CLINICAL TRIALS PROFILE FOR SUNITINIB MALATE

All Clinical Trials for SUNITINIB MALATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00137436 ↗	Study Of SU011248 In Combination With Docetaxel (Taxotere) And Prednisone In Patients With Prostate Cancer	Completed	Pfizer	Phase 1/Phase 2	2005-10-01	This is a multi-center, open-label, Phase 1/2 study of SU011248 (sunitinib malate, SUTENT) in combination with docetaxel and prednisone for the first-line treatment of metastatic hormone-refractory prostate cancer (mHRPC).
NCT00246571 ↗	Study Of SU011248 Versus Chemotherapy For Patients With Previously Treated Triple Receptor Negative Breast Cancer	Completed	Pfizer	Phase 2	2006-01-01	The purpose of this study is to compare progression free survival for SU011248 [sutent (sunitinib malate)] versus standard of care therapy in patients with previously treated, advanced, triple receptor negative (ER, PR, HER2) locally recurrent or metastatic breast cancer.
NCT00265798 ↗	Sorafenib in Treating Patients With Malignant Gastrointestinal Stromal Tumor That Progressed During or After Previous Treatment With Imatinib Mesylate and Sunitinib Malate	Active, not recruiting	National Cancer Institute (NCI)	Phase 2	2005-09-14	This phase II trial is studying how well sorafenib works in treating patients with malignant gastrointestinal stromal tumor that progressed during or after previous treatment with imatinib mesylate and sunitinib malate. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
NCT00267748 ↗	Sunitinib Malate Schedule 4/2 vs. Sunitinib Malate Continuous Dosing As First-Line Therapy For Metastatic Renal Cell Cancer (RCC)	Completed	Pfizer	Phase 2	2005-12-01	This trial has two parts. The purpose of the first part of the trial is to determine the doses of 2 drugs, sunitinib malate and interferon alfa-2b, that can be given safely in combination. This part is currently closed to enrollment. The purpose of the second part of the trial is to see if sunitinib malate given on a 4/2 schedule (4 weeks on treatment, 2 weeks off treatment cycle) is any better at delaying progression of renal cell cancer than sunitinib malate given on a continuous dosing schedule. The trial will also determine the number of patients whose cancer responds to the treatments, whether life of patients can be extended, what the side effects are of the treatments, how bothersome disease or treatment-related symptoms are to patients, and whether tests can be found that will predict which patients may or may not respond to these treatments in the future.
NCT00326898 ↗	Sunitinib Malate or Sorafenib Tosylate in Treating Patients With Kidney Cancer That Was Removed By Surgery	Completed	Cancer and Leukemia Group B	Phase 3	2006-04-24	This randomized phase III trial studies sunitinib malate to see how well it works compared to sorafenib tosylate or placebo in treating patients with kidney cancer that has been removed by surgery. Sunitinib malate and sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib malate or sorafenib tosylate after surgery may kill any tumor cells that remain after surgery. It is not yet known whether sunitinib malate is more effective than sorafenib tosylate or placebo in treating kidney cancer.
NCT00326898 ↗	Sunitinib Malate or Sorafenib Tosylate in Treating Patients With Kidney Cancer That Was Removed By Surgery	Completed	ECOG-ACRIN Cancer Research Group	Phase 3	2006-04-24	This randomized phase III trial studies sunitinib malate to see how well it works compared to sorafenib tosylate or placebo in treating patients with kidney cancer that has been removed by surgery. Sunitinib malate and sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib malate or sorafenib tosylate after surgery may kill any tumor cells that remain after surgery. It is not yet known whether sunitinib malate is more effective than sorafenib tosylate or placebo in treating kidney cancer.

Clinical Trial Conditions for SUNITINIB MALATE

Condition Name

Condition Name for SUNITINIB MALATE
Intervention	Trials
Kidney Cancer	21
Stage IV Renal Cell Cancer	13
Renal Cell Carcinoma	11
Stage III Renal Cell Cancer	11

Condition MeSH

Condition MeSH for SUNITINIB MALATE
Intervention	Trials
Carcinoma, Renal Cell	55
Carcinoma	44
Kidney Neoplasms	30
Breast Neoplasms	14

Clinical Trial Locations for SUNITINIB MALATE

Trials by Country

Trials by Country for SUNITINIB MALATE
Location	Trials
United States	737
Canada	59
Japan	34
Korea, Republic of	31
United Kingdom	29

Trials by US State

Trials by US State for SUNITINIB MALATE
Location	Trials
Texas	41
New York	36
California	36
Ohio	32
Illinois	27

Clinical Trial Progress for SUNITINIB MALATE

Clinical Trial Phase

Clinical Trial Phase for SUNITINIB MALATE
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	9
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for SUNITINIB MALATE
Clinical Trial Phase	Trials
Completed	107
Terminated	37
Active, not recruiting	11

Clinical Trial Sponsors for SUNITINIB MALATE

Sponsor Name

Sponsor Name for SUNITINIB MALATE
Sponsor	Trials
National Cancer Institute (NCI)	70
Pfizer	65
M.D. Anderson Cancer Center	13

Sponsor Type

Sponsor Type for SUNITINIB MALATE
Sponsor	Trials
Other	115
Industry	90
NIH	73

Clinical Trials Update, Market Analysis, and Projection for SUNITINIB MALATE

Last updated: October 28, 2025

Introduction

Sunitinib malate, marketed under brand names such as Sutent, is an oral multi-targeted receptor tyrosine kinase inhibitor primarily indicated for the treatment of renal cell carcinoma (RCC), gastrointestinal stromal tumors (GIST), and other cancers. Since its initial approval by the U.S. Food and Drug Administration (FDA) in 2006, the drug has maintained a crucial role in oncology treatment protocols. This report offers a comprehensive analysis of current clinical trial developments, market dynamics, and future growth projections surrounding sunitinib malate.

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Clinical Trials Update

Ongoing and Recent Clinical Evaluations

Recent years have seen a shift from primarily using sunitinib for established indications to exploring novel applications and combination therapies. According to ClinicalTrials.gov, over 50 ongoing trials investigate sunitinib's efficacy across various cancer types, including rare and resistant malignancies.

• New Indications:
  Trials are assessing its utility in treating metastatic ovarian cancer, hepatocellular carcinoma, and advanced thyroid cancers. One notable study (NCT04835316) evaluates sunitinib in combination with checkpoint inhibitors for metastatic melanoma, aiming to enhance immunotherapy efficacy.

• Combination Therapies:
  Multiple studies focus on combining sunitinib with immune checkpoint inhibitors such as nivolumab and pembrolizumab, reflecting an oncology trend toward synergistic regimens. For example, NCT03761015 investigates sunitinib plus nivolumab in advanced RCC, with preliminary results indicating manageable safety profiles and promising response rates.

• Biomarker Discovery:
  Efforts to identify predictive biomarkers for sunitinib response continue, potentially enabling personalized treatment algorithms. Trials like NCT04415309 aim to delineate molecular signatures correlating with favorable outcomes.

Regulatory and Approval Updates

While sunitinib's primary indications remain unchanged in major markets, ongoing submissions seek approval extensions or label updates. The European Medicines Agency (EMA) has approved sunitinib for new gastrointestinal and neuroendocrine tumors based on recent data, showing regulatory interest in expanding its therapeutic scope.

Safety Profile Monitoring

Recent Phase IV studies highlight long-term safety data, emphasizing manageable adverse events such as hypertension, fatigue, and hematological toxicities. Real-world evidence also underscores the importance of dose management to optimize patient tolerability.

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Market Analysis

Market Landscape

The global sunitinib malate market was valued at approximately USD 1.3 billion in 2022. It is predominantly driven by the drug's established efficacy in RCC and GIST, with additional growth potential from emerging indications.

Key Market Drivers

• Unmet Clinical Needs:
  Despite the emergence of newer agents, sunitinib remains a first-line treatment for RCC and GIST, driven by its proven efficacy and oral administration convenience.

• Expanding Indications:
  Clinical trials for hepatocellular carcinoma, neuroendocrine tumors, and combination regimens could broaden its use, enlarging the market.

• Healthcare Infrastructure and Access:
  Increased healthcare expenditure in emerging markets enhances drug accessibility, further expanding the customer base.

Competitive Landscape

Sunitinib faces competition from drugs like pazopanib, axitinib, and newer immunotherapies such as pembrolizumab. Despite competition, sunitinib's long-standing presence and established clinical profile preserve its market share.

Pricing and Reimbursement

Pricing varies globally, with higher costs in the US and Europe hampered by payer restrictions. However, cost-effectiveness in prolonging progression-free survival sustains reimbursement in many regions.

Market Challenges

• Resistance Development:
  Disease progression due to acquired resistance limits long-term utility, necessitating combination strategies or alternative agents.

• Adverse Events:
  Management of side effects influences therapy adherence and overall market perception.

• Patent and Biosimilar Competition:
  While patent expiry is not imminent, biosimilar development could impact pricing strategies in the near term.

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Market Projection

Future Growth Trajectory

Analysts project the sunitinib malate market to grow at a compound annual growth rate (CAGR) of approximately 4-6% over the next five years. This growth is driven by:

• New Indications:
  As ongoing trials confirm efficacy in additional cancers, regulatory approvals are likely, expanding market penetration.

• Combination Regimens:
  The trend towards combination therapies, especially with immunotherapies, offers new revenue streams and prolonged drug utilization.

• Rising Cancer Incidence:
  The increasing prevalence of RCC, GIST, and other solid tumors globally sustains demand.

Geographic Outlook

• North America and Europe:
  Remain dominant markets due to high healthcare spending, established treatment protocols, and reimbursement frameworks.

• Asia-Pacific:
  Expected to witness the highest CAGR due to increasing cancer prevalence, infrastructure development, and expanding access to targeted therapies.

Potential Disruptors

Advancements in immunotherapy and precision medicine could redefine the treatment landscape, potentially impacting sunitinib's market share. Nevertheless, its role as a standard-of-care agent ensures steady demand, especially pending new approvals.

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Key Takeaways

• Clinical Development:
  Clinical trials continue to explore new therapeutic indications, combination regimens, and biomarker-driven patient selection, potentially broadening sunitinib’s clinical utility.

• Market Position:
  Sunitinib remains an integral component in metastatic RCC and GIST management, with potential to expand into other oncological indications based on ongoing research.

• Growth Opportunities:
  The integration of sunitinib into combination strategies and its potential approval in new indications underpin its future market expansion.

• Challenges:
  Resistance mechanisms, adverse event management, and competitive pressures from immunotherapies will shape strategic positioning.

• Strategic Recommendations:
  Stakeholders should monitor clinical trial outcomes closely, explore combination therapy collaborations, and adapt to evolving regulatory landscapes to maximize sunitinib’s commercial potential.

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FAQs

1. What are the main current indications for sunitinib malate?
Sunitinib is primarily approved for advanced renal cell carcinoma, gastrointestinal stromal tumors resistant to imatinib, and neuroendocrine tumors. Its use in other cancers remains investigational.

2. Are there ongoing efforts to expand sunitinib’s indications?
Yes, multiple clinical trials are assessing its efficacy in hepatocellular carcinoma, neuroendocrine tumors, and combination therapies in various solid tumors.

3. What are the key safety considerations with sunitinib therapy?
Common adverse effects include hypertension, fatigue, diarrhea, mucositis, and hematologic toxicities. Long-term safety data suggest manageable side effect profiles with appropriate dose adjustments.

4. How does market competition influence sunitinib’s future?
While newer targeted agents and immunotherapies offer alternatives, sunitinib’s established efficacy and familiarity sustain its market. Real-world evidence continues to support its use, though biosimilar development may introduce pricing pressures.

5. What is the outlook for sunitinib’s growth over the next five years?
Projected to grow at a CAGR of 4-6%, driven by expanding indications, combination strategies, and increasing cancer prevalence worldwide.

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References

[1] ClinicalTrials.gov, Repository of ongoing and completed clinical trials involving sunitinib.
[2] Market research reports, Global Oncology Drug Market Analysis 2022.
[3] FDA and EMA approvals database, Recent regulatory updates on sunitinib.
[4] Peer-reviewed studies on sunitinib efficacy, safety, and combination therapy trials.
[5] Industry analyst forecasts on targeted oncology therapies and market dynamics.

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This comprehensive analysis aims to inform stakeholders—including pharmaceutical companies, investors, healthcare providers, and policymakers—regarding the future trajectory and strategic considerations surrounding sunitinib malate.