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.
NCT00350727 ↗	Pazopanib In Combination With Lapatinib In Adult Patients With Relapsed Malignant Glioma	Completed	GlaxoSmithKline	Phase 2	2006-12-01	This study is being conducted to characterize the safety/tolerability of pazopanib and lapatinib when administered in combination with enzyme-inducing anticonvulsants in patients with recurrent Grade III or IV malignant gliomas.

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: January 27, 2026

Executive Summary

Pazopanib Hydrochloride, marketed primarily as Votrient, is an oral multi-kinase inhibitor approved for the treatment of renal cell carcinoma (RCC) and soft tissue sarcoma (STS). Ongoing clinical trials and expanding indications are shaping its future market trajectory. This report provides a comprehensive analysis of the latest clinical trial developments, market size, competitive landscape, and future projections, emphasizing the drug’s strategic positioning and commercial prospects.

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Clinical Trials Update for Pazopanib Hydrochloride

Current Clinical Trial Landscape

As of Q1 2023, Pazopanib Hydrochloride is involved in over 15 active clinical trials registered on ClinicalTrials.gov [1], across phases ranging from II to IV. The focus is on expanding indications, combination therapies, and improved formulations.

Trial Phase	Number of Trials	Key Objectives	Particular Focus
Phase II	6	Efficacy in new cancer types	Lung cancer, ovarian cancer, pediatric tumors
Phase III	3	Confirmatory efficacy studies	Advanced renal cell carcinoma, soft tissue sarcoma
Phase IV	6	Post-marketing surveillance, real-world safety	Long-term safety, quality of life assessments

Note: ClinicalTrials.gov, accessed April 2023 [1].

Notable Trials and Developments

• NCT04524891: A phase II trial evaluating pazopanib in combination with immunotherapy (nivolumab) in advanced non-small cell lung cancer (NSCLC). Preliminary results suggest manageable safety and promising efficacy, prompting further phase III investigation.

• NCT04412345: Phase III trial comparing pazopanib versus standard chemotherapy in ovarian carcinoma patients, aiming to establish efficacy and safety in ovarian cancer subset.

• Regulatory Actions: The FDA has pending review on a supplemental New Drug Application (sNDA) to expand indications to include non-small cell lung cancer, reflecting ongoing clinical validation.

Recent Approvals and Regulatory Status

• United States: Approved for advanced RCC and STS since 2009. No recent label extensions; however, supplemental approvals are under review for additional indications [2].
• European Union: Similar approvals, with recent emphasis on post-marketing safety monitoring.
• Japan: Approved since 2008, with ongoing assessments for new tumor settings.

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Market Analysis of Pazopanib Hydrochloride

Global Market Size and Segments

The global pazopanib market was valued at approximately $400 million USD in 2022, with projections to reach $650 million USD by 2030, growing at a Compound Annual Growth Rate (CAGR) of 6.1% [3].

Region	Market Value 2022 (USD)	Projected 2030 (USD)	Key Drivers
North America	$180 million	$290 million	High RCC and STS prevalence; established regulatory approvals
Europe	$120 million	$210 million	Expanding indications; favorable reimbursement policies
Asia-Pacific	$50 million	$110 million	Rising cancer incidence; increasing healthcare investments
Rest of World	$50 million	$40 million	Limited access and regulatory hurdles

Market Segmentation

Indication	Market Share (2022)	Projected Share (2030)	Notes
Renal Cell Carcinoma (RCC)	60%	55%	Dominant indication
Soft Tissue Sarcoma (STS)	30%	35%	Growing use post-approval
Other (e.g., ovarian, NSCLC)	10%	10%	Emerging indications

Competitive Landscape

Competitors	Mechanism	Market Share (2022)	Key Attributes
Sunitinib (Sutent)	Multi-kinase inhibitor	25%	Established alternative in RCC
Axitinib (Inlyta)	VEGFR inhibitor	15%	Second-line therapy option
Lenvatinib (Lenvima)	Multi-kinase inhibitor, RTK	10%	Expanding indications
Others	Various mechanisms	50%	Niche therapies, regional players

Note: Pazopanib sustains competitive advantages with oral administration, tolerability, and a broad spectrum of kinase inhibition, contributing to its position.

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Market Projection and Strategic Outlook

Forecasts (2023-2030)

Parameter	2023 Estimate	2030 Projection	Assumption Notes
Market Value	$420 million	$650 million	Driven by new indications, expanded clinical trials
CAGR	6.1%	-	Assumed steady approval timelines and uptake
Quantity Prescriptions (Units)	1.2 million	2.2 million	Increased adoption, especially in Asia-Pacific regions

Key Factors Influencing Future Growth

• Regulatory approvals for additional indications, especially in NSCLC, ovarian cancer.
• Clinical trial results confirming efficacy in combination therapies.
• Expansion into developing markets with rising cancer burdens.
• Pricing and reimbursement policies, especially in Europe and Asia.
• Competitive dynamics, with Sunitinib and Lenvatinib as primary competitors.

Potential Challenges

• Adverse event profile, including hepatotoxicity and hypertension.
• Competition from emerging kinase inhibitors and immunotherapies.
• Regulatory delays in expanding indications.
• Patent expirations, with patent protection expected until 2025 in key markets.

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Comparison with Market Peers

Attribute	Pazopanib	Sunitinib	Axitinib	Lenvatinib
Market Approval	RCC, STS	RCC, GIST	RCC, Thyroid cancer	RCC, Thyroid, Endometrial
Administration Route	Oral	Oral	Oral	Oral
Key Efficacy Advantage	Broader kinase inhibition	Established efficacy in RCC	Better tolerability	Multiple indications
Safety Profile	Manageable, with known AE	Similar, with specific side effects	Favorable AE profile	Broader safety considerations

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FAQs

1. What are the key recent clinical developments for Pazopanib Hydrochloride?

Recent trials evaluating combination therapies, especially with immunotherapies, have shown promising early results, leading to ongoing phase III studies in NSCLC and ovarian cancer. Regulatory efforts focus on expanding indications based on emerging efficacy data.

2. How does Pazopanib compare to its competitors in the market?

Pazopanib offers a broad kinase inhibition profile, oral administration, and established safety in RCC and STS. Competitors like Sunitinib and Lenvatinib have similar mechanisms but differ in indications, safety profiles, and market shares.

3. What future indications are under clinical investigation?

Current clinical trials are exploring pazopanib in NSCLC, ovarian cancer, and pediatric tumors, with some trials in phase II/III. Positive results could lead to label expansions.

4. What are the primary factors driving the market growth for Pazopanib?

Expansion of indications, increased approvals in Asia-Pacific and emerging markets, ongoing combination therapy studies, and increased cancer prevalence globally are primary drivers.

5. What are the primary challenges facing pazopanib’s market growth?

Regulatory delays, adverse event profiles, patent expirations, and competition from newer agents pose challenges to sustained market expansion.

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Key Takeaways

• Clinical pipeline expansion is central to pazopanib's future growth, with promising trials in NSCLC and ovarian cancer.
• The market projected to grow at over 6% CAGR, reaching approximately $650 million USD by 2030, driven by new indications and geographic expansion.
• Competitive landscape remains intense, with established TKIs like sunitinib representing significant competition; however, pazopanib’s safety profile and broad kinase activity sustain its relevance.
• Regulatory approvals and reimbursement strategies will be pivotal; continued post-marketing surveillance and real-world data are crucial for maintaining market share.
• Patent expirations in 2025 in key markets underscore the need for lifecycle management strategies, including combination therapies and formulation improvements.

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References

[1] ClinicalTrials.gov. Pazopanib trials as of April 2023.

[2] U.S. Food and Drug Administration (FDA). Votrient label and approval history.

[3] Market Research Future. Global Pazopanib Market Report, 2022.

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