FOTIVDA

PeakSM

tivozanib

NDAORALCAPSULE
Approved
Mar 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
7

Mechanism of Action

inhibitor. In vitro cellular kinase assays demonstrated that tivozanib inhibits phosphorylation of vascular endothelial growth factor receptor (VEGFR)-1, VEGFR-2 and VEGFR-3 and inhibits other kinases including c-kit and PDGFR β at clinically relevant concentrations. In tumor xenograft models in…

Indications (2)

refractory advanced renal cell carcinoma (RCC) following twomore prior systemic therapies

Clinical Trials (5)

NCT06661720Phase 3Recruiting

Testing the Addition of the Anti-Cancer Drug Tivozanib to Immunotherapy (Pembrolizumab) After Surgery to Remove All Known Sites of Kidney Cancer

Started Mar 2025
1,040 enrolled
Clear Cell Renal Cell CarcinomaRenal Cell Carcinoma (RCC)Stage II Renal Pelvis Cancer AJCC v8+1 more
NCT05000294Phase 1/2Suspended

Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types

Started Dec 2021
29 enrolled
Bile Duct CancerGall Bladder CancerBreast Cancer+6 more
NCT04987203Phase 3Active Not Recruiting

Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma

Started Sep 2021
343 enrolled
Renal Cell Carcinoma
NCT03970616Phase 1/2Terminated

A Study of Tivozanib in Combination With Durvalumab in Subjects With Advanced Hepatocellular Carcinoma

Started Sep 2019
27 enrolled
Hepatocellular Carcinoma
NCT03136627Phase 1/2Completed

Phase 1/2 Study of Tivozanib in Combination With Nivolumab in Subjects With RCC

Started Mar 2017
28 enrolled
Carcinoma, Renal Cell

Loss of Exclusivity

LOE Date
Nov 5, 2039
166 months away
Patent Expiry
Nov 5, 2039
Exclusivity Expiry
Mar 10, 2026

Patent Records (2)

Patent #ExpiryTypeUse Code
7166722
Nov 16, 2028
SubstanceProduct
—
11504365
Nov 5, 2039
U-3476
External Resources
DailyMed
Full prescribing information
FDA Drugs@FDA
FDA approval history
RxNorm
Drug nomenclature & identifiers