FOTIVDA
PeakSMtivozanib
NDAORALCAPSULE
Approved
Mar 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
7
Data completeness
6/8 — Strong
FOTIVDA (tivozanib) is inhibitor. First approved in 2021.
Drug data last refreshed 9h ago · AI intelligence enriched 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FOTIVDA (tivozanib) is an oral small-molecule VEGF receptor inhibitor approved in 2021 for renal cell carcinoma. It works by inhibiting phosphorylation of VEGFR-1, VEGFR-2, and VEGFR-3, along with c-kit and PDGFRβ, to block angiogenesis and tumor growth. The drug represents a targeted oncology approach for patients with advanced kidney cancer.
$0.102BPart D
Peak13.1 years to LOEProduct is in peak commercial phase with ~$102M in Medicare spending (2023) and modest claim volume, suggesting stable mid-tier oncology positioning with established but not dominant market presence.
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
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (7)
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
Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types
Started Dec 2021
29 enrolled
Bile Duct CancerGall Bladder CancerBreast Cancer+6 more
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
A Study of Tivozanib in Combination With Durvalumab in Subjects With Advanced Hepatocellular Carcinoma
Started Sep 2019
27 enrolled
Hepatocellular Carcinoma
Phase 1/2 Study of Tivozanib in Combination With Nivolumab in Subjects With RCC
Started Mar 2017
28 enrolled
Carcinoma, Renal Cell
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.