FOTIVDA (tivozanib hydrochloride)
Fotivda treats adults with advanced renal cell carcinoma that has returned or failed to respond to previous interventions. It is used for patients who have already undergone at least two prior systemic therapies for their kidney cancer. This medication helps manage advanced disease in cases where earlier treatment lines were not successful.
How FOTIVDA Works
This drug works by blocking tyrosine kinases, specifically targeting vascular endothelial growth factor receptors 1, 2, and 3. By inhibiting these receptors and others like c-kit and PDGFR β, the medication helps prevent the growth of new blood vessels and slows the progression of tumor cells.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2021-03-10
- Patent Cliff
- 2039
- Routes
- ORAL
- Dosage Forms
- CAPSULE
FOTIVDA Approval History
What FOTIVDA Treats
1 indicationsFOTIVDA is approved for 1 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Renal Cell Carcinoma
FOTIVDA Target & Pathway
ProTarget
Receptors on blood vessel cells that respond to VEGF signals to form new blood vessels. Cancer cells exploit this pathway to ensure blood supply for tumor growth. Blocking VEGFRs prevents tumor angiogenesis and limits cancer progression.
Pathway Context
VEGFR on blood vessels is activated by VEGF to promote angiogenesis
A signaling protein that stimulates the formation of new blood vessels (angiogenesis). Tumors need blood supply to grow, so they secrete VEGF to create new vessels. Blocking VEGF starves tumors of oxygen and nutrients, inhibiting their growth.
FOTIVDA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in FOTIVDA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications FOTIVDA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to FOTIVDA
3 of 15FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02627963 results posted | AV-951-15-303 | Ph 3 | completed | A Study to Compare Tivozanib Hydrochloride to Sorafenib in Participants With Refractory Advanced Renal Cell Carcinoma (RCC) |
| NCT01745367 BATON-BC results posted | AV-951-12-204 2012-003507-35 | Ph 2 | terminated | Tivozanib in Combination With Paclitaxel in Patients With Locally Recurrent or Metastatic Triple Negative Breast Cancer |
| NCT01631097 | AV-951-12-118 | Ph 1 | completed | A Single-Dose Study of Tivozanib in Subjects With Hepatic Impairment and Normal Hepatic Function |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
FOTIVDA FDA Label Details
Indications & Usage
FDA Label (PDF)FOTIVDA is indicated for the treatment of Renal Cell Carcinoma.
FOTIVDA Patents & Exclusivity
Patents (2 active)
Exclusivity
Pro Intelligence Preview
Deep insights for FOTIVDA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2039
- • 8 active patents
Trial Analysis
- • 3 total trials
- • Stage: Declining
Competitive Landscape
- • 15 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment