PAZOPANIB HYDROCHLORIDE
PAZOPANIB HYDROCHLORIDE is indicated for the treatment of Renal Cell Carcinoma; Soft Tissue Sarcoma.
How PAZOPANIB HYDROCHLORIDE Works
Pazopanib is a multi-tyrosine kinase inhibitor that targets vascular endothelial growth factor receptors (VEGFR-1, -2, and -3), platelet-derived growth factor receptors (PDGFR-α and -β), fibroblast growth factor receptors (FGFR-1 and -3), cytokine receptor (Kit), and other kinases including Itk, Lck, and c-Fms. By inhibiting these targets, it prevents ligand-induced autophosphorylation and subsequent signaling pathways, leading to the inhibition of angiogenesis and tumor growth.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2023-10-19
- Routes
- ORAL
- Dosage Forms
- TABLET
PAZOPANIB HYDROCHLORIDE Approval History
What PAZOPANIB HYDROCHLORIDE Treats
2 indicationsPAZOPANIB HYDROCHLORIDE is approved for 2 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Renal Cell Carcinoma
- Soft Tissue Sarcoma
PAZOPANIB HYDROCHLORIDE 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 )
PAZOPANIB HYDROCHLORIDE 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.
PAZOPANIB HYDROCHLORIDE 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 PAZOPANIB HYDROCHLORIDE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications PAZOPANIB HYDROCHLORIDE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to PAZOPANIB HYDROCHLORIDE
3 of 17FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
151 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05432791 results posted | NCI-2022-05065 NCI-2022-05065, A092104 | Ph 2, Ph 3 | active not recruiting | Testing Olaparib and Temozolomide Versus the Usual Treatment for Uterine Leiomyosarcoma After Chemotherapy Has Stopped Working |
| NCT02331498 PAZOGLIO | 2012/49 | Ph 1, Ph 2 | active not recruiting | Phase I/II Study of Pazopanib+ Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme |
| 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 |
| NCT06239272 | NRSTS2021 NCI-2024-02554 | Ph 1, Ph 2 | recruiting | NRSTS2021, A Risk Adapted Study Evaluating Maintenance Pazopanib, Limited Margin, Dose-Escalated Radiation Therapy and Selinexor in Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS) |
| NCT01642017 VOTRAGE | 11GENE06 | Ph 1 | terminated | Phase I Clinical and Pharmacokinetic Study of Pazopanib in a Population of Frail Elderly Patients According SIOG Criteria |
| 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 |
| NCT02555748 SUP-R | 14 URO 06 | Ph 4 | completed | Therapeutic Drug Monitoring of Sunitinib and Pazopanib in Advanced or Metastatic Renal Cell Carcinoma |
| NCT03850964 Paz | HT2 CDMRP-PR203473, 1R01FD006840-01A1 | Ph 2, Ph 3 | active not recruiting | Effects of Pazopanib on Hereditary Hemorrhagic Telangiectasia Related Epistaxis and Anemia (Paz) |
| NCT07444619 | 2025-1035 NCI-2026-01398 | Ph 1 | not yet recruiting | A Phase I Study of Pazopanib in Combination With Trabectedin, Ipilimumab and Nivolumab (TraPIN) in Pediatric and Young Adult Patients With Recurrent Soft Tissue Sarcomas |
| 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 |
| NCT05180695 AMPHISARC | ET20-297 | Ph 1, Ph 2 | active not recruiting | HDM201 and Pazopanib in Patients With P53 Wild-type Advanced/Metastatic Soft Tissue Sarcomas |
| NCT01217931 | 2010-0085 NCI-2011-00256 | Ph 2 | active not recruiting | Sequential Two-agent Assessment in Renal Cell Carcinoma Therapy: The START Trial |
| NCT01931098 results posted | 160034 16-C-0034 | Ph 2 | completed | Oral Pazopanib Plus Oral Topotecan Metronomic Antiangiogenic Therapy for Recurrent Glioblastoma Multiforme (A) Without Prior Bevacizumab Exposure and (B) After Failing Prior Bevacizumab |
| NCT06263231 INVINCIBLE-3 | IT-03 | Ph 3 | active not recruiting | A Study to Investigate Efficacy & Safety of Intratumoral INT230-6 Compared to US Standard of Care in Adults With Soft Tissue Sarcomas (INVINCIBLE-3) |
| NCT03260894 results posted | KEYNOTE-679/ECHO-302 2024-512016-22-00, 2017-002259-26 | Ph 3 | completed | Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care in mRCC (KEYNOTE-679/ECHO-302) |
| NCT07087158 | IBR854-203 | Ph 2 | not yet recruiting | A Study of IBR854 Combined With Pazopanib Versus Pazopanib in Advanced Renal Cell Carcinoma |
| 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 |
| NCT03592472 | XYN-602 | Ph 3 | recruiting | A Study of Pazopanib With or Without Abexinostat in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma (RENAVIV) |
| NCT00720941 COMPARZ results posted | 108844 2008-002102-19, CPZP034A2301 | Ph 3 | completed | Pazopanib Versus Sunitinib in the Treatment of Locally Advanced and/or Metastatic Renal Cell Carcinoma |
| NCT01147822 results posted | 113078 CPZP034A2201, VEG113078 | Ph 2 | completed | Pazopanib Versus Sunitinib in the Treatment of Asian Subjects With Locally Advanced and/or Metastatic Renal Cell Carcinoma |
| NCT01767636 results posted | MC1152 NCI-2012-02027, MC1152 | Ph 2 | completed | Pazopanib Hydrochloride in Treating Patients With Metastatic Kidney Cancer |
| NCT06816771 | SDZLEC2024-413-02 | Ph 2 | recruiting | Evaluation of the Efficacy and Safety of Pazopanib in Combination with TGI/CIV for Recurrent or Refractory Rhabdomyosarcoma in Children or Adolescents |
| NCT02203760 PazoDoble | NOGGO U1 2012-003810-15 | Ph 2 | active not recruiting | Pazopanib Vs. Pazopanib Plus Gemcitabine |
| NCT02009449 IVY | 17159 J1L-AM-JZGA, AM0010-001 | Ph 1 | completed | A Phase 1 Study of Pegilodecakin (LY3500518) in Participants With Advanced Solid Tumors |
| NCT02207309 results posted | NPM001 2013-000522-58 | Ph 2 | terminated | Pazopanib Maintenance Phase II |
| 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 |
| NCT00827372 results posted | 0811-15 /IUCRO-0248 | Ph 2 | completed | A Study of Vascular Endothelial Growth Factor (VEGF) Inhibition in Patients With Unilateral Upper Extremity Lymphedema Following Treatment for Cancer |
| NCT02383251 TAPAZ | GINECO-OV231 | Ph 2 | completed | Paclitaxel/Pazopanib for Platinum Resistant/Refractory Ovarian Cancer |
| NCT03200717 IO-PAZ results posted | CPZP034A2410 2017-000708-10 | Ph 2 | completed | Study of Efficacy, Safety, and Quality of Life of Pazopanib in Patients With Advanced and/or Metastatic Renal Cell Carcinoma After Prior Checkpoint Inhibitor Treatment |
| NCT01430572 | 2011-0322 NCCN-GSKP05, NCI-2011-03040 | Ph 1 | completed | Pazopanib and Everolimus in PI3KCA Mutation Positive/PTEN Loss Patients |
| NCT02066285 | GEIS-32 2013-005456-15 | Ph 2 | completed | Trial of Pazopanib in Patients With Solitary Fibrous Tumor and Extraskeletal Myxoid Chondrosarcoma |
| NCT01330966 results posted | AAPSMCS1002 | Ph 2 | completed | Study of Pazopanib in the Treatment of Surgically Unresectable or Metastatic Chondrosarcoma |
| NCT01407562 | Pro0220110062 P30CA072720, NCI-2011-02448 | Ph 1 | terminated | Study of Pazopanib, Paclitaxel, and Carboplatin in Patients With Advanced Solid Tumors |
| 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 |
| NCT01468922 results posted | 120009 12-C-0009 | Ph 1 | completed | Pazopanib and ARQ 197 for Advanced Solid Tumors |
| 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 |
| NCT01566747 | CTRIAL-IE (ICORG) 10-01 | Ph 2 | completed | Second-line Pazopanib Renal Cell Carcinoma (RCC) Study. CTRIAL-IE (ICORG) 10-01, V5 |
| NCT01472081 results posted | CA209-016 | Ph 1 | completed | Nivolumab (BMS-936558; MDX-1106) in Combination With Sunitinib, Pazopanib, or Ipilimumab in Subjects With Metastatic Renal Cell Carcinoma (RCC) (CheckMate 016) |
| NCT01035658 results posted | SCRI GYN 26 | Ph 1, Ph 2 | terminated | Pazopanib/Doxil in Adv Relapsed Plat Sensitive or Resistant Ovarian, Fallopian or Primary Peritoneal Adenocarcinoma |
| NCT01532687 results posted | IRB00007943 NCI-2012-00052, IRB00007943 | Ph 2 | completed | Gemcitabine With or Without Pazopanib in Treating Patients With Refractory Soft Tissue Sarcoma |
| NCT01392183 results posted | 2011-0358 NCI-2011-01277 | Ph 2 | completed | Pazopanib Versus Temsirolimus in Poor-Risk Clear-Cell Renal Cell Carcinoma (RCC) |
| NCT01548144 | 2011-1142 NCI-2012-00324 | Ph 1 | terminated | Pazopanib or Pemetrexed and Crizotinib in Advanced Cancer |
Showing 50 of 151 trials
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.
PAZOPANIB HYDROCHLORIDE FDA Label Details
Indications & Usage
PAZOPANIB HYDROCHLORIDE is indicated for the treatment of Renal Cell Carcinoma; 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 warnin...
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VOTRIENT
Full clinical data, patents, trials, and competitive landscape for pazopanib hydrochloride.
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