VOTRIENT (pazopanib hydrochloride)
VOTRIENT is indicated for the treatment of Advanced renal cell carcinoma; Advanced soft tissue sarcoma.
How VOTRIENT Works
Pazopanib is a multi-tyrosine kinase inhibitor that targets several receptors, including vascular endothelial growth factor receptors (VEGFR), platelet-derived growth factor receptors (PDGFR), and fibroblast growth factor receptors (FGFR). By blocking these receptors, the drug inhibits ligand-induced autophosphorylation and prevents signaling pathways that lead to angiogenesis. This mechanism interferes with the blood supply to tumors and suppresses tumor growth.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2009-10-19
- Routes
- ORAL
- Dosage Forms
- TABLET
VOTRIENT Approval History
What VOTRIENT Treats
2 indicationsVOTRIENT is approved for 2 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Advanced renal cell carcinoma
- Advanced soft tissue sarcoma
VOTRIENT Boxed Warning
HEPATOTOXICITY Severe and fatal hepatotoxicity has been observed in clinical trials. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended [see Warnings and Precautions (5.1)]. WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning. Severe and fatal hepatotoxicity has been observed in clinical trials. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended. ( 5.1 )...
WARNING: HEPATOTOXICITY Severe and fatal hepatotoxicity has been observed in clinical trials. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended [see Warnings and Precautions (5.1)]. WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning. Severe and fatal hepatotoxicity has been observed in clinical trials. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended. ( 5.1 )
VOTRIENT 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.
VOTRIENT 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 VOTRIENT's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications VOTRIENT treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to VOTRIENT
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
32 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02180867 results posted | NCI-2014-01340 NCI-2014-01340, ARST1321 | Ph 2, Ph 3 | active not recruiting | Radiation Therapy With or Without Combination Chemotherapy or Pazopanib Before Surgery in Treating Patients With Newly Diagnosed Non-rhabdomyosarcoma Soft Tissue Sarcomas That Can Be Removed by Surgery |
| NCT01841736 results posted | NCI-2013-00831 NCI-2013-00831, ALLIANCE A021202 | Ph 2 | active not recruiting | Pazopanib Hydrochloride in Treating Patients With Progressive Carcinoid Tumors |
| NCT01575548 results posted | NCI-2012-00723 NCI-2012-00723, CDR0000730383 | Ph 3 | active not recruiting | Pazopanib Hydrochloride in Treating Patients With Metastatic Kidney Cancer Who Have No Evidence of Disease After Surgery |
| NCT01552356 | NCI-2012-00690 NCI-2012-00690, MAYO-MC1112 | Ph 1 | active not recruiting | Pazopanib Hydrochloride in Treating Patients With Advanced or Refractory Solid Tumors |
| NCT01684397 | I 191711 NCI-2012-01247, 13-069 | Ph 1, Ph 2 | active not recruiting | Pazopanib Hydrochloride and Bevacizumab in Treating Patients With Previously Untreated Metastatic Kidney Cancer |
| NCT01436227 results posted | 2011-0465 NCI-2011-03285, 2011-0465 | Ph 2 | completed | Pazopanib Hydrochloride in Treating Patients With Von Hippel-Lindau Syndrome |
| NCT03660930 results posted | RG1718053 10015, NCI-2018-01624 | Ph 1, Ph 2 | terminated | Nab-Sirolimus and Pazopanib Hydrochloride in Treating Patients With Advanced Nonadipocytic Soft Tissue Sarcomas |
| NCT01767636 results posted | MC1152 NCI-2012-02027, MC1152 | Ph 2 | completed | Pazopanib Hydrochloride in Treating Patients With Metastatic Kidney Cancer |
| NCT01402271 | EORTC-55092 EU-21119, 2010-024077-39 | Ph 1, Ph 2 | completed | Pazopanib Hydrochloride, Paclitaxel, and Carboplatin in Treating Patients With Refractory or Resistant Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer |
| NCT02601209 results posted | NCI-2015-01929 NCI-2015-01929, A091304 | Ph 1, Ph 2 | terminated | Sapanisertib or Pazopanib Hydrochloride in Treating Patients With Locally Advanced or Metastatic Sarcoma |
| NCT01462630 results posted | SAR-043 NCI-2011-01314, 11-042 | Ph 2 | completed | Pazopanib Hydrochloride in Treating Patients With Advanced Angiosarcoma |
| NCT01236547 results posted | NCI-2011-02614 NCI-2011-02614, CDR0000688092 | Ph 2 | completed | Intensity-Modulated Radiation Therapy and Paclitaxel With or Without Pazopanib Hydrochloride in Treating Patients With Anaplastic Thyroid Cancer |
| NCT01157091 results posted | 10030 NCI-2010-01497 | Ph 2 | completed | Pazopanib Hydrochloride in Treating Patients With Stage IV Kidney Cancer |
| NCT02357810 results posted | NU 14S03 NCI-2014-02583, STU00200112 | Ph 2 | completed | Pazopanib Hydrochloride and Topotecan Hydrochloride in Treating Patients With Metastatic Soft Tissue and Bone Sarcomas |
| NCT01664182 results posted | NCI-2012-01289 NCI-2012-01289, PHII-122 | Ph 2 | completed | Trebananib With or Without Bevacizumab, Pazopanib Hydrochloride, Sorafenib Tosylate, or Sunitinib Malate in Treating Patients With Advanced Kidney Cancer |
| NCT03334409 results posted | ACCRU-GU-1703 NCI-2017-01998, ACCRU-GU-1703 | Ph 2 | terminated | Pazopanib Hydrochloride With or Without Ascorbic Acid in Treating Patients With Kidney Cancer That Is Metastatic or Cannot Be Removed by Surgery |
| NCT01532687 results posted | IRB00007943 NCI-2012-00052, IRB00007943 | Ph 2 | completed | Gemcitabine With or Without Pazopanib in Treating Patients With Refractory Soft Tissue Sarcoma |
| NCT01465659 results posted | NU 11I03 NCI-2011-02939, STU00053541 | Ph 1, Ph 2 | completed | Temozolomide and Pazopanib Hydrochloride in Treating Patients With Advanced Pancreatic Neuroendocrine Tumors That Cannot Be Removed By Surgery |
| NCT02979899 TAPPAS results posted | 105SAR301 | Ph 3 | completed | Trial of TRC105 and Pazopanib Versus Pazopanib Alone in Patients With Advanced Angiosarcoma |
| NCT00625846 results posted | NCI-2009-00198 NCI-2009-00198, MC057H | Ph 2 | completed | Pazopanib Hydrochloride in Treating Patients With Advanced Thyroid Cancer |
| NCT01247571 results posted | NCI-2011-02658 NCI-2011-02658, GOG-0230D | Ph 2 | completed | Pazopanib Hydrochloride in Treating Patients With Recurrent or Persistent Uterine Cancer |
| NCT01468909 results posted | NCI-2011-03635 NCI-2011-03635, CDR0000716028 | Ph 2 | completed | Paclitaxel With or Without Pazopanib Hydrochloride in Treating Patients With Persistent or Recurrent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cavity Cancer |
| NCT01713972 | OSU 12066 NCI-2012-01935, NCCNGSK20014 | Ph 1 | completed | Dabrafenib and Pazopanib Hydrochloride in Treating Patients With Advanced Malignant Tumors |
| NCT00861913 results posted | NCI-2009-01163 NCI-2009-01163, CDR0000637188 | Ph 2 | completed | Pazopanib Hydrochloride in Treating Patients With Metastatic Melanoma That Cannot be Removed by Surgery |
| NCT01158521 results posted | CASE4809 NCI-2010-01392 | Ph 2 | completed | Pazopanib Hydrochloride Before Surgery in Treating Patients With Kidney Cancer |
| NCT01394211 results posted | 11-0269-04 NCI-2011-01114, 3P30CA023074 | Ph 2 | terminated | Neo-adjuvant Therapy With Anastrozole Plus Pazopanib in Stage II and III ER+ Breast Cancer |
| NCT01208064 | EORTC-08092 2010-018566-23, EU-21072 | Ph 2, Ph 3 | terminated | Pazopanib Hydrochloride or a Placebo in Treating Patients With Non-Small Cell Lung Cancer Who Have Received First-Line Chemotherapy |
| NCT01340794 results posted | NCI-2011-02588 NCI-2011-02588, CDR0000699430 | Ph 2 | terminated | Pazopanib Hydrochloride in Treating Patients With Advanced or Progressive Malignant Pheochromocytoma or Paraganglioma |
| NCT01413113 | 7529 NCI-2011-01139, 7529 | Ph 1 | completed | Iodine I 131 and Pazopanib Hydrochloride in Treating Patients With Recurrent and/or Metastatic Thyroid Cancer Previously Treated With Iodine I 131 That Cannot Be Removed By Surgery |
| NCT00471536 results posted | NCI-2009-00203 NCI-2009-00203, CDR0000543460 | Ph 2 | completed | Pazopanib in Treating Patients With Metastatic Urothelial Cancer |
| NCT00929903 | NCI-2011-01929 NCI-2011-01929, COG-ADVL0815 | Ph 1 | completed | Pazopanib Hydrochloride in Treating Young Patients With Solid Tumors That Have Relapsed or Not Responded to Treatment |
| NCT01031875 | ITA-MIL-IRCCS-INT-70/09 CDR0000661071, EUDRACT-2009-017093-20 | Ph 2 | completed | Pazopanib Hydrochloride in Treating Patients With Metastatic Urethral Cancer or Bladder Cancer That Has Relapsed or Not Responded to Treatment |
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.
VOTRIENT FDA Label Details
Indications & Usage
FDA Label (PDF)VOTRIENT is indicated for the treatment of Advanced renal cell carcinoma; Advanced soft tissue sarcoma.
WARNING: HEPATOTOXICITY Severe and fatal hepatotoxicity has been observed in clinical trials. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended [see Warnings and Precautions (5.1)]. WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning...
Track VOTRIENT with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
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