Fotivda

(Tivozanib)

ApprovedSmall molecule

Tivozanib is used to treat advanced kidney cancer. It works by slowing or stopping the growth of cancer cells by blocking proteins that help tumors develop new blood vessels.[2] Fotivda is currently approved and in use across 12 indications[4].[1]

Fotivda is one of 321 small molecule programs targeting Renal Cell Adenocarcinoma. It is currently in Approved.

Indications

Total Trials

Active Trials

320

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Renal Cell AdenocarcinomaApproved

Colorectal CancerApproved

Glioblastoma MultiformeApproved

Breast CancerApproved

Ovarian CancerApproved

Fallopian Tube CancerApproved

CholangiocarcinomaRecruiting

Clear Cell Renal Cell CarcinomaRecruiting

Bile Duct CancerRecruiting

Metastatic Renal Cell CancerNot yet recruiting

Renal Cell AdenocarcinomaApproved

Approved

Colorectal CancerApproved

Approved

Glioblastoma MultiformeApproved

Approved

Breast CancerApproved

Approved

Ovarian CancerApproved

Approved

Fallopian Tube CancerApproved

Approved

CholangiocarcinomaPreclinical

Recruiting

Clear Cell Renal Cell CarcinomaPhase 3

Recruiting

Bile Duct CancerPreclinical

Recruiting

Metastatic Renal Cell CancerPhase 2

Not yet recruiting

Showing 10 of 12 indications

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Fotivda

AAVEO Pharmaceuticals, Inc.

Approved

31 2

Lexiscan

Astellas

Preclinical

1 3

Voltaren

Novartis

Preclinical

1 4

Zolymbus

AbbVie

Preclinical

1 5

Blenoxane

Bristol-Myers Squibb

Preclinical

1 6

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 7

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 8

Duragesic-100

CCephalon

Preclinical

2 9

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

2 10

Spravato

WWim Janssens

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

PreclinicalRecruiting

Bile Duct Cancer

NCT05000294

Q3 2027

Phase 2Not yet recruiting

Metastatic Renal Cell Cancer

NCT07218692

Q4 2028

Phase 2Recruiting

Renal Cell Carcinoma

NCT06053658

Q4 2029

PreclinicalRecruiting

Cholangiocarcinoma

NCT04645160

Clinical

Trials by Indication[1]

Renal Cell Carcinoma5 trials

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

Active, not recruiting·AAVEO Pharmaceuticals, Inc.·Phase 3·NCT04987203·343 enrolled

A Study to Compare Tivozanib (AV-951) to Sorafenib in Subjects With Advanced Renal Cell Carcinoma

Completed·AAVEO Pharmaceuticals, Inc.·Phase 3·NCT01030783·517 enrolled

A Study of Tivozanib (AV-951), an Oral VEGF Receptor Tyrosine Kinase Inhibitor, in the Treatment of Renal Cell Carcinoma

Completed·AAVEO Pharmaceuticals, Inc.·Phase 2·NCT00502307·272 enrolled

Show 2 more trials

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

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT06053658·48 enrolled

A Biomarker Study of Tivozanib in Subjects With Advanced Renal Cell Carcinoma

Completed·AAVEO Pharmaceuticals, Inc.·Phase 2·NCT01297244·105 enrolled

Metastatic Colorectal Cancer2 trials

RAD001 and AV-951 in Patients With Refractory, Metastatic Colorectal Cancer

Completed·—·Phase 1/2·NCT01058655·56 enrolled

A Study Combining mFOLFOX6 With Tivozanib or Bevacizumab in Patients With Metastatic Colorectal Cancer as First Line Therapy

Completed·AAVEO Pharmaceuticals, Inc.·Phase 2·NCT01478594·265 enrolled

Phase 12 trials

A Phase 1 Study to Evaluate the Effect of Rifampin on the Pharmacokinetics of Tivozanib in Healthy Subjects

Completed·AAVEO Pharmaceuticals, Inc.·Phase 1·NCT01363804·30 enrolled

A Phase 1 Study to Evaluate The Effect of Ketoconazole on the Pharmacokinetics of Tivozanib in Healthy Subjects

Completed·AAVEO Pharmaceuticals, Inc.·Phase 1·NCT01363778·30 enrolled

Non-Small Cell Lung Cancer2 trials

An Open-Label Study of QD Oral Administration of Tivozanib (AV-951) in Subjects With Non-Small Cell Lung Cancer (NSCLC)

Completed·AAVEO Pharmaceuticals, Inc.·Phase 1·NCT00826878·17 enrolled

A Phase I/II Study of Tivozanib and Erlotinib as Initial Treatment for Metastatic Non-small Cell Lung Cancer Assigned by VeriStrat® Serum Proteomic Evaluation

Withdrawn·UUniversity of Utah·Phase 1/2·NCT01728181

Maintenance Therapy1 trial

Tivozanib As Maintenance Therapy In GYN

Terminated·—·Phase 2·NCT01972516·4 enrolled

19 more indications

Gemcitabine1 trial

Tivozanib + Gemcitabine in Metastatic RCC

Withdrawn·—·Phase 2·NCT01834183

Liver Cancer1 trial

Tivozanib in Treating Patients With Liver Cancer That Is Metastatic or Cannot Be Removed by Surgery

Completed·RRoswell Park Cancer Institute·Phase 1/2·NCT01835223·33 enrolled

Single Dose1 trial

A Single Center, Open-label, Randomized, Two-period Crossover Food Effect Study of Single Doses of Tivozanib (AV-951) in Healthy Subjects

Completed·AAVEO Pharmaceuticals, Inc.·Phase 1·NCT01316848·30 enrolled

ESS1 trial

A Rollover Protocol to Allow Continued Access to Tivozanib (AV 951) for Subjects Enrolled in Other Tivozanib Protocols

Terminated·AAVEO Pharmaceuticals, Inc.·N/A·NCT01369433·225 enrolled

Hepatocellular Cancer1 trial

Phase II Trial of Tivozanib in Advanced Hepatocellular Cancer

Terminated·EEmory University·Phase 2·NCT01807156·7 enrolled

Metastatic1 trial

A Subject Treatment Preference Study of Tivozanib Versus Sunitinib in Subjects With Metastatic RCC

Terminated·AAVEO Pharmaceuticals, Inc.·Phase 2·NCT01673386·58 enrolled

Soft Tissue Sarcoma1 trial

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

Completed·NNorthwestern University·Phase 2·NCT01782313·58 enrolled

Kidney Cancer1 trial

Tivozanib Before Surgery in Treating Patients With Localized Kidney Cancer

Withdrawn·RRoswell Park Cancer Institute·N/A·NCT01769885

Primary Peritoneal Cancer1 trial

Tivozanib in Recurrent, Platinum-Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Completed·NNorthwestern University·Phase 2·NCT01853644·31 enrolled

Metastatic Renal Cell Cancer1 trial

RP2 and Tivozanib for the Treatment of Metastatic Renal Cell Cancer After Progression on Immunotherapy

Not yet recruiting·—·Phase 2·NCT07218692·35 enrolled

Nivolumab1 trial

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

Completed·AAVEO Pharmaceuticals, Inc.·Phase 1/2·NCT03136627·28 enrolled

Kidney Carcinoma1 trial

An Extension Treatment Protocol for Subjects Who Have Participated in a Study of Tivozanib Versus Sorafenib in Kidney Carcinoma (Protocol AV-951-09-301).

Completed·AAVEO Pharmaceuticals, Inc.·Phase 3·NCT01076010·277 enrolled

Advanced Solid Tumors1 trial

A Cardiac Safety Study of Tivozanib to Evaluate the Electrocardiogram and Pharmacokinetic-Electrocardiogram Dynamics in Subjects With Advanced Solid Tumors

Completed·AAVEO Pharmaceuticals, Inc.·Phase 1·NCT01210846·50 enrolled

Hepatocellular Carcinoma1 trial

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

Terminated·AAVEO Pharmaceuticals, Inc.·Phase 1/2·NCT03970616·27 enrolled

Glioblastoma1 trial

Tivozanib for Recurrent Glioblastoma

Completed·MMassachusetts General Hospital·Phase 2·NCT01846871·10 enrolled

Prostate Cancer1 trial

Tivozanib + Enzalutamide in Adv Prostate Cancer

Terminated·MMassachusetts General Hospital·Phase 2·NCT01885949·5 enrolled

Clear Cell Renal Cell Carcinoma1 trial

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

Recruiting·AAlliance for Clinical Trials in Oncology·Phase 3·NCT06661720·1,040 enrolled

Cholangiocarcinoma1 trial

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

Recruiting·NNational Cancer Institute (NCI)·Preclinical·NCT04645160·31 enrolled

Bile Duct Cancer1 trial

Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types

Recruiting·UUniversity of Florida·Preclinical·NCT05000294·29 enrolled

Regulatory

FDA Approval Timeline[5]

Mar 10, 2021

FOTIVDA

NDA NDA212904

Sources

References

[1]
ClinicalTrials.gov — 31 trial records for Tivozanib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Fotivda drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Tivozanib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Tivozanib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA212904). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Fotivda. U.S. Food & Drug Administration.
[7]
SEC EDGAR — AVEO Pharmaceuticals, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Platelet-Derived Growth Factor Receptor Beta Inhibitor; Vascular Endothelial Growth Factor Receptor Inhibitor; Stem Cell Growth Factor Receptor Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: AAVEO Pharmaceuticals, Inc.

Patent Landscape[6]

Patent Cliff

Nov 16, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7166722Nov 16, 2028

11504365Nov 5, 2039

Fotivda

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q3 2027

Q4 2028

Q4 2029

Trials by Indication[1]

Renal Cell Carcinoma5 trials

Metastatic Colorectal Cancer2 trials

Phase 12 trials

Non-Small Cell Lung Cancer2 trials

Maintenance Therapy1 trial

Gemcitabine1 trial

Liver Cancer1 trial

Single Dose1 trial

ESS1 trial

Hepatocellular Cancer1 trial

Metastatic1 trial

Soft Tissue Sarcoma1 trial

Kidney Cancer1 trial

Primary Peritoneal Cancer1 trial

Metastatic Renal Cell Cancer1 trial

Nivolumab1 trial

Kidney Carcinoma1 trial

Advanced Solid Tumors1 trial

Hepatocellular Carcinoma1 trial

Glioblastoma1 trial

Prostate Cancer1 trial

Clear Cell Renal Cell Carcinoma1 trial

Cholangiocarcinoma1 trial

Bile Duct Cancer1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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