Drugs / Tivozanib
last change Aug 2026 re-read 8 days ago

Tivozanib

Small molecule targets KIT, PDGFRB via inhibition

Developed for
renal cell carcinoma · cancer · breast cancer · clear cell renal carcinoma · colorectal cancer · fallopian tube cancer · hepatocellular carcinoma · non-small cell lung carcinoma
+16 more · ovarian cancer · primary peritoneal carcinoma · prostate cancer · soft tissue sarcoma · adult hepatocellular carcinoma · bile duct cancer · cholangiocarcinoma · digestive system cancer · gallbladder cancer · glioblastoma · malignant epithelial tumor of ovary · neuroendocrine neoplasm · pancreatic adenocarcinoma · renal pelvis carcinoma · triple-negative breast carcinoma · vulva cancer
Investigated by
AVEO Pharmaceuticals, Inc. · National Comprehensive Cancer Network · Dana-Farber Cancer Institute · Massachusetts General Hospital · National Cancer Institute (NCI) · Astellas Pharma Inc
+17 more · Bristol-Myers Squibb · Northwestern University · Roswell Park Cancer Institute · Alliance for Clinical Trials in Oncology · AstraZeneca · Aveo Oncology Pharmaceuticals · Beth Israel Deaconess Medical Center · Brigham and Women's Hospital · City of Hope Medical Center · Emory University · Genentech, Inc. · Kyowa Kirin, Inc. · M.D. Anderson Cancer Center · Novartis · Parexel · University of Florida · University of Utah

Regulatory milestones approvals, filings & regulatory actions · 6 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed renal cell adenocarcinoma 4 milestones
Filed US (FDA) — renal cell adenocarcinoma 2020-03-31

“today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tivozanib” aveooncology.com ↗

Filed EU (EMA) — renal cell adenocarcinoma 2016-03-01

“today announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency for tivozanib for the first-line treatment of advanced renal cell...” aveooncology.com ↗

Rejected (CRL) US (FDA) — renal cell adenocarcinoma 2013-06-10

“AVEO Announces Complete Response Letter Received for Tivozanib New Drug Application in Renal Cell Carcinoma” aveooncology.com ↗

Filed US (FDA) TIVOPATH renal cell adenocarcinoma 2012-09-28

“AVEO and Astellas announced that the FDA accepted for filing the NDA for tivozanib with the proposed indication for the treatment of patients with advanced RCC” aveooncology.com ↗

“In June 2020, AVEO announced that the FDA accepted for filing its NDA seeking approval for tivozanib as a treatment for relapsed or refractory RCC.” aveooncology.com ↗

“AVEO submitted a New Drug Application to the U.S. Food and Drug Administration seeking approval for tivozanib in patients with advanced RCC.” aveooncology.com ↗

“AVEO has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for tivozanib” astellas.com ↗

“the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for tivozanib” astellas.com ↗

“the tivozanib New Drug Application (NDA), which was submitted by AVEO on September 28, 2012” astellas.com ↗

Approved Indication not stated 2 milestones
Approved US (FDA) FOTIVDA — 2021-03-10 fda.gov ↗
Approved EU (EMA) Fotivda — 2017-08-24 europa.eu ↗

Trials 39

PhaseRegistry idDatesIndicationSponsorStatusOutcome
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 1/27 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 Stop: Enrollment
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 · 1 missed
Phase 2 NCT07218692 Aug 2026 → Aug 2027 clear cell renal carcinoma, sarcomatoid renal cell carcinoma City of Hope Medical Center Withdrawn No outcome recorded
Phase 2 NCT06053658 Jan 2024 → Nov 2028 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 Stop: Enrollment
Phase 2 NCT01885949 Sep 2013 → May 2024 prostate cancer Massachusetts General Hospital Terminated No outcome recorded Stop: Enrollment
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 Stop: Enrollment
Phase 35 trials · 2 met primary · 1 missed
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 Missed primary
Phase 3 NCT02627963 May 2016 → Oct 2018 renal cell carcinoma AVEO Pharmaceuticals, Inc. Completed Met primary
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 Met primary
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

News releases announcing trial results or a regulatory action · 82

DateIssuerRelease
2025-06-03 AVEO Pharmaceuticals, Inc. Results AVEO Oncology, an LG Chem company, Presents Three Posters at ASCO 2025 Annual Meeting aveooncology.com ↗
AVEO presented data from an exploratory sub-analysis of the TiNivo-2 study, evaluating the efficacy of tivozanib as a 2 nd line treatment option in patients who failed 1 st line vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) and immune
2025-02-18 AVEO Pharmaceuticals, Inc. Results AVEO Oncology, an LG Chem company, Presents Two Posters for Tivozanib at the 2025 ASCO GU Meeting aveooncology.com ↗
Cumulative data of three Phase 3 studies demonstrate greater exposure of tivozanib is associated with increased clinical benefit
2024-09-16 AVEO Pharmaceuticals, Inc. Results AVEO Oncology, an LG Chem company, Present TiNivo-2 Results and TIVO-3 Exploratory Post Immunotherapy Survival Analysis at ESMO 2024 aveooncology.com ↗
Additionally, a follow up exploratory analysis from TIVO-3, FOTIVDA’s pivotal trial, was also presented during the conference.
2024-07-18 AVEO Pharmaceuticals, Inc. Results AVEO Oncology, an LG Chem company, Announces Phase 3 Renal Cell Carcinoma Clinical Trial (TiNivo-2) Results aveooncology.com ↗
The addition of nivolumab to low dose tivozanib after prior immune checkpoint inhibitor (ICI) is not superior to standard dose tivozanib alone; as a result, the primary endpoint was not met
2024-02-06 AVEO Pharmaceuticals, Inc. Results AVEO Oncology Announces Publication of Long-Term Survival in Patients With Relapsed/Refractory Advanced Renal Cell Carcinoma Treated With Tivozanib: Analysis of the Phase III TIVO-3 Trial in The Oncologist aveooncology.com ↗
In the publication, FOTIVDA demonstrated a consistent safety profile and a long-term survival benefit in patients who were alive and progression-free at 12 months, suggesting a durable clinical benefit and safety across age groups regardless of prior treatment.
2022-06-06 AVEO Pharmaceuticals, Inc. Results AVEO Oncology Presents Three Posters for Tivozanib at the 2022 ASCO Annual Meeting aveooncology.com ↗
Exploratory long-term OS analyses of TIVO-3 continue to trend in favor of tivozanib, patients with PFS at 1 year demonstrated a 55% reduction in risk of death on tivozanib as compared to sorafenib
2022-02-14 AVEO Pharmaceuticals, Inc. Results AVEO Oncology to Present Positive New Long-Term PFS Data from Phase 3 TIVO-3 Study of FOTIVDA® (tivozanib) in Third- and Fourth-Line Renal Cell Carcinoma aveooncology.com ↗
We are excited to report that the five year follow-up data announced today show that patients receiving FOTIVDA are up to five times more likely to experience long-term progression free survival as compared to sorafenib.
2022-01-20 AVEO Pharmaceuticals, Inc. Results AVEO Oncology Presents Three Posters for Tivozanib/Immunotherapy Combinations at the 2022 ASCO GI Cancers Symposium aveooncology.com ↗
First line cohort of the Phase 1b/2 DEDUCTIVE study demonstrates promising efficacy and tolerability of tivozanib plus durvalumab in first line HCC
2021-05-19 AVEO Pharmaceuticals, Inc. Results AVEO Oncology Announces Presentation of Long-Term Efficacy Follow Up, Additional Tolerability Data from the Phase 3 TIVO-3 Study of FOTIVDA® (tivozanib) in Relapsed or Refractory Renal Cell Carcinoma aveooncology.com ↗
Patients Treated with Tivozanib in TIVO-3 Study Demonstrated Over 20 Months Median DOR; OS Relative to Sorafenib Continues to Improve with Longer Follow-up
2021-03-10 AVEO Pharmaceuticals, Inc. Regulatory AVEO Oncology Announces U.S. FDA Approval of FOTIVDA® (tivozanib) for the Treatment of Adult Patients with Relapsed or Refractory Advanced Renal Cell Carcinoma aveooncology.com ↗
AVEO Oncology (Nasdaq: AVEO) today announced that the U.S. Food and Drug Administration (FDA) has approved FOTIVDA ® (tivozanib) for the treatment of adults with relapsed or refractory advanced renal cell carcinoma (RCC) who have received two or more prior systemic therapies.
2021-02-11 AVEO Pharmaceuticals, Inc. Results AVEO Oncology Announces Presentation of Key Subgroup and Quality of Life Analyses from the Phase 3 TIVO-3 Study of Tivozanib in Renal Cell Carcinoma aveooncology.com ↗
2021-01-15 AVEO Pharmaceuticals, Inc. Results AVEO Oncology Announces Results from Phase 1b Portion of DEDUCTIVE Study of Tivozanib (FOTIVDA®) in Combination with IMFINZI® (durvalumab) in Previously Untreated Metastatic Hepatocellular Carcinoma aveooncology.com ↗
The combination demonstrated a 29% partial response (PR) rate and 71% disease control rate (PR + stable disease).

All press releases naming this drug 146 releases

DateIssuerRelease
Show all 146 releases opens the full record — a long page

Evidence & citations 19 cited values

Every value below carries the sentence it was read from. 42 sources stand behind the page.

FieldValueCited text
Known as Tivozanib ClinicalTrials.gov intervention name — accepted as the source's own label NCT00502307 ↗
37

NCT00563147 ↗

NCT01030783 ↗

NCT01316848 ↗

NCT04645160 ↗

NCT01363804 ↗

NCT01297244 ↗

NCT01853644 ↗

NCT04987203 ↗

NCT01076010 ↗

NCT06661720 ↗

Show 27 more sources

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 ↗
1

NCT00970411 ↗

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 2014
2

“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 ↗