SUTENT (sunitinib malate)
SUTENT is indicated for the treatment of Gastrointestinal stromal tumor (GIST); Advanced renal cell carcinoma (RCC); Adjuvant treatment of renal cell carcinoma (RCC) at high risk of recurrence following nephrectomy; Progressive, well-differentiated pancreatic neuroendocrine tumors (pNET).
How SUTENT Works
Sunitinib functions as a small molecule inhibitor of multiple receptor tyrosine kinases (RTKs) that contribute to tumor growth, pathologic angiogenesis, and metastatic progression. The drug targets several specific receptors, including vascular endothelial growth factor receptors (VEGFR) and platelet-derived growth factor receptors (PDGFR), which are essential for tumor blood supply and cell proliferation. By inhibiting the activity and phosphorylation of these RTKs, sunitinib reduces the growth of tumor cells and prevents the formation of new blood vessels within the tumor environment.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2006-01-26
- Routes
- ORAL
- Dosage Forms
- CAPSULE
SUTENT Approval History
What SUTENT Treats
4 indicationsSUTENT is approved for 4 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Gastrointestinal stromal tumor (GIST)
- Advanced renal cell carcinoma (RCC)
- Adjuvant treatment of renal cell carcinoma (RCC) at high risk of recurrence following nephrectomy
- Progressive, well-differentiated pancreatic neuroendocrine tumors (pNET)
SUTENT Boxed Warning
HEPATOTOXICITY Hepatotoxicity may be severe, and in some cases, fatal. Monitor hepatic function and interrupt, dose reduce, or discontinue SUTENT as recommended [see Warnings and Precautions (5.1) ] . WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning. Hepatotoxicity may be severe, and in some cases fatal. Monitor hepatic function and interrupt, dose reduce, or discontinue SUTENT as recommended [see Warnings and Precautions (5.1) ]....
WARNING: HEPATOTOXICITY Hepatotoxicity may be severe, and in some cases, fatal. Monitor hepatic function and interrupt, dose reduce, or discontinue SUTENT as recommended [see Warnings and Precautions (5.1) ] . WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning. Hepatotoxicity may be severe, and in some cases fatal. Monitor hepatic function and interrupt, dose reduce, or discontinue SUTENT as recommended [see Warnings and Precautions (5.1) ].
SUTENT Target & Pathway
ProTarget
SUTENT Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in SUTENT's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications SUTENT treats. First-in-class if their pivotal trials read out positive.
Clinical Trial Registry
55 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02465060 | NCI-2015-00054 NCI-2015-00054, EAY131 | Ph 2 | active not recruiting | Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) |
| NCT05687123 | NCI-2022-09321 NCI-2022-09321, 202312048 | Ph 1 | recruiting | Testing the Addition of Sunitinib Malate to Lutetium Lu 177 Dotatate (Lutathera) in Pancreatic Neuroendocrine Tumors |
| NCT00814021 | 07URO02 ICREGAUD-07URO02, ICREGAUD-Metastases Cerebrales | Ph 2 | completed | Sunitinib in Treating Patients With Kidney Cancer That Has Spread to the Brain |
| NCT03463460 | OSU-17234 NCI-2018-00192 | Ph 2 | active not recruiting | Pembrolizumab and Sunitinib Malate in Treating Participants With Refractory Metastatic or Unresectable Thymic Cancer |
| NCT02068586 | 13P.377 2013-047, JT 2437 | Ph 2 | active not recruiting | Sunitinib Malate or Valproic Acid in Preventing Metastasis in Patients With High-Risk Uveal Melanoma |
| NCT03541902 | 2017-0725 NCI-2018-01041, 2017-0725 | Ph 2 | active not recruiting | Cabozantinib or Sunitinib Malate in Treating Participants With Metastatic Variant Histology Renal Cell Carcinoma |
| NCT05678673 STELLAR-304 | XL092-304 EU CTR: 2022-501703-27-0 | Ph 3 | active not recruiting | Study of XL092 + Nivolumab vs Sunitinib in Subjects With Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma |
| NCT02761057 results posted | NCI-2015-01707 NCI-2015-01707, S1500 | Ph 2 | completed | Testing Cabozantinib, Crizotinib, Savolitinib and Sunitinib in Kidney Cancer Which Has Progressed |
| NCT00482755 | MA29 CAN-NCIC-MA29, PFIZER-CAN-NCIC-MA29 | Ph 2 | completed | Sunitinib in Treating Patients With Newly Diagnosed Stage II or Stage III Breast Cancer That Can Be Removed by Surgery |
| NCT00673816 VHL3 results posted | 080129 08-EI-0129 | Ph 1, Ph 2 | terminated | Sunitinib Malate to Treat Advanced Eye Disease in Patients With Von Hippel-Lindau Syndrome |
| NCT00813423 | NCI-2012-03112 NCI-2012-03112, CTEP #8342 | Ph 1 | completed | Sunitinib Malate and Hydroxychloroquine in Treating Patients With Advanced Solid Tumors That Have Not Responded to Chemotherapy |
| NCT00520533 results posted | LUD2007-004 | Ph 1 | terminated | Study of Safety and Functional Imaging of cG250 and Sunitinib in Patients With Advanced Renal Cell Carcinoma |
| NCT00936832 | CDR0000637832 FFCD-0801, EUDRACT-2008-005959-19 | Ph 2 | withdrawn | Sunitinib Malate and Combination Chemotherapy as Front-Line Therapy in Treating Patients With Metastatic Rectal Cancer That Cannot Be Removed by Surgery |
| NCT01061411 | I 145508 NCI-2009-01694, I 145508 | Ph 1 | completed | Dalteparin and Sunitinib Malate as First-Line Therapy in Treating Patients With Kidney Cancer That is Metastatic or Cannot Be Removed by Surgery |
| NCT01664182 results posted | NCI-2012-01289 NCI-2012-01289, PHII-122 | Ph 2 | completed | Trebananib With or Without Bevacizumab, Pazopanib Hydrochloride, Sorafenib Tosylate, or Sunitinib Malate in Treating Patients With Advanced Kidney Cancer |
| NCT01164202 SATURNE results posted | PRODIGE 16 FFCD-PRODIGE-16, FFCD-0905 | Ph 2, Ph 3 | completed | Chemoembolization of the Liver With or Without Sunitinib Malate in Treating Patients With Liver Cancer |
| NCT00698815 results posted | NCI-2009-00471 NCI-2009-00471, CDR0000589102 | Ph 2 | completed | Pemetrexed and/or Sunitinib as Second-Line Therapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer |
| NCT01620216 results posted | IRB00007195 NCI-2012-01084, CA180-392 | Ph 2 | terminated | Targeted Therapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia |
| NCT00853125 results posted | 0220080220 P30CA072720, CDR0000635763 | Ph 2 | terminated | Sunitinib and Irradiated Donor Lymphocytes in Treating Patients With Metastatic Kidney Cancer |
| NCT01835158 results posted | NCI-2013-00820 NCI-2013-00820, A031203 | Ph 2 | completed | Cabozantinib-s-malate or Sunitinib Malate in Treating Patients With Previously Untreated Locally Advanced or Metastatic Kidney Cancer |
| NCT01005472 | CDR0000634373 UCLA-0711052, SPRI-P05513 | Ph 1 | completed | Temozolomide and Sunitinib Malate in Treating Patients With Stage III or Stage IV Malignant Melanoma |
| NCT00905021 EXTENT results posted | H 24786 / EXTENT | Ph 1, Ph 2 | terminated | Exemestane With Sunitinib (SUTENT®) in Metastatic Breast Cancer |
| NCT02779283 | IRB00011766 NCI-2016-00083, IRB00011766 | Ph 1 | completed | Personalized Kinase Inhibitor Therapy Combined With Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia |
| NCT00979992 results posted | NCI-2011-03811 NCI-2011-03811, CDR0000654556 | Ph 2 | completed | Sunitinib Malate in Treating Patients With Persistent or Recurrent Clear Cell Ovarian Cancer |
| NCT00693992 results posted | NCI-2009-00469 NCI-2009-00469, CDR0000597649 | Ph 3 | completed | Sunitinib Malate as Maintenance Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Previously Treated With Combination Chemotherapy |
| NCT01118351 results posted | CASE3808 NCI-2010-01137, CASE 3808-CC530 | Ph 2 | terminated | Sunitinib Malate in Treating Patients With Recurrent Transitional Cell Bladder Cancer |
| NCT01396148 results posted | A6181196 2011-002008-33 | Ph 2 | completed | A Study of Sunitinib In Young Patients With Advanced Gastrointestinal Stromal Tumor |
| NCT01089088 | CDR0000667764 WCTU-SUCCINCT, ISRCTN54607216 | Ph 2 | completed | Gemcitabine Hydrochloride, Cisplatin, and Sunitinib Malate as First-Line Therapy in Treating Patients With Locally Advanced And/or Metastatic Transitional Cell Carcinoma of the Urothelium (SUCCINCT) |
| NCT00864721 results posted | 06-135 GA6181UU | Ph 2 | completed | Sunitinib Non Small Cell Lung Cancer Patients Over 70 |
| NCT01158222 results posted | CASE8809 NCI-2010-01391 | Ph 2 | completed | Sunitinib Malate in Treating Patients With Previously Untreated Metastatic Kidney Cancer |
| NCT00748163 | 2007LS098 0802M26201, ABX080 | Ph 2 | withdrawn | Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Sunitinib as First-Line Therapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer |
| NCT00953459 | EORTC-08061 EU-20910, 2006-002485-19 | Ph 2 | terminated | Sunitinib Malate in Treating Patients With Small Cell Lung Cancer |
| NCT00891878 results posted | NCCTG-N0747 NCI-2011-01920, CDR0000641212 | Ph 2 | completed | Capecitabine With or Without Sunitinib Malate as First-Line Therapy in Treating Patients With Metastatic Cancer of the Esophagus or Gastroesophageal Junction |
| NCT02626754 | 2014-10-002A | Ph 2 | terminated | A Prospective Study on Sunitinib as First Line Therapy for Advanced/Metastatic Renal Cell Carcinoma in Asian Population |
| NCT00824538 results posted | 077539 077539 | Ph 2 | terminated | Sunitinib in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer Who Have Tumor Cells in the Bone Marrow |
| NCT00787787 results posted | 6553 NCI-2010-00605 | Ph 2 | terminated | Sunitinib Malate and Capecitabine in Treating Patients With Unresectable or Metastatic Liver Cancer |
| NCT00702884 results posted | OSU-07121 NCI-2011-03148 | Ph 2 | completed | Sunitinib in Treating Patients With Relapsed or Refractory Esophageal or Gastroesophageal Junction Cancer |
| NCT00730353 results posted | HOG GI06-112 | Ph 2 | completed | Sutent + Taxol for Advanced Esophageal Cancer |
| NCT00879619 results posted | UCI 07-64 2008-6187, NCI-2010-00216 | Ph 1, Ph 2 | terminated | Taxotere/Prednisone Plus Sunitinib in Chemotherapy-Naïve, Hormone Refractory Prostate Cancer Patients |
| NCT00912912 results posted | 2006-0685 NCI-2012-01645 | Ph 2 | terminated | Sunitinib Malate in Refractory Germ Cell Tumors |
| NCT00859339 results posted | HOG GU07-123 | Ph 2 | terminated | Neoadjuvant Cisplatin, Gemcitabine, Sunitinib Malate + Radical Cystectomy for TCC |
| NCT00747305 | CDR0000612590 MUSC-101219 | Ph 1 | terminated | Sunitinib Before and After Surgery in Treating Patients With Metastatic Kidney Cancer That Can Be Removed By Surgery |
| NCT01462695 results posted | NCI-2011-03536 NCI-2011-03536, CDR0000712861 | Ph 2 | completed | Sunitinib Malate in Treating Younger Patients With Recurrent, Refractory, or Progressive Malignant Glioma or Ependymoma |
| NCT01215578 NET | P070145 2007-005628-34 | Ph 2 | terminated | Predictive Biomarkers of Response to Sunitinib in the Treatment of Poorly-differentiated NEURO-Endocrine Tumors |
| NCT00631527 | 2006-0684 NCI-2010-01524 | Ph 1 | completed | Sunitinib Malate, Hormone Ablation and Radiation Therapy in Patients With Prostate Cancer |
| NCT00910039 results posted | CASE1308 P30CA043703, CASE1308 | Ph 2 | terminated | Sunitinib Malate After Stereotactic Radiosurgery in Treating Patients With Newly Diagnosed Brain Metastases |
| NCT00521092 | NCI-2009-00229 NCI-2009-00229, CASE 1706 - AMC 049 | Ph 2 | withdrawn | Sunitinib Malate in Treating East African Patients With Kaposi Sarcoma |
| NCT01243359 | NCI-2013-00764 NCI-2013-00764, CDR0000688559 | Ph 1 | completed | Sunitinib Malate and Bevacizumab in Treating Patients With Kidney Cancer or Advanced Solid Malignancies |
| NCT00890747 | NCI-2012-02208 NCI-2012-02208, AMC-061 | Ph 1 | completed | Sunitinib Malate in Treating HIV-Positive Patients With Cancer Receiving Antiretroviral Therapy |
| NCT01215565 Fibrolam | P070134 2008-003423-23 | Ph 2 | terminated | Study of Sunitinib in Patients With Advanced/Inoperable Fibrolamellar Carcinoma |
Showing 50 of 55 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SUTENT FDA Label Details
Indications & Usage
FDA Label (PDF)SUTENT is indicated for the treatment of Gastrointestinal stromal tumor (GIST); Advanced renal cell carcinoma (RCC); Adjuvant treatment of renal cell carcinoma (RCC) at high risk of recurrence following nephrectomy; Progressive, well-differentiated pancreatic neuroendocrine tumors (pNET).
WARNING: HEPATOTOXICITY Hepatotoxicity may be severe, and in some cases, fatal. Monitor hepatic function and interrupt, dose reduce, or discontinue SUTENT as recommended [see Warnings and Precautions (5.1) ] . WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning. Hepat...
Track SUTENT with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment