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Last Updated: February 7, 2025

CLINICAL TRIALS PROFILE FOR PAZOPANIB HYDROCHLORIDE


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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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

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.
>Trial ID >Title >Status >Phase >Start Date >Summary

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
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Condition MeSH

Condition MeSH for Pazopanib Hydrochloride
Intervention Trials
Carcinoma, Renal Cell 80
Carcinoma 74
Sarcoma 47
Neoplasms 25
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Clinical Trial Locations for Pazopanib Hydrochloride

Trials by Country

Trials by Country for Pazopanib Hydrochloride
Location Trials
United States 922
Germany 108
Italy 82
Canada 72
Australia 48
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Trials by US State

Trials by US State for Pazopanib Hydrochloride
Location Trials
Texas 57
California 53
New York 40
Pennsylvania 36
Ohio 36
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Clinical Trial Progress for Pazopanib Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Pazopanib Hydrochloride
Clinical Trial Phase Trials
Phase 4 8
Phase 3 16
Phase 2/Phase 3 6
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Clinical Trial Status

Clinical Trial Status for Pazopanib Hydrochloride
Clinical Trial Phase Trials
Completed 162
Terminated 50
Active, not recruiting 28
[disabled in preview] 26
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Clinical Trial Sponsors for Pazopanib Hydrochloride

Sponsor Name

Sponsor Name for Pazopanib Hydrochloride
Sponsor Trials
GlaxoSmithKline 103
National Cancer Institute (NCI) 46
Novartis 25
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Sponsor Type

Sponsor Type for Pazopanib Hydrochloride
Sponsor Trials
Other 265
Industry 188
NIH 46
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Pazopanib Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Pazopanib Hydrochloride

Pazopanib hydrochloride is a potent angiogenesis inhibitor that has been widely studied and used in the treatment of various types of cancer. It works by blocking certain enzymes needed for cell growth and by inhibiting blood flow to tumors, thereby slowing down or stopping the growth of cancer cells.

Clinical Trials Overview

Phase II Trials for Malignant Pheochromocytoma or Paraganglioma

Pazopanib hydrochloride is being investigated in a phase II trial for its efficacy in treating patients with advanced or progressive malignant pheochromocytoma or paraganglioma. This trial aims to determine how well pazopanib hydrochloride works in stopping the growth of tumor cells in these patients. The trial includes participants who have undergone various prior chemotherapeutic or biologic therapies, including anti-angiogenesis therapies such as tyrosine kinase inhibitors[1].

Phase II Trials for Metastatic Kidney Cancer

Another phase II trial is focused on evaluating the effectiveness of pazopanib hydrochloride in treating patients with metastatic non-clear cell kidney cancer. This study examines whether pazopanib hydrochloride can stop the growth of tumor cells by blocking necessary enzymes and blood flow to the tumor[4].

Clinical Trials for Hereditary Hemorrhagic Telangiectasia (HHT)

Pazopanib is also being explored in clinical trials for its potential in treating Hereditary Hemorrhagic Telangiectasia (HHT), a condition characterized by abnormal blood vessel formation. However, as of now, pazopanib has not been approved by the FDA for this indication due to the lack of clinical trial data on its safety and efficacy in HHT patients. Cure HHT is conducting trials and hopes to apply for FDA approval if the results are positive[3].

Market Analysis

Global Market Size and Growth

The global pazopanib hydrochloride API market is experiencing significant growth, driven by several key factors. In 2023, the market size was substantial, and it is projected to grow at a notable compound annual growth rate (CAGR) from 2024 to 2031. The market is segmented based on type, application, and region, with the research segment expected to expand significantly during the forecast period[2].

Market Drivers

  • Advancements in Precision Medicine: The adoption of precision medicine is pushing forward pazopanib's role as a targeted cancer treatment option.
  • Increasing Cancer Incidence: Global increases in cancer incidence rates are driving the demand for effective cancer treatments like pazopanib.
  • Healthcare Infrastructure: Improved healthcare infrastructures in emerging economies are facilitating the diffusion of pazopanib drugs.
  • Government Initiatives: Government initiatives to boost cancer treatment research and innovation support the growth of the pazopanib market[5].

Market Restraints

  • Side Effects and Patient Compliance: Overcoming side effects and ensuring patient compliance are significant challenges in the pazopanib market.
  • Limited Insurance Coverage: Limited insurance coverage curbs the market potential and reach of pazopanib drugs.
  • Patent Cliffs: The challenges posed by patent cliffs can impact the market share of pazopanib[5].

Market Opportunities

  • Strategic Alliances: Fostering strategic alliances with pharmaceutical giants can leverage distribution networks for pazopanib.
  • Untapped Market Segments: Exploring the untapped market segment of rare cancers treatable with pazopanib in regions like Asia presents significant opportunities.
  • Innovation in Drug Delivery: Harnessing innovation in drug delivery methods can optimize the efficacy of pazopanib for patients[5].

Regional Analysis

The global pazopanib hydrochloride API market is analyzed regionally, with detailed insights into market size, share, and growth prospects for each region. The report provides a quantitative and qualitative analysis for each region, helping to understand the key industry segments and their global, regional, and country-level insights[2].

Key Players and Strategies

Companies such as Tecoland and Abcr are focusing on strategy building to strengthen their product portfolios and expand their business in the global market. These companies are investing in research and development to capitalize on the growing demand for pazopanib hydrochloride[2].

Technological Trends and Innovations

The market is driven by technological trends, including advancements in precision medicine and innovations in drug delivery methods. Integrating pazopanib with other cancer therapies that show synergistic effects and exploring personalized medicine approaches are also key areas of focus[5].

Challenges and Future Directions

High Production and Research Costs

One of the significant challenges facing the pazopanib market is the high production and research costs, which impact the pricing strategy of the drug. Addressing these costs while maintaining the drug's efficacy is crucial for its market success[5].

Patient Compliance and Side Effects

Ensuring patient compliance and managing side effects are ongoing challenges. Continuous research and innovation are necessary to optimize the drug's efficacy and minimize its adverse effects.

Key Takeaways

  • Clinical Trials: Pazopanib hydrochloride is being studied in various phase II trials for its efficacy in treating advanced cancers and other conditions.
  • Market Growth: The global pazopanib hydrochloride API market is experiencing significant growth driven by advancements in precision medicine, increasing cancer incidence, and improved healthcare infrastructures.
  • Market Drivers: Key drivers include government initiatives, strategic alliances, and innovations in drug delivery.
  • Challenges: High production costs, limited insurance coverage, and patient compliance issues are significant restraints.
  • Future Directions: The market is expected to grow as companies focus on research, strategic alliances, and optimizing drug delivery methods.

FAQs

Q: What is pazopanib hydrochloride used for?

A: Pazopanib hydrochloride is used primarily in the treatment of various types of cancer, including malignant pheochromocytoma, paraganglioma, and metastatic kidney cancer. It works by inhibiting angiogenesis and blocking necessary enzymes for cell growth.

Q: Is pazopanib approved for treating Hereditary Hemorrhagic Telangiectasia (HHT)?

A: No, pazopanib has not been approved by the FDA for treating HHT as it has not undergone clinical trials for safety and efficacy in HHT patients[3].

Q: What are the key drivers of the pazopanib hydrochloride market?

A: The key drivers include advancements in precision medicine, increasing global cancer incidence rates, improved healthcare infrastructures, and government initiatives to boost cancer treatment research and innovation[5].

Q: What are the main challenges facing the pazopanib hydrochloride market?

A: The main challenges include high production and research costs, limited insurance coverage, patient compliance issues, and the impact of patent cliffs on market share[5].

Q: Which companies are key players in the pazopanib hydrochloride market?

A: Companies such as Tecoland and Abcr are key players, focusing on strategy building and expanding their product portfolios in the global market[2].

Sources

  1. Mayo Clinic: Pazopanib Hydrochloride in Treating Patients with Advanced or Progressive Malignant Pheochromocytoma or Paraganglioma[1].
  2. Cognitive Market Research: Global Pazopanib HCl API Market Report 2024 Edition[2].
  3. CureHHT: Pazopanib Clinical Trial: Q&A[3].
  4. Mayo Clinic: Pazopanib in Treating Patients with Metastatic Non-Clear Cell Kidney Cancer[4].
  5. 360iResearch: Pazopanib Drugs Market Size & Share 2025-2030[5].

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