Tivozanib
Small molecule targets KIT, PDGFRB via inhibition
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | FOTIVDA | — | 2021-03-10 | fda.gov ↗ |
| Approved | EU (EMA) | Fotivda | — | 2017-08-24 | europa.eu ↗ |
Trials 39 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 111 trials | ||||||
| Phase 1 | NCT01631097 | May 2012 → Jan 2014 | — | AVEO Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01363804 | May → Jul 2011 | — | AVEO Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01363778 | May → Jul 2011 | — | AVEO Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01316848 | Feb → May 2011 | — | AVEO Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01306630 | Nov 2010 → Jan 2014 | cancer | AVEO Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01210846 | Oct 2010 → Mar 2011 | cancer | AVEO Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00970411 | Aug 2009 → Apr 2016 | cancer | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00717340 | Feb 2009 → Jan 2011 | breast cancer | AVEO Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00826878 | Jan 2009 → Mar 2011 | non-small cell lung carcinoma | AVEO Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00660153 | Jun 2008 → Jun 2012 | colorectal cancer | AVEO Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00563147 | Nov 2007 → Nov 2010 | renal cell carcinoma | AVEO Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1/27 trials | ||||||
| Phase 1/2 | NCT04645160 | Mar 2022 → Dec 2028 expected | cholangiocarcinoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05000294 | Dec 2021 → Dec 2026 expected | bile duct cancer, breast cancer, gallbladder cancer, neuroendocrine neoplasm +5 | University of Florida | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03970616 | Sep 2019 → Apr 2023 | hepatocellular carcinoma | AVEO Pharmaceuticals, Inc. | Terminated | No outcome recorded |
| Phase 1/2 | NCT03136627 | Mar → Dec 2017 | renal cell carcinoma | AVEO Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT01728181 | Nov 2013 → Mar 2016 | non-small cell lung carcinoma | University of Utah | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT01835223 | Jul 2013 → Dec 2018 | adult hepatocellular carcinoma | Roswell Park Cancer Institute | Completed | No outcome recorded |
| Phase 1/2 | NCT01058655 | Feb 2010 → Sep 2013 | digestive system cancer | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 214 trials | ||||||
| Phase 2 | NCT07218692 | Aug 2026 → Aug 2027 expected | clear cell renal carcinoma, sarcomatoid renal cell carcinoma | City of Hope Medical Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06053658 | Jan 2024 → Nov 2026 expected | renal cell carcinoma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT01972516 | Nov 2013 → Jul 2015 | fallopian tube cancer, ovarian cancer, primary peritoneal carcinoma | Dana-Farber Cancer Institute | Terminated | No outcome recorded |
| Phase 2 | NCT01885949 | Sep 2013 → May 2024 | prostate cancer | Massachusetts General Hospital | Terminated | No outcome recorded |
| Phase 2 | NCT01853644 | Jun 2013 → Oct 2018 | fallopian tube cancer, malignant epithelial tumor of ovary, primary peritoneal carcinoma | Northwestern University | Completed | No outcome recorded |
| Phase 2 | NCT01846871 | Jun 2013 → Sep 2014 | glioblastoma | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 2 | NCT01834183 | Jun 2013 | renal cell carcinoma | Dana-Farber Cancer Institute | Withdrawn | No outcome recorded |
| Phase 2 | NCT01782313 | Mar 2013 → May 2015 | soft tissue sarcoma | Northwestern University | Completed | No outcome recorded |
| Phase 2 | NCT01807156 | Mar 2013 → Feb 2015 | hepatocellular carcinoma | Emory University | Terminated | No outcome recorded |
| Phase 2 | NCT01745367 | Nov 2012 → Jun 2014 | triple-negative breast carcinoma | AVEO Pharmaceuticals, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT01673386 | Jul 2012 → Jan 2014 | renal cell carcinoma | AVEO Pharmaceuticals, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT01478594 | Dec 2011 → Sep 2013 | colorectal cancer | AVEO Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01297244 | Jan 2011 → Oct 2012 | renal cell carcinoma | AVEO Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00502307 | Oct 2007 → Aug 2010 | renal cell carcinoma | AVEO Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT06661720 | Mar 2025 → Nov 2037 expected | clear cell renal carcinoma, renal pelvis carcinoma | Alliance for Clinical Trials in Oncology | Recruiting | No outcome recorded |
| Phase 3 | NCT04987203 | Sep 2021 → Jan 2026 | renal cell carcinoma | AVEO Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02627963 | May 2016 → Oct 2018 | renal cell carcinoma | AVEO Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01076010 | Mar 2010 → Jul 2014 | renal cell carcinoma | AVEO Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01030783 | Dec 2009 → Jul 2012 | renal cell carcinoma | AVEO Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT01769885 | Mar → Jun 2013 | renal cell carcinoma | Roswell Park Cancer Institute | Withdrawn | No outcome recorded |
| — | NCT01369433 | Jun 2010 → Jun 2015 | cancer | AVEO Pharmaceuticals, Inc. | Terminated | No outcome recorded |
Evidence & citations 19 cited values
Every value below carries the sentence it was read from. 42 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Tivozanib | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01076010 ↗37 |
| Known as | (tivozanib hydrochloride hydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1289494 ↗ |
| Known as | ASP-4130 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1289494 ↗ |
| Known as | AV-951 | “Thereafter in the Phase 1b and 2a study, subjects will receive tivozanib (AV-951) once daily for 3 weeks beginning on Day 1, followed by 1 week off treatment (1 cycle = 4 weeks).” NCT00717340 ↗8“This phase 2 trial is evaluating the antineoplastic activity of tivozanib (AV-951) in treating patients with recurrent or metastatic renal cell cancer.” NCT00502307 ↗ “The purpose of this study is to test the safety and tolerability of tivozanib (AV-951) and Torisel™ given in combination for renal cell cancer.” NCT00563147 ↗ “Subjects will receive 0.5 mg, 1.0 mg or 1.5 mg of tivozanib (AV-951) once daily for 3 weeks, followed by 1 week off.” NCT01369433 ↗ “Evaluating Efficacy of Tivozanib (AV-951) in Biliary Tract Cancers” NCT04645160 ↗ “Tivozanib (AV-951): 0.5 mg, 1.0 mg, and 1.5 mg oral once daily” NCT00660153 ↗ “Drug: Tivozanib (AV-951)” NCT00826878 ↗ “Drug: tivozanib (AV-951)” NCT01030783 ↗ “tivozanib (AV-951)” NCT01306630 ↗ |
| Known as | DC-001164TIVOZANIBAV9511-(2-CHLORO-4((6,7-DIMETHOXYQUINOLIN-4-YL)OXY)PHENYL)-3-(5-METHYLISOXAZO-3-YL)UREA | ChEMBL registry synonym — accepted as the source's own label CHEMBL1289494 ↗ |
| Known as | FOTIVDA | ChEMBL registry synonym — accepted as the source's own label CHEMBL1289494 ↗ |
| Known as | KIL-8951 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1289494 ↗ |
| Known as | KRN951 | “Tivozanib hydrochloride (tivozanib; previously known as AV-951 and as KRN951) has the chemical name” NCT03136627 ↗ |
| Known as | OPHTHOTECH | ChEMBL registry synonym — accepted as the source's own label CHEMBL1289494 ↗ |
| Known as | TIVOZANIB (AV-951) | ChEMBL registry synonym — accepted as the source's own label CHEMBL1289494 ↗ |
| Known as | TIVOZANIB (OPHTHALMIC) | ChEMBL registry synonym — accepted as the source's own label CHEMBL1289494 ↗ |
| Known as | TIVOZANIB HCL | ChEMBL registry synonym — accepted as the source's own label CHEMBL1289494 ↗ |
| Known as | Tivozanib hydrochloride | “Tivozanib hydrochloride (tivozanib) is a potent and selective tyrosine kinase inhibitor of all 3 vascular endothelial growth factor receptors with antitumor activity additive...” PMID 25591799 ↗ Dec 20142“Tivozanib hydrochloride (tivozanib; previously known as AV-951 and as KRN951) has the chemical name” NCT03136627 ↗ “Participants randomized to this arm will receive the study drug, tivozanib hydrochloride.” NCT02627963 ↗ |
| Known as | Tivozanib hydrochloride monohydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1289494 ↗ |
| Action | Inhibit | “Tivozanib (AV-951) is a VEGF-receptor tyrosine kinase inhibitor, and may stop the growth of tumor cells by blocking blood flow to the tumor.” NCT00502307 ↗2“Platelet-derived growth factor receptor beta inhibitor” CHEMBL1289494 ↗ “Stem cell growth factor receptor inhibitor” CHEMBL1289494 ↗ |
| Modality | Small molecule | “Tivozanib is a potent small molecule tyrosine kinase inhibitor against VEGFR1-3” PMID 27771610 ↗ Jan 2017 |
| Route | Oral | “solid oral dosage form taken daily for three weeks per one month cycle” NCT00502307 ↗ |
| Target | KIT | “Stem cell growth factor receptor inhibitor” CHEMBL1289494 ↗ |
| Target | PDGFRB | “Platelet-derived growth factor receptor beta inhibitor” CHEMBL1289494 ↗ |