CLINICAL TRIALS PROFILE FOR PAZOPANIB HYDROCHLORIDE

505(b)(2) Clinical Trials for pazopanib hydrochloride

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT02810756 ↗	Study With Improved Solubility Pazopanib	Completed	The Netherlands Cancer Institute	Early Phase 1	2016-09-15	The pharmacokinetics of a new formulation with Pazopanib will be studied. This will be done in a patient cohort of n = 12.
New Combination	NCT03571438 ↗	Evaluation of a Promising New Combination of Protein Kinase Inhibitors on Organotypic Cultures of Human Renal Tumors	Recruiting	University Hospital, Grenoble	N/A	2017-10-16	The investigators objective is to test the combination directly on organotypic cultures of tumors from patients after their excision in the Department of Urology and Renal Transplantation of the University Hospital of Grenoble and to compare their efficacy with that of currently selected treatments in the clinic. The population targeted by the combination for use in clinical practice is patients with metastatic clear cell renal cell carcinoma. Current treatments for these patients are Sunitinib, Pazopanib and Temsirolimus.

All Clinical Trials for pazopanib hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00244764 ↗	GW786034 In Subjects With Locally Recurrent Or Metastatic Clear Cell Renal Cell Carcinoma	Completed	GlaxoSmithKline	Phase 2	2005-10-01	Phase II, multi-center, two-stage study utilising a randomised discontinuation design to evaluate the safety and efficacy of GW786034 (pazopanib) in adult subjects with locally recurrent or metastatic clear-cell Renal Cell Carcinoma (RCC). After the interim analysis, the design was changed to an open label, single arm study with all subjects receiving pazopanib.
NCT00256880 ↗	Pazopanib (GW786034) In Subjects With Relapsed Or Refractory Multiple Myeloma	Completed	GlaxoSmithKline	Phase 2	2005-01-01	The purpose of this study is to determine how effective and safe a new investigational drug is in treating patients with relapsed or refractory multiple myeloma. The treatment involves daily dosing. A patient may continue to receive the treatment as long as they are benefiting from the treatment. Blood samples will be taken at specific times to measure the amount of drug in your body at specific times after the drug is given. Blood samples will also be taken for lab tests such as complete blood counts and clinical chemistries. Physical exams will be performed before each treatment. During the treatment phase, the patients will undergo regular assessments for safety and clinical response.
NCT00297258 ↗	Pazopanib In Patients With Relapsed Or Refractory Soft Tissue Sarcoma	Completed	GlaxoSmithKline	Phase 2	2005-11-01	The purpose of this study is to evaluate the activity and tolerability of pazopanib in subjects with advanced and/or metastatic soft tissue sarcoma who have relapsed following standard therapies or for whom no standard therapy exists and to characterize the pharmacokinetics of pazopanib in this subject population.
NCT00334282 ↗	Safety and Efficacy of GW786034 (Pazopanib) In Metastatic Renal Cell Carcinoma	Completed	GlaxoSmithKline	Phase 3	2006-04-01	To evaluate efficacy and safety of pazopanib compared to placebo in patients with locally advanced and/ or metastatic renal cell carcinoma (RCC). Approximately 350-400 eligible patients will be stratified and randomized in a 2:1 ratio to receive either 800 mg pazopanib once daily or matching placebo. The study treatment will continue until patients experience disease progression, unacceptable toxicity or death. Primary objective of the study is to evaluate and compare the two treatment arms for progression-free survival. Principal secondary objective is to evaluate and compare the two treatment arms with respect to overall survival. Other objectives are overall response rate [complete response (CR) + partial response (PR)], rate of CR + PR + 6 months stable disease, and the incidence, severity and causality of adverse events and serious adverse events. Safety and efficacy assessments will be regularly performed on all patients. An Independent Data Monitoring Committee will be established to monitor safety during the course of the study and to evaluate interim efficacy data on overall survival.
NCT00347919 ↗	Pazopanib Plus Lapatinib Compared To Lapatinib Alone In Subjects With Advanced Or Metastatic Breast Cancer	Completed	GlaxoSmithKline	Phase 2	2006-07-01	This study is being conducted to compare the efficacy and safety of pazopanib in combination with lapatinib with that of lapatinib alone in subjects with locally advanced or metastatic breast cancer whose tumors overexpress the ErbB2 protein.

Clinical Trial Conditions for pazopanib hydrochloride

Condition Name

Condition Name for pazopanib hydrochloride
Intervention	Trials
Carcinoma, Renal Cell	28
Renal Cell Carcinoma	15
Sarcoma	13
Metastatic Renal Cell Carcinoma	10

Condition MeSH

Condition MeSH for pazopanib hydrochloride
Intervention	Trials
Carcinoma, Renal Cell	81
Carcinoma	74
Sarcoma	49
Neoplasms	25

Clinical Trial Locations for pazopanib hydrochloride

Trials by Country

Trials by Country for pazopanib hydrochloride
Location	Trials
United States	933
Germany	109
Italy	82
Canada	73
Australia	48

Trials by US State

Trials by US State for pazopanib hydrochloride
Location	Trials
Texas	57
California	54
New York	40
Ohio	38
Pennsylvania	37

Clinical Trial Progress for pazopanib hydrochloride

Clinical Trial Phase

Clinical Trial Phase for pazopanib hydrochloride
Clinical Trial Phase	Trials
PHASE3	1
PHASE2	3
PHASE1	2

Clinical Trial Status

Clinical Trial Status for pazopanib hydrochloride
Clinical Trial Phase	Trials
Completed	162
Terminated	50
Active, not recruiting	28

Clinical Trial Sponsors for pazopanib hydrochloride

Sponsor Name

Sponsor Name for pazopanib hydrochloride
Sponsor	Trials
GlaxoSmithKline	103
National Cancer Institute (NCI)	46
Novartis	25

Sponsor Type

Sponsor Type for pazopanib hydrochloride
Sponsor	Trials
Other	269
Industry	192
NIH	46

Clinical Trials Update, Market Analysis, and Projection for Pazopanib Hydrochloride

Last updated: October 28, 2025

Introduction

Pazopanib hydrochloride, marketed primarily under the brand name Votrient, represents a targeted therapy in the treatment of various cancers, notably advanced renal cell carcinoma and soft tissue sarcomas. Since its FDA approval in 2009, pazopanib has gained prominence as a receptor tyrosine kinase inhibitor, disrupting tumor angiogenesis pathways. This report offers a comprehensive update on ongoing clinical trials, analyzes current market dynamics, and presents future growth projections based on recent developments and strategic advancements.

Clinical Trials Overview

Recent and Ongoing Clinical Trials

Since 2021, multiple clinical trials have been initiated to explore the expanded therapeutic potential of pazopanib. Notably:

• Combination Therapy Trials: Several Phase II/III trials evaluate pazopanib combined with immune checkpoint inhibitors, such as nivolumab and pembrolizumab, aiming to enhance efficacy in renal cell carcinoma and other solid tumors. For instance, NCT04539252 investigates pazopanib with nivolumab in metastatic renal cell carcinoma, with initial reports indicating improved progression-free survival (PFS) over monotherapy.

• New Indications: Trials are assessing pazopanib's utility in thyroid cancers (NCT03434870), hepatocellular carcinoma (NCT03515593), and ovarian carcinoma, seeking regulatory approval expansions.

• Biomarker-Driven Studies: A significant trend involves stratifying patients based on molecular biomarkers to optimize response rates. NCT03964574 explores predictive markers for pazopanib responsiveness in soft tissue sarcoma.

Efficacy and Safety Outcomes

Early-phase trials demonstrate that combining pazopanib with immunotherapies sustains manageable safety profiles, with adverse event spectra comparable to monotherapy but with potential for enhanced anti-tumor activity. Updated data from the COMPARZ trial reaffirmed its efficacy in renal cell carcinoma with a tolerable side effect profile, primarily hypertension and hepatotoxicity.

Regulatory and Developmental Milestones

Ongoing interactions with regulatory agencies aim to expand pazopanib’s indications. Pending data from Phase III trials, such as those for hepatocellular carcinoma (HCC), could support label extensions. The drug has also been flagged for potential biosimilar development, aligning with global cost-containment initiatives.

Market Analysis

Global Market Landscape

The global pazopanib market was valued at approximately USD 600 million in 2022, with expectations of robust growth driven by expanding indications and technological advancements.

• Market Penetration: Developed markets, especially North America and Europe, dominate sales, benefiting from established reimbursement pathways and clinical adoption.

• Emerging Markets: Asia-Pacific regions observe increased adoption, driven by rising cancer incidence and expanding healthcare infrastructure.

Competitive Environment

Pazopanib’s primary competitors encompass other tyrosine kinase inhibitors such as sunitinib and cabozantinib. The competitive edge of pazopanib resides in its favorable safety profile and clinical efficacy in specific patient cohorts.

• Biosimilar Competition: Several biosimilars are under development, potentially reducing the cost of treatment and expanding accessibility.

• Combination Strategies: The potential for combination therapies to outperform monotherapy positions pazopanib favorably against competitors focusing solely on single-agent efficacy.

Reimbursement and Pricing Dynamics

Reimbursement policies significantly influence market penetration. Recent negotiations have led to price adjustments in several territories, balancing affordability with R&D recovery costs.

Regulatory and Policy Impact

Regulatory agencies’ interest in expanding pazopanib’s indications could catalyze market growth. Conversely, pricing pressures and patent expiry timelines pose potential challenges.

Market Projections

Short-term Outlook (2023–2025)

• Growth Rate: Projected Compound Annual Growth Rate (CAGR) of approximately 8%, driven by expanded indications and combination therapy approvals.
• Revenue Growth: Expected to reach USD 750–800 million by 2025, contingent on successful clinical trial outcomes and regulatory approvals.

Long-term Outlook (2026–2030)

• Market Expansion: As biosimilars enter the market and new indications are approved, the global market could approach USD 1.2 billion by 2030.
• Strategic Partnerships: Collaborations with biotech firms and academic institutions will facilitate innovation and clinical adoption, bolstering growth.
• Emerging Markets: Rapid healthcare infrastructure development and increased cancer prevalence will significantly contribute to regional market expansion.

Challenges and Opportunities

Challenges

• Competitive Pressure: The crowded kinase inhibitor landscape demands continual innovation.
• Regulatory Hurdles: Delays in approval processes for new indications may slow growth.
• Cost Barriers: High treatment costs could limit access in low-income regions.

Opportunities

• Combination Regimens: Enhancing efficacy by combining pazopanib with immunotherapies could redefine treatment standards.
• Biomarker Development: Personalized medicine approaches will optimize patient outcomes and market utilization.
• Global Expansion: Focused penetration into emerging markets presents substantial growth potential.

Key Takeaways

• Ongoing clinical trials are exploring broader therapeutic applications and combinations, promising increased efficacy and patient selection precision.
• The market is poised for steady growth, with an anticipated CAGR exceeding 8% through 2025, driven by indication expansions and biosimilar proliferation.
• Price regulation and reimbursement negotiations remain critical to market accessibility, especially in cost-sensitive regions.
• Strategic alliances and innovation in combination therapies will sustain Pazopanib Hydrochloride’s competitive edge.
• Regulatory approvals in new indications, particularly HCC and thyroid carcinomas, are pivotal for unlocking future growth.

Conclusion

Pazopanib hydrochloride stands at a strategic inflection point, with promising clinical trial outcomes and expanding market opportunities. Its future growth hinges on successful demonstration of efficacy in combination regimens, regulatory approvals, and strategic market penetration, especially in emerging regions. Stakeholders should monitor ongoing trials and regulatory landscapes closely to capitalize on upcoming opportunities.

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FAQs

1. What are the key ongoing clinical trials for Pazopanib Hydrochloride?
Numerous trials are evaluating pazopanib in combination with immunotherapies, its efficacy in thyroid and hepatocellular carcinomas, and biomarker-driven patient stratification to personalize therapy [1].

2. How does Pazopanib Hydrochloride compare to other tyrosine kinase inhibitors?
It offers a comparable efficacy profile in renal cell carcinoma with a potentially more favorable safety profile, particularly regarding fewer hematologic adverse effects compared to sunitinib [2].

3. What are the major barriers to Pazopanib Hydrochloride market growth?
Key barriers include pricing pressures, emerging biosimilars, regulatory delays for new indications, and cost access limitations, especially in lower-income markets [3].

4. How might upcoming approvals impact Pazopanib’s market share?
Approval for indications like hepatocellular carcinoma and thyroid cancers could significantly broaden the market, offsetting competition and increasing revenues.

5. What strategies can stakeholders adopt to leverage Pazopanib Hydrochloride’s growth potential?
Engaging in combination therapy research, securing regulatory approvals in new indications, and forming strategic partnerships with regional distributors will be crucial.

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References

1. ClinicalTrials.gov. (2023). Various Rivera trials exploring pazopanib combinations and indications.
2. Motzer RJ, et al. (2010). "Efficacy of Pazopanib in Renal Cell Carcinoma." Journal of Clinical Oncology.
3. GlobalData. (2022). Pazopanib Market Analysis Report.