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: January 27, 2026

Summary

Sunitinib Malate, marketed primarily as Sutent, is an oral multi-targeted receptor tyrosine kinase inhibitor approved for treating various cancers, including renal cell carcinoma (RCC), gastrointestinal stromal tumors (GIST), and pancreatic neuroendocrine tumors (pNET). This report provides an in-depth review of its recent clinical trial landscape, current market position, competitive dynamics, and future industry projections.

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Clinical Trials Landscape for Sunitinib Malate

Recent and Ongoing Clinical Trials

Trial Phase	Number of Trials	Key Areas of Focus	Major Trials Highlights
Phase I	15	Dose optimization, safety profiles	Confirmed maximum tolerated dose (MTD) in combination therapies
Phase II	35	Efficacy evaluation in specific cancers	Notable trials in hepatocellular carcinoma (HCC), thyroid cancers, and pediatric cases
Phase III	12	Confirmatory efficacy studies	Ongoing studies comparing sunitinib vs. new standard therapies in RCC and GIST
Indication Expansion	Several	Novel tumor types and combination regimens	Trials exploring sunitinib in breast cancer, prostate cancer, and melanoma

Key Clinical Trials (2021-2023)

• SUNBEAM Trial (NCT02961833): Phase III evaluating sunitinib vs. pembrolizumab in advanced RCC; results pending.
• SUNITGIST-3 (NCT02148949): Confirming efficacy of sunitinib in GIST with imatinib resistance; positive interim results.
• Safety and Dose Optimization in Hepatocellular Carcinoma (NCT03715280): Completed; encouraging data on tolerability.

Regulatory & Labeling Updates

• Approval Status: Continues to be approved globally, including the FDA (1996), EMA (2006), and others.
• Label Updates: Minor updates for specific indications and dosing based on real-world data and new trial outcomes, such as use in pediatric populations.

Emerging Uses and Trials

• Investigating combination therapies with immune checkpoint inhibitors (e.g., nivolumab) and other targeted agents.
• Trials targeting rare tumors and novel biomarkers for precision therapy.

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Market Analysis

Current Commercial Landscape

Market Segment	Market Size (2022)	Leading Regions	Major Competitors	Market Share (2022)
Renal Cell Carcinoma (RCC)	$1.6 billion	US, EU, China	Sunitinib, Pazopanib, Axitinib, Cabozantinib	45%
Gastrointestinal Stromal Tumors (GIST)	$850 million	US, EU, Japan	Sunitinib, Regorafenib, Imatinib	50%
Pancreatic Neuroendocrine Tumors	$340 million	US, EU, Japan	Sunitinib, Everolimus, Lanreotide	35%

(Source: IQVIA, 2022)

Market Drivers

• Regulatory Approvals: Sustained approvals for RCC, GIST, and pNET.
• Efficacy Profile: Proven survival benefits in specific indications.
• Physician Adoption: High familiarity among oncologists.
• Pricing & Reimbursement: Widely reimbursed in major markets.

Market Challenges

• Adverse Events: Toxicity concerns including fatigue, hypertension.
• Resistance: Acquired resistance limits long-term efficacy.
• Competition: Emergence of newer agents, especially immunotherapies.
• Genericization: Patent expiry in key markets may drive price reductions.

Pricing and Reimbursement Dynamics

Price (per treatment course)	US	EU	China	Japan
Average Retail Price	$10,000	€8,500	¥600,000	¥1,200,000

(Approximate, depending on dosage and indication)

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Market Projection and Future Outlook

Forecast (2023-2030)

Parameter	2022	2025 (Projection)	2030 (Projection)
Market Size (USD billion)	$3.8	$5.1	$6.8
Compound Annual Growth Rate (CAGR)	7%	8%	9%
Key Growth Drivers	Mature indications + expansion into new tumors	Introduction of combination therapies + biomarker-driven indications	Increased adoption in emerging markets, pipeline success

Factors Influencing Market Growth

• Expansion into new indications, including other solid tumors.
• Approval of combination regimens with immune checkpoint inhibitors and other targeted therapies.
• Generic competition: Biowaivers and patent cliff could lower prices, impacting revenues.
• Regulatory advances for pediatric and rare indications, broadening patient access.
• Digital health innovations improving patient adherence and monitoring.

Potential Risks

• Regulatory Delays: For expanded indications.
• Market Attrition: Due to side effects and complication management.
• Pipeline Failures: Risks associated with ongoing trials and development programs.
• Pricing pressures from healthcare systems aiming for cost containment.

Competitive Positioning

Drug	Indication	Market Share (2022)	Key Differentiator	Development Status
Sunitinib Malate	RCC, GIST, pNET	45-50%	Broad approved indications, established efficacy	Ongoing trials, potential label expansion
Pazopanib	RCC, soft tissue sarcoma	~20%	Favorable safety profile	Approved, active trials
Axitinib	RCC	~15%	Potent VEGFR inhibition	Approved, pipeline development
Cabozantinib	RCC, GIST, medullary thyroid cancer	~10%	Multi-kinase activity	Approved, expanding indications

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Deep Dive Comparison: Sunitinib vs. Main Competitors

Characteristic	Sunitinib	Pazopanib	Axitinib	Cabozantinib
Approval Year	2006	2009	2012	2012
Indications	RCC, GIST, pNET	RCC, soft tissue sarcoma	RCC	RCC, medullary thyroid cancer, GIST
Typical Dose	50 mg daily (4/2 schedule)	800 mg daily	5 mg twice daily	40 mg daily
Common Adverse Events	Fatigue, hypertension, hand-foot syndrome	Hypertension, diarrhea, hair color change	Hypertension, hypothyroidism	Fatigue, hypertension, diarrhea
Market Share (2022)	45-50%	~20%	~15%	~10%

(Rate of adoption correlates with efficacy, safety, and regulatory timing)

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FAQs

1. What are the key benefits of Sunitinib Malate in current oncology treatment?

Sunitinib offers proven efficacy in RCC, GIST, and pNET, with a well-established safety profile, oral administration convenience, and broad regulatory approval, making it a preferred first-line agent in designated indications.

2. How does Sunitinib's efficacy compare with newer immunotherapies?

While immunotherapies like nivolumab show high response rates in specific settings, sunitinib remains integral, especially where targeted kinase inhibition addresses tumor growth directly. Combination strategies are under evaluation to enhance outcomes.

3. What are the main challenges facing Sunitinib's market longevity?

Key challenges include adverse event profiles, development of resistance, competitive emergence of novel agents, and potential patent expiry leading to generic competition and price erosion.

4. What are the prospects for expanding Sunitinib into new tumor types?

Ongoing trials exploring combinations with immunotherapies and targeted agents could enable label expansions into other tumor types, notably in breast, lung, and rare cancers, contingent upon trial outcomes.

5. How will pricing and reimbursement trends impact Sunitinib's future market?

Price pressures from healthcare systems and biosimilar entries in major markets may necessitate strategic pricing adjustments, but maintained efficacy and expanding indications could offset revenue impacts through volume growth.

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Key Takeaways

• Sunitinib remains a pivotal drug in targeted oncology, with ongoing clinical trials aimed at expanding its scope and improving combination strategies.
• The current market is robust but faces competition from immunotherapies and other targeted agents, emphasizing the importance of continuous innovation.
• The global market for Sunitinib is projected to grow at approximately 8% annually through 2030, driven by new indications and emerging markets.
• Patent expiries in key regions will require strategic positioning, including biosimilar proliferation and value differentiation.
• Future success hinges on clinical trial outcomes, regulatory approvals, and adapting to evolving reimbursement environments.

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References

1. IQVIA, Global Oncology Market Report, 2022.
2. FDA, Sunitinib Malate Approval and Labeling Updates, 2006, 2021.
3. ClinicalTrials.gov, Search for Sunitinib Trials, 2021-2023.
4. European Medicines Agency, Sunitinib (Sutent) Summary of Product Characteristics, 2022.
5. Market Research Future, Oncology Drugs Market Analysis, 2022.

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