SUNITINIB MALATE
SUNITINIB MALATE is indicated for the treatment of Gastrointestinal Stromal Tumor; Renal Cell Carcinoma; Pancreatic Neuroendocrine Tumor.
How SUNITINIB MALATE Works
Sunitinib is a small-molecule inhibitor of multiple receptor tyrosine kinases (RTKs) implicated in tumor growth, pathologic angiogenesis, and metastatic progression. It targets platelet-derived growth factor receptors (PDGFRα and PDGFRβ), vascular endothelial growth factor receptors (VEGFR1, VEGFR2, and VEGFR3), stem cell factor receptor (KIT), Fms-like tyrosine kinase-3 (FLT3), colony-stimulating factor receptor Type 1 (CSF-1R), and the glial cell-line derived neurotrophic factor receptor (RET). By inhibiting these signaling pathways, sunitinib suppresses tumor cell proliferation and inhibits tumor angiogenesis.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2021-08-16
- Routes
- ORAL
- Dosage Forms
- CAPSULE
SUNITINIB MALATE Approval History
What SUNITINIB MALATE Treats
3 indicationsSUNITINIB MALATE is approved for 3 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Gastrointestinal Stromal Tumor
- Renal Cell Carcinoma
- Pancreatic Neuroendocrine Tumor
SUNITINIB MALATE Boxed Warning
HEPATOTOXICITY Hepatotoxicity may be severe, and in some cases, fatal. Monitor hepatic function and interrupt, dose reduce, or discontinue sunitinib malate capsules 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 sunitinib malate capsules as recommended [see Warnings and Precautions ...
WARNING: HEPATOTOXICITY Hepatotoxicity may be severe, and in some cases, fatal. Monitor hepatic function and interrupt, dose reduce, or discontinue sunitinib malate capsules 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 sunitinib malate capsules as recommended [see Warnings and Precautions ( 5.1) ].
SUNITINIB MALATE Target & Pathway
ProTarget
SUNITINIB MALATE 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 SUNITINIB MALATE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications SUNITINIB MALATE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to SUNITINIB MALATE
3 of 17FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
183 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) |
| NCT05773274 | NCI-2023-00118 NCI-2023-00118, CCTG-NE1 | Ph 2 | recruiting | Comparing Retreatment of 177Lu-DOTATATE PRRT Versus the Usual Treatment in Patients With Metastatic Unresectable Gastroenteropancreatic Neuroendocrine Tumors, NET RETREAT 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 |
| NCT06390826 results posted | NCI-2024-01135 NCI-2024-01135, EAY131-V | Ph 2 | active not recruiting | Testing Sunitinib as Potentially Targeted Treatment in Cancers With cKIT Genetic Changes (MATCH - Subprotocol V) |
| NCT03768063 IMbrella B | BO40729 2023-506184-34-00 | Ph 3 | active not recruiting | A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study |
| NCT00814021 | 07URO02 ICREGAUD-07URO02, ICREGAUD-Metastases Cerebrales | Ph 2 | completed | Sunitinib in Treating Patients With Kidney Cancer That Has Spread to the Brain |
| NCT03091192 results posted | D5082C00003 2016-004108-73 | Ph 3 | active not recruiting | Savolitinib vs. Sunitinib in MET-driven PRCC. |
| NCT07218926 | 300383 2025-522229-37-00 | Ph 3 | recruiting | A Study of IDRX-42 (GSK6042981) Versus (vs) Sunitinib in Participants With Gastrointestinal Stromal Tumors After Imatinib Therapy |
| NCT04633122 results posted | ZL-2307-003 | Ph 2 | completed | A Study to Assess DCC-2618 and Sunitinib in Patients With Advanced GIST After Treatment With Imatinib |
| NCT02693535 TAPUR | Pro00014171 | Ph 2 | recruiting | TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer |
| NCT03899155 | CA209-8TT 2018-004362-34 | Ph 2 | recruiting | Pan Tumor Rollover Study |
| NCT02555748 SUP-R | 14 URO 06 | Ph 4 | completed | Therapeutic Drug Monitoring of Sunitinib and Pazopanib in Advanced or Metastatic Renal Cell Carcinoma |
| NCT05477576 ACTION-1 | RYZ101-301 | Ph 3 | recruiting | Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy |
| NCT03297606 CAPTUR | PM1 ESR-17-12831, CA209-9DL | Ph 2 | recruiting | Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR) |
| NCT01396408 | I206 | Ph 2 | active not recruiting | A Phase II Study of Sunitinib or Temsirolimus in Patients With Advanced Rare Tumours |
| NCT05024214 | KN035-CN-010 | Ph 1, Ph 2 | recruiting | Phase Ib/II Trial of Envafolimab Plus Lenvatinib for Subjects With Solid Tumors |
| 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 |
| NCT07477457 | 25-257 | Ph 2 | recruiting | A Study of Gefitinib, Trametinib, Disulfiram, and Sunitinib in Addition to Standard Chemotherapy in People With Osteosarcoma |
| 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 |
| NCT02811861 CLEAR results posted | E7080-G000-307 KEYNOTE-581, 2016-000916-14 | Ph 3 | active not recruiting | Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma |
| NCT03673501 INTRIGUE results posted | DCC-2618-03-002 | Ph 3 | active not recruiting | A Study of Ripretinib vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib |
| NCT05208047 | CGT9486-21-301 | Ph 3 | active not recruiting | (Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors |
| NCT03900793 | 18-2740.cc NCI-2019-06119 | Ph 1 | recruiting | Losartan + Sunitinib in Treatment of Osteosarcoma |
| NCT01391962 results posted | 110200 11-C-0200 | Ph 2 | completed | Sunitinib or Cediranib for Alveolar Soft Part Sarcoma |
| NCT02853331 results posted | 3475-426 163460, MK-3475-426 | Ph 3 | completed | Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Axitinib Versus Sunitinib Monotherapy in Participants With Renal Cell Carcinoma (MK-3475-426/KEYNOTE-426) |
| NCT05245968 | 10058060 | Ph 1 | active not recruiting | A Study of Pimitespib in Combination With Imatinib in Patients With GIST (CHAPTER-GIST-101) |
| 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 |
| NCT00715442 | 2007-0511 NCI-2012-01678 | Ph 2 | active not recruiting | Pre-Surgical Sutent in Renal Cell Carcinoma (RCC) |
| NCT05734105 INSIGHT | DCC-2618-03-003 2022-503058-37-00 | Ph 3 | active not recruiting | A Study of Ripretinib vs Sunitinib in Patients With Advanced GIST With Specific KIT Exon Mutations Who Were Previously Treated With Imatinib |
| NCT04394975 | JS001-036-Ⅲ-RCC | Ph 3 | completed | Study to Evaluate the Efficacy and Safety of Toripalimab in Combination With Axitinib Versus Sunitinib Monotherapy in Advanced Renal Cell Cancer |
| NCT07165418 | 2025YJZ61 | Ph 3 | not yet recruiting | A Comparison of Vorolanib Tablets Combined With Everolimus Versus Sunitinib in Patients With Advanced Renal Cell Carcinoma Who Have Progressed After Treatment With Immunotherapy Monotherapy or in Combination With TKI |
| NCT05366816 | 20201368 | Ph 2 | recruiting | ctDNA-Guided Sunitinib And Regorafenib Therapy for GIST |
| NCT02684006 results posted | B9991003 2015-002429-20, JAVELIN RENAL 101 | Ph 3 | completed | A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101) |
| NCT03260894 results posted | KEYNOTE-679/ECHO-302 2024-512016-22-00, 2017-002259-26 | Ph 3 | completed | Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care in mRCC (KEYNOTE-679/ECHO-302) |
| 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 |
| NCT01286896 | M10PKS 2010-021454-20 | Ph 1 | completed | Use of Individual Pharmacokinetically (PK)-Guided Sunitinib Dosing: A Feasibility Study in Patients With Advanced Solid Tumors |
| NCT02231749 results posted | CA209-214 2014-001750-42 | Ph 3 | completed | Nivolumab Combined With Ipilimumab Versus Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 214) |
| NCT03141177 CheckMate 9ER results posted | CA209-9ER 2017-000759-20 | Ph 3 | active not recruiting | A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma |
| NCT05043090 SAMETA | D5086C00001 2022-503105-38-00, 2021-000336-55 | Ph 3 | active not recruiting | Savolitinib Plus Durvalumab Versus Sunitinib and Durvalumab Monotherapy in MET-Driven, Unresectable and Locally Advanced or Metastatic PRCC |
| NCT06940349 COPS-01 | 104420-RMC | Ph 1, Ph 2 | recruiting | Interventional Study to Evaluate the Combination of Palbociclib + Sunitinib as a Treatment for Advanced Solid Tumors |
| NCT02230176 OCCLURANDOM | 2013-004032-30 2013/2043 | Ph 2 | completed | Antitumor Efficacy of Peptide Receptor Radionuclide Therapy With 177Lutetium -Octreotate Randomized vs Sunitinib in Unresectable Progressive Well-differentiated Neuroendocrine Pancreatic Tumor: First Randomized Phase II |
| NCT00720941 COMPARZ results posted | 108844 2008-002102-19, CPZP034A2301 | Ph 3 | completed | Pazopanib Versus Sunitinib in the Treatment of Locally Advanced and/or Metastatic Renal Cell Carcinoma |
| NCT01147822 results posted | 113078 CPZP034A2201, VEG113078 | Ph 2 | completed | Pazopanib Versus Sunitinib in the Treatment of Asian Subjects With Locally Advanced and/or Metastatic Renal Cell Carcinoma |
| NCT02401815 results posted | PLX121-01 | Ph 1, Ph 2 | completed | CGT9486 (Formerly Known as PLX9486) as a Single Agent and in Combination With PLX3397 (Pexidartinib) or Sunitinib in Participants With Advanced Solid Tumors |
| NCT01254864 results posted | 2010-0070 NCI-2011-00267 | Ph 2 | completed | Maximal Androgen Depletion Followed by Randomization of Maximal Androgen Ablation With Molecular Targeted Therapies |
| 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 |
| NCT00843037 SNIPP results posted | SNIPP | Ph 2 | completed | Study Of Sunitinib In Patients With Recurrent Paraganglioma/Pheochromocytoma |
| NCT04523272 | TQB2450-III-07 | Ph 3 | active not recruiting | A Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Sunitinib in Subjects With Advanced Renal Cancer |
| NCT03109015 ASSET results posted | Pro00072588 | Ph 2 | completed | Alternative Schedule Sunitinib in Metastatic Renal Cell Carcinoma: Cardiopulmonary Exercise Testing |
| NCT01306045 results posted | 110096 11-C-0096 | Ph 2 | completed | Molecular Profiling and Targeted Therapy for Advanced Non-Small Cell Lung Cancer, Small Cell Lung Cancer, and Thymic Malignancies |
Showing 50 of 183 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.
SUNITINIB MALATE FDA Label Details
Indications & Usage
SUNITINIB MALATE is indicated for the treatment of Gastrointestinal Stromal Tumor; Renal Cell Carcinoma; Pancreatic Neuroendocrine Tumor.
WARNING: HEPATOTOXICITY Hepatotoxicity may be severe, and in some cases, fatal. Monitor hepatic function and interrupt, dose reduce, or discontinue sunitinib malate capsules as recommended [see Warnings and Precautions ( 5.1 )] . WARNING: HEPATOTOXICITY See full prescribing information for complete ...
Looking for the branded version?
SUTENT
Full clinical data, patents, trials, and competitive landscape for sunitinib malate.
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