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 19 indications[4].[1]

Fotivda is one of 484 small molecule programs targeting Kidney Cancer. It is currently in Approved.

Indications

Total Trials

Active Trials

483

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Kidney CancerActive, not recruiting

Liver CancerActive, not recruiting

Metastatic Colorectal CancerActive, not recruiting

Biliary Tract CancerActive, not recruiting

Fallopian Tube CancerApproved

Non-Small Cell Lung CancerActive, not recruiting

Breast CancerApproved

Colorectal CancerApproved

Prostate CancerActive, not recruiting

Ovarian CancerApproved

Kidney CancerPhase 3

Active, not recruiting

Liver CancerPhase 1/Phase 2

Active, not recruiting

Metastatic Colorectal CancerPhase 2

Active, not recruiting

Biliary Tract CancerPhase 1/Phase 2

Active, not recruiting

Fallopian Tube CancerApproved

Approved

Non-Small Cell Lung CancerPhase 1

Active, not recruiting

Breast CancerApproved

Approved

Colorectal CancerApproved

Approved

Prostate CancerPhase 2

Active, not recruiting

Ovarian CancerApproved

Approved

Showing 10 of 19 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Fotivda

AAVEO Pharmaceuticals, Inc.

Approved

31 2

Trodelvy

Gilead

Preclinical

37 3

Prolia

Amgen

Preclinical

14 4

Megace

Bristol-Myers Squibb

Preclinical

4 5

Cymbalta

Alnylam Pharmaceuticals

Preclinical

3 6

MS Contin

Merck & Co.

Preclinical

2 7

Zinecard

CChildren's Oncology Group

Preclinical

2 8

Chirocaine

PPurdue Pharma LP

Preclinical

1 9

Acupan

YYonsei University

Preclinical

1 10

Feraheme

AAzurity Pharmaceuticals

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

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

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 Biomarker Study of Tivozanib in Subjects With Advanced Renal Cell Carcinoma

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

Show 2 more trials

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

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

Non-Small Cell Lung Cancer2 trials

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

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

Metastatic Colorectal Cancer2 trials

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

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

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

Phase 12 trials

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

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

Primary Peritoneal Cancer1 trial

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

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

19 more indications

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

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

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

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

Gemcitabine1 trial

Tivozanib + Gemcitabine in Metastatic RCC

Withdrawn·—·Phase 2·NCT01834183

Kidney Cancer1 trial

Tivozanib Before Surgery in Treating Patients With Localized Kidney Cancer

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

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

Prostate Cancer1 trial

Tivozanib + Enzalutamide in Adv Prostate Cancer

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

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

Glioblastoma1 trial

Tivozanib for Recurrent Glioblastoma

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

Maintenance Therapy1 trial

Tivozanib As Maintenance Therapy In GYN

Terminated·—·Phase 2·NCT01972516·4 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

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

Bile Duct Cancer1 trial

Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types

Recruiting·UUniversity of Florida·Preclinical·NCT05000294·29 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

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

Non-Small Cell Lung Cancer2 trials

Metastatic Colorectal Cancer2 trials

Phase 12 trials

Primary Peritoneal Cancer1 trial

Advanced Solid Tumors1 trial

Hepatocellular Carcinoma1 trial

Nivolumab1 trial

Soft Tissue Sarcoma1 trial

Metastatic1 trial

Gemcitabine1 trial

Kidney Cancer1 trial

Metastatic Renal Cell Cancer1 trial

Prostate Cancer1 trial

ESS1 trial

Hepatocellular Cancer1 trial

Kidney Carcinoma1 trial

Glioblastoma1 trial

Maintenance Therapy1 trial

Single Dose1 trial

Liver Cancer1 trial

Bile Duct Cancer1 trial

Clear Cell Renal Cell Carcinoma1 trial

Cholangiocarcinoma1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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