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Drug

Tivozanib

Approved · EMA
Late-stage development

Also known as Fotivda.

RxNorm2534233ChEMBLCHEMBL1289494UNII172030934T
5
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types

Clinical trial2026-07-13Results expected Q4 2026 · ClinicalTrials.gov

Short TeRm Intensified Pembrolizumab (KEytruda) and Tivozanib for High-Risk Renal Cell Carcinoma - STRIKE

Clinical trial2026-07-02Results expected Q4 2037 · ClinicalTrials.gov

Phase II Study Evaluating Efficacy of Tivozanib (AV-951) in Biliary Tract Cancers

Clinical trial2026-06-30Results expected Q4 2028 · ClinicalTrials.gov

Phase 2 Study of Combination Tivozanib and Nivolumab in Advanced Non-Clear Cell Renal Cell Carcinoma

Clinical trial2026-05-20Results expected Q4 2026 · ClinicalTrials.gov

TiNivo-2: A Phase 3, Randomized, Controlled, Multicenter, Open-label Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma Who Have Progressed Following One or Two Lines of Therapy Where One Line Has an Immune Checkpoint Inhibitor

Clinical trial2026-01-20Completed · ClinicalTrials.gov

A Phase 2 Study of RP2 With Tivozanib in Patients With Metastatic Renal Carcinoma After Progression to Immunotherapy

Clinical trial2025-10-20Results expected Q3 2027 · ClinicalTrials.gov

Phase 2 Combination Trial of Tivozanib and Enzalutamide in Men With Advanced Prostate Cancer

Clinical trial2024-05-23Terminated · ClinicalTrials.gov

A Phase 1b/2, Open-Label, Study of Tivozanib in Combination With Durvalumab in Subjects With Advanced Hepatocellular Carcinoma

Clinical trial2023-04-04Terminated · ClinicalTrials.gov

The Efficacy and Safety of Tivozanib in Recurrent, Platinum-Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Clinical trial2021-10-12Results posted · ClinicalTrials.gov

A Phase 1b/2, Open-Label, Multi-Center Study of Tivozanib in Combination With Nivolumab in Subjects With Metastatic Renal Cell Carcinoma

Clinical trial2021-06-18Completed · ClinicalTrials.gov

Multicenter Phase 1b/2 Study of Tivozanib in Patients With Advanced Inoperable Hepatocellular Carcinoma

Clinical trial2020-10-28Results posted · ClinicalTrials.gov

Approval: Fotivda (EMA)

Regulatory2017-08-24EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Tivozanib
Aliases & brands
Fotivda
RxNorm CUI
2534233
ChEMBL ID
CHEMBL1289494
UNII
172030934T
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2017-08-24
Latest approval
2017-08-24
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2017-08-24Approval
Approval: Fotivda (EMA)
Indication: Fotivda is indicated for the first line treatment of adult patients with advanced renal cell carcinoma (RCC) and for adult patients who are VEGFR and mTOR pathway inhibitor-naïve… Show full indication

Fotivda is indicated for the first line treatment of adult patients with advanced renal cell carcinoma (RCC) and for adult patients who are VEGFR and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for advanced RCC. Treatment of advanced renal cell carcinoma.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

31 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
31
registered trials across all phases
LATEST COMPLETION 2026
5
Active studies
5
Recruiting
6
Late-stage (III+)
17
Completed
9
Discontinued
PHASE DISTRIBUTIONn = 31
Phase 15Phase 1 / 27Phase 213Phase 34Phase N / A2

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Short TeRm Intensified Pembrolizumab (KEytruda) and Tivozanib for High-Risk Renal Cell Carcinoma - STRIKE

RecruitingPH IIIKey trialAlliance for Clinical Trials in Oncologyn=1,0402037

TiNivo-2: A Phase 3, Randomized, Controlled, Multicenter, Open-label Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma Who Have Progressed Following One or Two Lines of Therapy Where One Line Has an Immune Checkpoint Inhibitor

CompletedPH IIIAVEO Pharmaceuticals, Inc.n=3432026

An Extension Treatment Protocol for Subjects Who Have Participated in a Phase 3 Study of Tivozanib vs. Sorafenib in Renal Cell Carcinoma (Protocol AV-951-09-301).

CompletedPH IIIAVEO Pharmaceuticals, Inc.n=2772014

A Phase 3, Randomized, Controlled, Multi-Center, Open-Label Study to Compare Tivozanib (AV-951) to Sorafenib in Subjects With Advanced Renal Cell Carcinoma (TIVO-1)

CompletedPH IIIAVEO Pharmaceuticals, Inc.n=5172013

Recent completions

Trials that read out recently, adding to the completed evidence base.

TiNivo-2: A Phase 3, Randomized, Controlled, Multicenter, Open-label Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma Who Have Progressed Following One or Two Lines of Therapy Where One Line Has an Immune Checkpoint Inhibitor

CompletedPH IIIAVEO Pharmaceuticals, Inc.n=3432026

A Phase 1b/2, Open-Label, Multi-Center Study of Tivozanib in Combination With Nivolumab in Subjects With Metastatic Renal Cell Carcinoma

CompletedPH I/IIAVEO Pharmaceuticals, Inc.n=282021

The Efficacy and Safety of Tivozanib in Recurrent, Platinum-Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer

CompletedPH IINorthwestern Universityn=312021

Multicenter Phase 1b/2 Study of Tivozanib in Patients With Advanced Inoperable Hepatocellular Carcinoma

CompletedPH I/IIRoswell Park Cancer Instituten=332019

A Phase II Study of Tivozanib in Patients With Metastatic and Non-resectable Soft Tissue Sarcomas

CompletedPH IINorthwestern Universityn=582016

A Phase II Study of Tivozanib in Recurrent Glioblastoma

CompletedPH IIMassachusetts General Hospitaln=102016
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.