn | No outcome recorded |
| Phase 1 | NCT06969001 | May → Sep 2025 | wet macular degeneration | SCAI Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT05904730 | Jul 2023 → Nov 2024 | HER2 positive breast carcinoma, Her2-receptor negative breast cancer, hereditary breast ovarian cancer syndrome, ovarian cancer | Lynkcell Europe | Completed | No outcome recorded |
| Phase 1 | NCT04873895 | Jan 2022 → Apr 2024 | colorectal cancer | Abramson Cancer Center at Penn Medicine | Terminated | No outcome recorded |
| Phase 1 | NCT05070221 | Oct 2021 → Oct 2023 | melanoma | Peking University Cancer Hospital & Institute | Unknown | No outcome recorded |
| Phase 1 | NCT04693468 | Dec 2020 → Dec 2027 expected | high grade malignant neoplasm, metastatic malignant neoplasm | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT04458259 | Sep 2020 → Nov 2024 | metastatic malignant neoplasm | Pfizer | Terminated | No outcome recorded |
| Phase 1 | NCT04540705 | Sep 2020 → Jan 2024 | renal cell carcinoma | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT04640545 | May 2020 → Aug 2024 | metastatic melanoma | Nanjing Leads Biolabs Co.,Ltd | Completed | No outcome recorded |
| Phase 1 | NCT03289533 | Sep 2017 → Aug 2019 | hepatocellular carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT02782403 | Mar 2017 → Nov 2019 | Philadelphia-positive myelogenous leukemia, blast phase chronic myelogenous leukemia, BCR-ABL1 positive, leukemia, myeloid, accelerated-phase | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 1 | NCT02814461 | Nov 2015 → Nov 2018 | hepatocellular carcinoma | Shin Kong Wu Ho-Su Memorial Hospital | Completed | No outcome recorded |
| Phase 1 | NCT02493751 | Oct 2015 → Apr 2018 | renal cell carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT02133742 | Sep 2014 → Mar 2017 | renal cell carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT02164838 | Sep 2014 → Oct 2017 | refractory malignant neoplasm | Children's Oncology Group | Completed | No outcome recorded |
| Phase 1 | NCT01999972 | Feb 2014 → Feb 2017 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01540526 | Mar 2012 → Sep 2014 | castration-resistant prostate carcinoma | University of Wisconsin, Madison | Completed | No outcome recorded |
| Phase 1 | NCT01441388 | Dec 2011 → Nov 2013 | glioblastoma, hepatocellular carcinoma, renal cell carcinoma | Pfizer | Withdrawn | No outcome recorded |
| Phase 1 | NCT01529138 | Oct 2011 → Mar 2014 | cancer | Emory University | Completed | No outcome recorded |
| Phase 1 | NCT01334073 | Mar 2011 → May 2013 | renal cell carcinoma | University Hospital, Bordeaux | Completed | No outcome recorded |
| Phase 1 | NCT00919204 | Aug 2009 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00918632 | Jun → Jul 2009 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00842244 | Apr → Dec 2009 | gastric cancer | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00859118 | Feb 2009 → May 2013 | neoplasm | University of Wisconsin, Madison | Completed | No outcome recorded |
| Phase 1 | NCT00726752 | Jul 2008 → Apr 2010 | neoplasm | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00692341 | May → Oct 2008 | liver disorder | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00447005 | Feb 2007 → Aug 2009 | carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00454649 | Dec 2005 → Aug 2009 | neoplasm | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00949624 | Dec 2005 → Jun 2008 | cancer | Arog Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01469052 | Nov 2002 → Jul 2004 | neoplasm | Pfizer | Completed | No outcome recorded |
| Phase 1/214 trials | ||||||
| Phase 1/2 | NCT07227415 | Feb 2026 → Nov 2027 expected | clear cell renal carcinoma | Pfizer | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06485908 | Oct 2024 → Apr 2026 overdue | ependymoma, medulloblastoma | Assistance Publique Hopitaux De Marseille | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT05808608 | Nov 2023 → Apr 2026 overdue | sarcomatoid renal cell carcinoma | Hao Zeng | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03481842 | Oct 2021 | endometriosis of intestine, ovarian endometriosis | BioGene Pharmaceutical Ltd. | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT04585815 | Nov 2020 → May 2023 | non-small cell lung carcinoma | Pfizer | Terminated | No outcome recorded |
| Phase 1/2 | NCT04337970 | Apr 2020 → May 2025 | renal cell carcinoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1/2 | NCT03386929 | Nov 2017 → Dec 2022 | non-small cell lung carcinoma | Worldwide Innovative Network Association | Terminated | No outcome recorded |
| Phase 1/2 | NCT03172754 | Jun 2017 → Nov 2026 expected | renal cell carcinoma | Fox Chase Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT02667886 | Apr 2016 → Apr 2022 | clear cell renal carcinoma | X4 Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/2 | NCT02535533 | Jan 2016 → Aug 2023 | clear cell renal carcinoma | Mohammed Milhem | Completed | No outcome recorded |
| Phase 1/2 | NCT01211275 | May 2009 → Nov 2012 | malignant pleural mesothelioma | The Netherlands Cancer Institute | Completed | No outcome recorded |
| Phase 1/2 | NCT00768755 | Jan 2009 → Mar 2011 | non-small cell lung carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 1/2 | NCT00460603 | Jan 2006 → Apr 2012 | colorectal neoplasm | Pfizer | Completed | No outcome recorded |
| Phase 1/2 | NCT00076024 | Feb 2004 → Jan 2007 | breast neoplasm | Pfizer | Completed | No outcome recorded |
| Phase 2106 trials | ||||||
| Phase 2 | NCT07607561 | Nov 2026 → Aug 2027 expected | wet macular degeneration | SCAI Therapeutics | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07469683 | Mar 2026 → Oct 2029 expected | clear cell renal carcinoma | Yonsei University | Recruiting | No outcome recorded |
| Phase 2 | NCT07277972 | Feb 2026 → Nov 2029 expected | clear cell renal carcinoma | Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07123090 | Nov 2025 → Oct 2026 expected | clear cell renal carcinoma | Stephanie Berg | Recruiting | No outcome recorded |
| Phase 2 | NCT07159191 | Sep 2025 → Feb 2027 expected | renal cell carcinoma | Peking Union Medical College Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07172386 | Jul 2025 → Jul 2026 overdue | renal cell carcinoma | Tianjin Medical University Second Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06962787 | Jul 2025 → May 2027 expected | kidney cancer | Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT06860386 | Feb 2025 → Sep 2026 | clear cell renal carcinoma | H. Lee Moffitt Cancer Center and Research Institute | Suspended | No outcome recorded |
| Phase 2 | NCT05176288 | May 2024 → Aug 2026 | clear cell renal carcinoma | Bradley A. McGregor, MD | Withdrawn | No outcome recorded |
| Phase 2 | NCT06279403 | Mar 2024 → Mar 2026 overdue | clear cell renal carcinoma | RenJi Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06211114 | Feb 2024 → Feb 2026 overdue | collecting duct carcinoma | Peking University Cancer Hospital & Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT05969496 | Dec 2023 → Nov 2026 expected | renal cell carcinoma | University of Colorado, Denver | Recruiting | No outcome recorded |
| Phase 2 | NCT05256472 | Jul 2023 → Dec 2025 | renal cell carcinoma | Akeso | Completed | No outcome recorded |
| Phase 2 | NCT05817903 | Apr 2023 → Apr 2026 overdue | renal cell carcinoma | Consorzio Oncotech | Recruiting | No outcome recorded |
| Phase 2 | NCT05768464 | Feb 2023 → Dec 2026 expected | renal cell carcinoma | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Recruiting | No outcome recorded |
| Phase 2 | NCT05327686 | Feb 2023 → Jun 2028 expected | renal cell adenocarcinoma | NRG Oncology | Recruiting | No outcome recorded |
| Phase 2 | NCT05249569 | Nov → Dec 2022 | hepatocellular carcinoma | University of Texas Southwestern Medical Center | Terminated | No outcome recorded |
| Phase 2 | NCT05420220 | Jul 2022 → Dec 2024 | non-small cell lung carcinoma | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Completed | No outcome recorded |
| Phase 2 | NCT05096390 | Jun 2022 → Oct 2024 | papillary renal cell carcinoma | Centre Leon Berard | Unknown | No outcome recorded |
| Phase 2 | NCT05263609 | Jun 2022 → Jun 2026 | renal cell carcinoma | University of Oklahoma | Withdrawn | No outcome recorded |
| Phase 2 | NCT05384496 | May 2022 → May 2027 expected | mucosal melanoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05097599 | Apr 2022 → Jun 2024 | cancer | Strata Oncology | Terminated | No outcome recorded |
| Phase 2 | NCT05172440 | Dec 2021 → Nov 2023 | — | Hongqian Guo | Unknown | No outcome recorded |
| Phase 2 | NCT04995016 | Aug 2021 → Aug 2022 | clear cell renal carcinoma | Tianjin Medical University Second Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04996823 | Aug 2021 → Aug 2026 overdue | melanoma | H. Lee Moffitt Cancer Center and Research Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT04958473 | Aug 2021 → Aug 2022 | clear cell renal carcinoma | Tianjin Medical University Second Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04387500 | Jul 2021 → Mar 2025 | inborn disorder of energy metabolism, renal cell carcinoma | West China Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04562441 | May 2021 → Oct 2024 | nasopharyngeal carcinoma | Chinese University of Hong Kong | Completed | No outcome recorded |
| Phase 2 | NCT04370509 | Feb 2021 → Feb 2025 | clear cell renal carcinoma | University of California, San Francisco | Terminated | No outcome recorded |
| Phase 2 | NCT04197219 | Feb 2021 → Jan 2025 | endometrial cancer | Case Comprehensive Cancer Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT04493203 | Dec 2020 → Apr 2024 | melanoma | Yana Najjar | Completed | No outcome recorded |
| Phase 2 | NCT04698213 | Oct 2020 → Sep 2023 | renal cell carcinoma | Consorzio Oncotech | Unknown | No outcome recorded |
| Phase 2 | NCT04459663 | Aug 2020 → Sep 2023 | non-small cell lung carcinoma | Li Zhang, MD | Unknown | No outcome recorded |
| Phase 2 | NCT04341181 | Aug 2020 → Apr 2029 expected | cancer | Ulrik Lassen | Recruiting | No outcome recorded |
| Phase 2 | NCT04385654 | Jun 2020 → Dec 2021 | kidney cancer | West China Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04010071 | May 2020 → Jan 2024 | biliary tract neoplasm, liver cancer | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04118855 | Mar 2020 → Feb 2023 | renal cell adenocarcinoma | RenJi Hospital | Completed | No outcome recorded |
| Phase 2 | NCT04180995 | Aug 2019 → Jul 2022 | mucosal melanoma | Peking University Cancer Hospital & Institute | Unknown | No outcome recorded |
| Phase 2 | NCT03990571 | Jul 2019 → Mar 2023 | adenoid cystic carcinoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT04258956 | Apr 2019 → Apr 2021 | gastrointestinal stromal tumor | Maria Sklodowska-Curie National Research Institute of Oncology | Completed | No outcome recorded |
| Phase 2 | NCT03839498 | Jan 2019 → Jan 2027 expected | paraganglioma, pheochromocytoma | Columbia University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03595124 | Jan 2019 → Sep 2024 overdue | renal cell carcinoma associated with Xp11.2 translocations/TFE3 gene fusions | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06889649 | Jan 2019 → Feb 2027 expected | renal cell carcinoma | Peking University First Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT03736330 | Sep 2018 → Oct 2020 | renal cell carcinoma | Sun Yat-sen University | Unknown | No outcome recorded |
| Phase 2 | NCT03472560 | May 2018 → Feb 2023 | non-small cell lung carcinoma, urothelial carcinoma | Pfizer | Terminated | No outcome recorded |
| Phase 2 | NCT03341845 | Mar 2018 → Jan 2023 | renal cell carcinoma | The Netherlands Cancer Institute | Unknown | 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 | NCT03438708 | Mar 2018 → Mar 2026 overdue | clear cell renal carcinoma | University of California, San Diego | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03494816 | Dec 2017 → Mar 2020 | renal cell carcinoma | Scottish Clinical Trials Research Unit | Completed | No outcome recorded |
| Phase 2 | NCT03592199 | Dec 2017 → Dec 2019 | clear cell renal carcinoma | Cancer Institute of the State of São Paulo | Unknown | No outcome recorded |
| Phase 2 | NCT03092856 | Jul 2017 → Dec 2026 expected | clear cell renal carcinoma | University of Southern California | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03291314 | May 2017 → Jan 2019 | glioblastoma | University Hospital Brussels | 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 | NCT02912572 | Nov 2016 → Nov 2023 overdue | endometrial cancer | Dana-Farber Cancer Institute | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02859012 | Sep 2016 → Dec 2017 | carcinoma | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT02762513 | Aug 2016 → Apr 2020 | head and neck squamous cell carcinoma | University of Michigan Rogel Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT02925234 | Aug 2016 → Sep 2027 expected | cancer | The Netherlands Cancer Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT02636725 | Apr 2016 → May 2018 | alveolar soft part sarcoma | Jonathan Trent, MD, PhD | Completed | No outcome recorded |
| Phase 2 | NCT02560012 | Jan 2016 → Jul 2017 | renal cell carcinoma | The University of Texas Health Science Center, Houston | Terminated | No outcome recorded |
| Phase 2 | NCT02700568 | Jan 2016 → Jun 2018 | clear cell renal carcinoma | Kidney Cancer Research Bureau | Completed | No outcome recorded |
| Phase 2 | NCT02579811 | Dec 2015 → Aug 2019 | renal cell carcinoma | Case Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT02638428 | Dec 2015 → Dec 2021 | childhood acute myeloid leukemia | Samsung Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT02489695 | Oct 2015 → Jul 2019 | papillary renal cell carcinoma | Centre Leon Berard | Completed | No outcome recorded |
| Phase 2 | NCT02857712 | Dec 2014 → Oct 2018 | salivary gland cancer | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | Completed | No outcome recorded |
| Phase 2 | NCT02261207 | Nov 2014 → Oct 2017 | solitary fibrous tumor | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | Completed | No outcome recorded |
| Phase 2 | NCT01562197 | Apr 2014 → Aug 2018 | glioblastoma | Bart Neyns | Completed | No outcome recorded |
| Phase 2 | NCT02129647 | Apr 2014 → Feb 2019 | NF2-related schwannomatosis, acoustic neuroma | NYU Langone Health | Completed | No outcome recorded |
| Phase 2 | NCT01967576 | Oct 2013 → Jun 2015 | paraganglioma, pheochromocytoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT01798446 | Feb 2013 → Jun 2015 | renal cell carcinoma | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT01693822 | Oct 2012 → Mar 2017 | clear cell renal carcinoma | Institute of Cancer Research, United Kingdom | Completed | No outcome recorded |
| Phase 2 | NCT04355156 | Sep 2012 → Feb 2019 | colorectal cancer | Imperial College London | Completed | No outcome recorded |
| Phase 2 | NCT01649180 | Jul 2012 → Jan 2016 | renal cell carcinoma | PrECOG, LLC. | Terminated | No outcome recorded |
| Phase 2 | NCT01409200 | Mar 2012 → Feb 2026 | metastatic malignant neoplasm in the lymph nodes, prostate adenocarcinoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT01558661 | Mar 2012 → Aug 2016 | adenoid cystic carcinoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT02597322 | Feb 2012 → Nov 2015 | kidney neoplasm | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 2 | NCT01483638 | Feb 2012 → Sep 2015 | colorectal carcinoma | Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) | Terminated | No outcome recorded |
| Phase 2 | NCT01469546 | Jan 2012 → Apr 2015 | head and neck squamous cell carcinoma | University of Michigan Rogel Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT01533948 | Jan 2012 → Jul 2015 | ocular melanoma with extraocular extension, uveal melanoma | Roswell Park Cancer Institute | Terminated | No outcome recorded |
| Phase 2 | NCT01490866 | Jan 2012 → Jul 2015 | colorectal cancer | SCRI Development Innovations, LLC | Completed | No outcome recorded |
| Phase 2 | NCT01321437 | Dec 2011 → Dec 2016 | melanoma | University of California, Irvine | Completed | No outcome recorded |
| Phase 2 | NCT01385059 | Oct 2011 → Oct 2013 | prostate cancer | City of Hope Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT01435122 | Oct 2011 → Jan 2017 | carcinoid tumor | H. Lee Moffitt Cancer Center and Research Institute | Completed | No outcome recorded |
| Phase 2 | NCT01508117 | Aug 2011 → Oct 2012 | glioblastoma | University of Cincinnati | Terminated | No outcome recorded |
| Phase 2 | NCT01352728 | May 2011 → Jun 2018 | hepatocellular carcinoma | Chinese University of Hong Kong | Completed | No outcome recorded |
| Phase 2 | NCT01273662 | Apr 2011 → Mar 2016 | hepatocellular carcinoma | National Taiwan University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT01263769 | Feb 2011 → Feb 2021 | kidney cancer | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT01334112 | Jan 2011 → Mar 2018 | hepatocellular carcinoma | University Health Network, Toronto | Completed | No outcome recorded |
| Phase 2 | NCT01210495 | Dec 2010 → Mar 2014 | hepatocellular carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT01249547 | Dec 2010 → Dec 2016 | nasopharyngeal carcinoma | Chinese University of Hong Kong | Completed | No outcome recorded |
| Phase 2 | NCT01255137 | Sep 2010 → Dec 2012 | adrenal cortex neoplasm | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT01140737 | Aug 2010 → Jun 2016 | soft tissue sarcoma | Sheffield Teaching Hospitals NHS Foundation Trust | Completed | No outcome recorded |
| Phase 2 | NCT01174238 | Jul 2010 → Aug 2013 | melanoma | Adil Daud | Completed | No outcome recorded |
| Phase 2 | NCT00835978 | Aug 2009 → Oct 2012 | renal cell carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00735904 | Dec 2008 → Nov 2011 | non-small cell lung carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00600821 | Apr 2008 → Apr 2011 | adenocarcinoma, non-small cell lung carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00615056 | Mar 2008 → Mar 2011 | colorectal cancer | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00569946 | Dec 2007 → Feb 2010 | renal cell carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00386555 | May 2007 → ? | non-small cell lung carcinoma | Arog Pharmaceuticals, Inc. | Withdrawn | No outcome recorded |
| Phase 2 | NCT00389441 | Dec 2006 → Sep 2012 | thyroid tumor | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00282048 | Mar 2006 → Feb 2009 | renal cell carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00219557 | Jul 2005 → Mar 2008 | malignant pancreatic neoplasm | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00094094 | Feb 2005 → Jul 2007 | non-small cell lung carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00094107 | Dec 2004 → Apr 2008 | melanoma, skin neoplasm | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00094055 | Sep 2004 → Jan 2009 | thyroid tumor | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00076011 | Oct 2003 → Feb 2007 | kidney neoplasm | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00071006 | Sep 2003 → Jul 2004 | acute myeloid leukemia, myelodysplastic syndrome | Pfizer | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT06020352 | Aug 2023 → Jul 2025 | non-small cell lung carcinoma | Shanghai Pulmonary Hospital, Shanghai, China | Unknown | No outcome recorded |
| Phase 2/3 | NCT01744249 | Nov 2011 → Dec 2023 | neuroendocrine neoplasm | Spanish Group for Research in Neuroendocrine Tumors | Completed | No outcome recorded |
| Phase 314 trials | ||||||
| Phase 3 | NCT07516132 | Apr 2026 → Aug 2030 expected | age-related macular degeneration | Ocular Therapeutix, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT07235085 | Nov 2025 → Mar 2027 expected | diabetic retinopathy | Ocular Therapeutix, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT06495918 | Nov 2024 → Jan 2027 expected | wet macular degeneration | Ocular Therapeutix, Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06364631 | Apr 2024 → May 2032 expected | clear cell renal carcinoma | Gustave Roussy, Cancer Campus, Grand Paris | Recruiting | No outcome recorded |
| Phase 3 | NCT06223958 | Jan 2024 → Apr 2026 overdue | wet macular degeneration | Ocular Therapeutix, Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05738694 | Apr 2023 → Dec 2027 expected | renal cell carcinoma | ZHOU FANGJIAN | Recruiting | No outcome recorded |
| Phase 3 | NCT05059522 | Sep 2021 → Dec 2026 expected | non-small cell lung carcinoma, ovarian cancer, urothelial carcinoma | Pfizer | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04394975 | Aug 2020 → Apr 2024 | renal cell adenocarcinoma | Shanghai Junshi Bioscience Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT02853331 | Sep 2016 → Oct 2018 | renal cell carcinoma | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT02684006 | Mar 2016 → Aug 2023 | renal cell carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT01599754 | Apr 2012 → Oct 2017 | clear cell renal carcinoma | SFJ Pharma Ltd. II | Terminated | No outcome recorded |
| Phase 3 | NCT00920816 | Aug 2009 → Jul 2012 | kidney neoplasm | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00678392 | Sep 2008 → Aug 2010 | renal carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00471146 | Jul 2007 → Jan 2009 | pancreatic ductal adenocarcinoma | Pfizer | Completed | No outcome recorded |
| Phase not applicable5 trials | ||||||
| — | NCT05816642 | Aug 2022 → Dec 2023 | renal cell carcinoma | RenJi Hospital | Unknown | No outcome recorded |
| — | NCT03826589 | Jun 2019 → Mar 2024 | cervical cancer | The University of Hong Kong | Completed | No outcome recorded |
| — | NCT02551718 | Sep 2015 → Jun 2020 | acute leukemia of ambiguous lineage, acute lymphoblastic leukemia | University of Washington | Completed | No outcome recorded |
| — | NCT01486251 | Sep 2011 → Apr 2013 | colorectal carcinoma | Gustave Roussy, Cancer Campus, Grand Paris | Completed | No outcome recorded |
| — | NCT00828919 | Mar 2003 → Aug 2023 | cancer | Pfizer | Completed | No outcome recorded |
| Phase not stated2 trials | ||||||
| — | NCT01473043 | Mar 2012 → Mar 2014 | renal cell carcinoma | Pfizer | No longer available | No outcome recorded |
| — | NCT05941637 | — | clear cell renal carcinoma | Lynkcell Europe | No longer available | No outcome recorded |
Also used as a comparator or background therapy in 23 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT06424626 Background | May 2024 → Dec 2027 expected | metastatic melanoma, mucosal melanoma | Peking University Cancer Hospital & Institute | Enrolling by invitation | No outcome recorded |
| Phase 1 | NCT05695417 Comparator | Jan 2023 → Jan 2024 | severe nonproliferative diabetic retinopathy | Ocular Therapeutix, Inc. | Unknown | No outcome recorded |
| Phase 1 | NCT05017012 Background | Sep 2021 → May 2026 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT04522323 Background | Aug 2020 → Sep 2025 overdue | renal cell carcinoma | MedImmune LLC | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03275558 Comparator | Jul 2018 | gliosarcoma | Center Trials & Treatment | Withdrawn | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT07630363 Background | May 2026 → Mar 2028 expected | clear cell renal carcinoma | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT05949632 Background | Apr 2024 → Jun 2025 | cancer | Incyte Corporation | Terminated | No outcome recorded |
| Phase 1/2 | NCT05363631 Background | Sep 2022 → Dec 2026 expected | clear cell renal carcinoma | Mohammed Milhem | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT01806064 Comparator | Mar 2013 → Dec 2018 | renal cell carcinoma | Tracon Pharmaceuticals Inc. | Terminated | No outcome recorded |
| Phase 27 trials | ||||||
| Phase 2 | NCT06690697 Comparator | Jun 2024 → Jun 2026 overdue | clear cell renal carcinoma | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT05805501 Background | Apr 2023 → Oct 2026 expected | renal cell carcinoma | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03941795 Comparator | Nov 2019 → Jun 2022 | mucosal melanoma | Peking University Cancer Hospital & Institute | Unknown | No outcome recorded |
| Phase 2 | NCT02639182 Comparator | May 2016 → Oct 2020 | renal cell carcinoma | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02187302 Comparator | Jul 2014 → Jul 2016 | renal cell carcinoma | NewLink Genetics Corporation | Completed | No outcome recorded |
| Phase 2 | NCT01727336 Background | Dec 2012 → Jun 2017 | renal cell carcinoma | Acceleron Pharma, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT01441414 Comparator | Nov 2011 → Mar 2014 | renal cell carcinoma | Pfizer | Terminated | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT05522231 Comparator | Oct 2022 → Jan 2025 overdue | renal cell carcinoma | Hutchmed | Active not recruiting | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT07383441 Background | Jun 2026 → Jan 2033 expected | clear cell renal carcinoma | SWOG Cancer Research Network | Recruiting | No outcome recorded |
| Phase 3 | NCT06726421 Background | Sep 2024 → Sep 2030 expected | renal cell carcinoma | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 3 | NCT04510597 Comparator | Mar 2021 → Jul 2033 expected | clear cell renal carcinoma | SWOG Cancer Research Network | Recruiting | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT06903312 Comparator | Jun 2025 → Oct 2027 expected | renal cell carcinoma | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT07500831 Background | Apr 2026 → Apr 2028 expected | renal cell carcinoma | Qilu Hospital of Shandong University | Not yet recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT02354612 Background | — | cancer | Tracon Pharmaceuticals Inc. | No longer available | No outcome recorded |
Press releases naming this drug 11 releases
| Date | Issuer | Release |
|---|---|---|
| 2019-10-28 | Pfizer | European Commission Approves BAVENCIO® (avelumab) Plus Axitinib Combination for First-Line Treatment of Patients With Advanced Renal Cell Carcinoma pfizer.com ↗ |
| 2019-09-20 | Pfizer | CHMP Adopts Positive Opinion for BAVENCIO® (avelumab) Plus Axitinib for First-Line Treatment of Patients with Advanced Renal Cell Carcinoma pfizer.com ↗ |
| 2019-05-14 | Pfizer | FDA Approves BAVENCIO® (avelumab) Plus INLYTA® (axitinib) Combination for Patients with Advanced Renal Cell Carcinoma pfizer.com ↗ |
| 2019-03-08 | Pfizer | European Medicines Agency Validates Application for BAVENCIO® (avelumab) Plus INLYTA® (axitinib) for the Treatment of Advanced Renal Cell Carcinoma pfizer.com ↗ |
| 2019-02-16 | Pfizer | Pivotal Phase III Data for BAVENCIO® (avelumab) Plus INLYTA® (axitinib) in Advanced Renal Cell Carcinoma Published in The New England Journal of Medicine pfizer.com ↗ |
| 2019-02-11 | Pfizer | FDA Accepts sBLA and Grants Priority Review for BAVENCIO® (avelumab) Plus INLYTA® (axitinib) for the Treatment of Advanced Renal Cell Carcinoma pfizer.com ↗ |
| 2018-09-11 | Pfizer | BAVENCIO® (avelumab) Plus INLYTA® (axitinib) Significantly Improved Progression-Free Survival in Previously Untreated Patients with Advanced Renal Cell Carcinoma in Phase III Study pfizer.com ↗ |
| 2018-04-10 | Pfizer | Pfizer Provides Update on Phase 3 Trial of Axitinib as Adjuvant Treatment for Patients at High Risk of Renal Cell Carcinoma Recurrence After Surgery pfizer.com ↗ |
| 2017-12-21 | Pfizer | FDA Grants Breakthrough Therapy Designation for Avelumab in Combination with INLYTA® in Advanced Renal Cell Carcinoma pfizer.com ↗ |
| 2016-10-09 | Pfizer | Pfizer Presents Promising New Immunotherapy Combination Data With INLYTA® (axitinib) In Advanced Renal Cell Carcinoma (RCC) pfizer.com ↗ |
| 2016-04-05 | Pfizer | Merck and Pfizer Announce First Patient Treated in Phase III Combination Study with Avelumab and INLYTA® in Renal Cell Carcinom pfizer.com ↗ |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 198 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | axitinib | “Drugs may include all or a subset of the following which each may be tested as single agents or in any number of combinations including, but not limited to: Lenvatinib,...” NCT05553782 ↗190“Medical therapy is the continuation of the immune-based combo for mRCC including one of the available options among axitinib + pembrolizumab or cabozantinib + nivolumab or...” NCT06903312 ↗ “Axitinib, a potent and selective second-generation inhibitor of vascular endothelial growth factor receptors, has shown activity in advanced thyroid cancer in a Phase II study.” PMID 25315258 ↗ Oct 2014 “Axitinib (AG-013736) is a potent and selective oral inhibitor of vascular endothelial growth factor receptors 1, 2, and 3, which have an important role in pancreatic cancer.” PMID 18514303 ↗ May 2008 “Within the SOC arm, patients received single-agent bevacizumab (19), axitinib (18), everolimus (7), pazopanib (4), sorafenib (4), sunitinib (2), or temsirolimus (2).” PMID 28950297 ↗ Nov 2017 “To assess the single-dose and multiple-dose pharmacokinetics (PK), safety and tolerability of SCAI-005 eyedrops(axitinib) in healthy volunteers” NCT06969001 ↗ “BACKGROUND: Axitinib (AG-013736) is an oral, selective and potent inhibitor of vascular endothelial growth factor receptors (VEGFR)-1, 2 and 3.” PMID 21889330 ↗ Aug 2011 “AG-013736 (axitinib) is available as 1mg, and 5 mg film-coated tablets for oral administration- The starting dose is 5 mg BID-” NCT00600821 ↗ “Axitinib (AG-013736) is an oral, potent, and selective inhibitor of vascular endothelial growth factor receptors 1, 2, and 3.” PMID 17959415 ↗ Oct 2007 “Axitinib continuous oral dosing (10 mg once a day, 10 mg twice a day, 20 mg twice a day or 30 mg twice day) in the fed state” NCT01469052 ↗ “Drug: Axitinib 5mg orally twice a day Combination Treatment：Anti-PD-1 Combinations of D-CIK Immunotherapy” NCT03736330 ↗ “Sintilimab Plus Axitinib for Advanced Fumarate Hydratase-Deficient Renal Cell” PMID 40810951 ↗ Oct 2025 “Asparaginase Escherichia coli source, Axitinib, Azacitidine” NCT02788201 ↗ “1st Line Sunitinib and 2nd Line Axitinib” NCT03592199 ↗ “Intravitreal OTX-TKI (Axitinib Implant)” NCT06495918 ↗ “Arsenic trioxide Axitinib Azacitidine” NCT02551718 ↗ “Axitinib 5 mg oral Daily BID” NCT04510597 ↗ “OTX-TKI (Axitinib Implant)” NCT07516132 ↗ “OTX-TKI (Axitinib Implant)” NCT05695417 ↗ “AG-013736 (axitinib)” NCT00076024 ↗ “AG-013736 (AXITINIB)” NCT01558661 ↗ “AG-013736 (axitinib)” NCT00282048 ↗ “AG-013736 (axitinib)” NCT00460603 ↗ “AG-013736 (axitinib)” NCT00919204 ↗ “Axitinib 0.084mg/day” NCT07607561 ↗ “Axitinib” NCT03592199 ↗ “Axitinib” NCT00859118 ↗ |
| Known as | A-013736 | “A-013736 (Axitinib) is a selective inhibitor of vascular endothelial growth factor (VEGF) receptors 1, 2 and 3, and is therefore classed as an angiogenesis inhibitor with VEGF...” NCT04355156 ↗ |
| Known as | AG013736 | “Axitinib (AG-013736; Pfizer) is a multi-targeted small-molecule inhibitor of the receptor tyrosine kinases involved in tumor proliferation and angiogenesis, including VEGFR-1,...” NCT02859012 ↗44“A PHASE 1B, OPEN LABEL, DOSE FINDING STUDY TO EVALUATE SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF AXITINIB (AG-013736) IN COMBINATION WITH PEMBROLIZUMAB (MK-3475) IN...” NCT02133742 ↗ “Axitinib (AG-013736) is a potent and selective oral inhibitor of vascular endothelial growth factor receptors 1, 2, and 3, which have an important role in pancreatic cancer.” PMID 18514303 ↗ May 2008 “Axitinib (AG-013736, Pfizer Inc.), a receptor-tyrosine kinase inhibitor that is selective for VEGFR1, 2, and 3, is an important new agent for use in metastatic RCC.” NCT01649180 ↗ “BACKGROUND: Axitinib (AG-013736) is an oral, selective and potent inhibitor of vascular endothelial growth factor receptors (VEGFR)-1, 2 and 3.” PMID 21889330 ↗ Aug 2011 “Axitinib (AG-013736) is an oral, potent and selective inhibitor of vascular endothelial growth factor (VEGF) receptors 1, 2, and 3.” NCT01967576 ↗ “Axitinib (AG-013736) is an oral, potent and selective inhibitor of vascular endothelial growth factor (VEGF) receptors 1, 2, and 3.” NCT01255137 ↗ “Axitinib (AG-013736) is an oral, potent and selective inhibitor of vascular endothelial growth factor (VEGF) receptors 1, 2, and 3.” NCT03839498 ↗ “Effect of axitinib (AG-013736) on fatigue, thyroid-stimulating hormone, and biomarkers: a phase I study in Japanese patients.” PMID 20180805 ↗ Dec 2009 “Axitinib (AG-013736) is an oral, potent, and selective inhibitor of vascular endothelial growth factor receptors 1, 2, and 3.” PMID 17959415 ↗ Oct 2007 “Axitinib (AG-013736) tablet administered orally at a dose of 5 milligrams (mg) twice daily (BID) in cycles of 4 weeks.” NCT00094094 ↗ “To test the maximum tolerated dose of avelumab (MSB0010718C) in combination with axitinib (AG-013736)” NCT02493751 ↗ “Axitinib (AG-013736) With Or Without Dose Titration (Increase) In Patients With Kidney Cancer” NCT00835978 ↗ “Axitinib (AG013736; trade name Inlyta) is a small molecule tyrosine kinase inhibitor.” NCT04493203 ↗ “The starting dose of axitinib (AG-013736) is 5 mg BID administered orally with food.” NCT01562197 ↗ “continuation of axitinib (AG 013736) treatment” NCT00828919 ↗ “Axitinib (AG-013736) 5 mg tablet orally BID” NCT00454649 ↗ “AG-013736 (AXITINIB)” NCT01558661 ↗ “Axitinib (AG-013736)” NCT03472560 ↗ “AG-013736 (Axitinib)” NCT00071006 ↗ “Axitinib (AG-013736)” NCT00920816 ↗ “Axitinib [AG-013736]” NCT00094107 ↗ “Axitinib (AG-013736)” NCT02684006 ↗ “Axitinib (AG-013736)” NCT01334112 ↗ “Axitinib (AG-013736)” NCT00726752 ↗ “Axitinib (AG-013736)” NCT01441414 ↗ “Axitinib (AG-013736)” NCT01210495 ↗ “Axitinib (AG-013736)” NCT03289533 ↗ “Axitinib (AG-013736)” NCT00678392 ↗ “Axitinib (AG-013736)” NCT01469546 ↗ “AG-013736 (axitinib)” NCT00615056 ↗ |
| Known as | Inlyta | “This arm of the Strata PATH trial will assess the clinical benefit of Inlyta® (axitinib) in patients with advanced solid tumors and are Angiogensis Inhibitor Treatment Response...” NCT05097599 ↗5“Axitinib (Inlyta, Pfizer Inc.) is a novel oral angiogenesis inhibitor that selectively targets vascular endothelial growth factor (VEGFR) 1, 2 and 3.” NCT04010071 ↗ “Axitinib (Inlyta®) PO, in the morning and in the evening every day” NCT06485908 ↗ “TORIPALIMAB INJECTION(JS001 ) Axitinib tablet (Inlyta®)” NCT04180995 ↗ “Axitinib Oral Tablet [Inlyta]” NCT05096390 ↗ “Axitinib 1 MG [Inlyta]” NCT03941795 ↗ |
| Known as | Inritar | “1. Axitinib (Inritar)” NCT07630363 ↗ |
| Known as | OTX-TKI | “Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age- Related Macular Degeneration” NCT06495918 ↗3“Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age-Related Macular Degeneration” NCT06223958 ↗ “Intravitreal OTXTKI (Axitinib Implant) in Participants With Non-Proliferative Diabetic Retinopathy” NCT07235085 ↗ “OTX-TKI (Axitinib Implant)” NCT05695417 ↗ |
| Action | Inhibit | “selective inhibitor of vascular endothelial growth factor receptors 1, 2, and 3” PMID 17959415 ↗ Oct 2007 |
| Modality | Small molecule | “axitinib, a small molecule tyrosine kinase inhibitor (TKI)” NCT02667886 ↗ |
| Route | Oral | “received axitinib orally” PMID 17959415 ↗ Oct 2007 |
| Target | KDR | “Tyrosine Kinase Inhibitor Of VEGFR-2” NCT01469052 ↗ |