Drug

Sunitinib

Approved · EMA

ClassVascular endothelial growth factor receptor 1 inhibitorEmerging researchLate-stage developmentRising momentum

Also known as Sunitinib Malate, Sutent, Sunitinibum.

RxNorm357977 ChEMBLCHEMBL535 ATCL01EX01UNIIV99T50803M

Research papers

Active clinical trials

Protein targets

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Molecular Analysis for Therapy Choice (MATCH)

Clinical trial2026-07-31Results expected Q4 2026 · ClinicalTrials.gov

NET RETREAT: A Phase II Study of 177 Lutetium-DOTATATE Retreatment vs. Everolimus or Sunitinib or Cabozantinib in Metastatic/Unresectable Gastroenteropancreatic Neuroendocrine Tumours

Clinical trial2026-07-28Results expected Q2 2029 · ClinicalTrials.gov

Pan-Tumor Study for Long-term Treatment of Cancer Patients Who Have Participated in BMS Sponsored Trials Investigating Nivolumab and Other Cancer Therapies

Clinical trial2026-07-02Results expected Q3 2029 · ClinicalTrials.gov

A Multi-site, Open, Perspective Study of Prognostic Value and Benefit From Adjuvant Targeted Therapy of Stage III Clear Cell Renal Cell Carcinoma Based on a CpG-methylation-based Assay

Clinical trial2026-07-01Primary completion · ClinicalTrials.gov

ASSURE: Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma

Clinical trial2026-06-23Results posted · ClinicalTrials.gov

Combination Chemotherapy With or Without Maintenance Sunitinib Malate (NSC 736511) for Untreated Extensive Stage Small Cell Lung Cancer: A Phase IB/Randomized Phase II Study

Clinical trial2026-06-16Results posted · ClinicalTrials.gov

Machine-learning and mechanistic modeling of metastatic breast cancer after neoadjuvant treatment.

Research2024-05-03PLoS computational biology

Genomic profiling in GIST: Implications in clinical outcome and future challenges.

Research2024-01-05Neoplasia (New York, N.Y.)

Nivolumab plus Cabozantinib versus Sunitinib for Advanced Renal-Cell Carcinoma.

Research2021-03-01The New England journal of medicine

Approval: Sunitinib Accord (EMA)

Regulatory2021-02-11EMA

Liver transarterial chemoembolization and sunitinib for unresectable hepatocellular carcinoma: Results of the PRODIGE 16 study.

Research2020-06-21Clinics and research in hepatology and gastroenterology

Approval: Sutent (EMA)

Regulatory2006-07-19EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Sunitinib

Aliases & brands

Sunitinib MalateSutentSunitinibum

RxNorm CUI

357977

ChEMBL ID

CHEMBL535

ATC codes

L01EX01

UNII

V99T50803M

Primary mechanism

Vascular endothelial growth factor receptor 1 inhibitor

Regulatory jurisdictions

ema

Pharmacology & targets

9 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Vascular endothelial growth factor receptor 1

FLT1 · P17948

INHIBITORVascular endothelial growth factor receptor 1 inhibitor

Vascular endothelial growth factor receptor 3

FLT4 · P35916

INHIBITORVascular endothelial growth factor receptor 3 inhibitor

Vascular endothelial growth factor receptor 2

KDR · P35968

INHIBITORVascular endothelial growth factor receptor 2 inhibitor

Macrophage colony-stimulating factor 1 receptor

CSF1R · P07333

INHIBITORMacrophage colony stimulating factor receptor inhibitor

Receptor-type tyrosine-protein kinase FLT3

FLT3 · P36888

INHIBITORTyrosine-protein kinase receptor FLT3 inhibitor

Mast/stem cell growth factor receptor Kit

KIT · P10721

INHIBITORStem cell growth factor receptor inhibitor

Platelet-derived growth factor receptor beta

PDGFRB · P09619

INHIBITORPlatelet-derived growth factor receptor beta inhibitor

Platelet-derived growth factor receptor alpha

PDGFRA · P16234

INHIBITORPlatelet-derived growth factor receptor alpha inhibitor

Proto-oncogene tyrosine-protein kinase receptor Ret

RET · P07949

INHIBITORTyrosine-protein kinase receptor RET inhibitor

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2006-07-19

Latest approval

2021-02-11

Authorities

EMA

Total events

emaEuropean Medicines Agency· 2 events

2021-02-11Approval

Approval: Sunitinib Accord (EMA)

Indication: Gastrointestinal stromal tumour (GIST) Sunitinib Accord is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) in adults… Show full indication

Gastrointestinal stromal tumour (GIST) Sunitinib Accord is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) in adults after failure of imatinib treatment due to resistance or intolerance. Metastatic renal cell carcinoma (MRCC) Sunitinib Accord is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults. Pancreatic neuroendocrine tumours (pNET) Sunitinib Accord is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pNET) with disease progression in adults.

Evidence ↗

2006-07-19Approval

Approval: Sutent (EMA)

Indication: Gastrointestinal stromal tumour (GIST) Sutent is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) in adults after… Show full indication

Gastrointestinal stromal tumour (GIST) Sutent is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) in adults after failure of imatinib mesilate treatment due to resistance or intolerance. Metastatic renal cell carcinoma (MRCC) Sutent is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults. Pancreatic neuroendocrine tumours (pNET) Sutent is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours with disease progression in adults. Experience with Sutent as first-line treatment is limited (see section 5.1).

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

194 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

194

registered trials across all phases

LATEST COMPLETION 2025

Active studies

Recruiting

Late-stage (III+)

113

Completed

Discontinued

PHASE DISTRIBUTIONn = 194

Early Phase 11Phase 134Phase 1 / 28Phase 2113Phase 2 / 31Phase 323Phase 43Phase N / A11

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Therapeutic Drug Monitoring of Sunitinib and Pazopanib in Advanced or Metastatic Renal Cell Carcinoma

CompletedPH IVInstitut Claudius Regaudn=472020

Study to Evaluate the Safety and Efficacy of Sunitinib, in Subject With Refractory Solid Tumors

CompletedPH IVSamsung Medical Centern=12019

A Study of Biological, Pathological and Imagery Markers in the First-line Treatment of Metastatic Clear-cell Renal Cell Carcinoma With Sunitinib BEFORE and AFTER Nephrectomy

TerminatedPH IVAssistance Publique - Hôpitaux de Parisn=332013

Phase 1b/3 Global, Randomized, Controlled, Open-label Trial Comparing Treatment With RYZ101 to Standard of Care Therapy in Subjects With Inoperable, Advanced, SSTR+, Well-differentiated GEP-NETs That Have Progressed Following Prior 177Lu-SSA Therapy

RecruitingPH IIIRayzeBio, Inc.n=3382030

A Phase 3, Randomized, Multicenter, Open-Label Study of IDRX-42 (GSK6042981) Versus Sunitinib in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST) After Imatinib Therapy (StrateGIST 3)

RecruitingPH IIIGlaxoSmithKlinen=4502030

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 3, Randomized, Open-Label Study of Nivolumab Combined With Ipilimumab Versus Sunitinib Monotherapy in Subjects With Previously Untreated, Advanced or Metastatic Renal Cell Carcinoma

CompletedPH IIIKey trialBristol-Myers Squibbn=1,0962025

A Phase II Study of Sunitinib in Patients With Advanced Relapsed or Refractory Thymoma or Thymic Carcinoma With at Least One Prior Line of Platinum-Based Systemic Chemotherapy

CompletedPH IINational Cancer Institute (NCI)n=562024

A PHASE 3, MULTINATIONAL, RANDOMIZED, OPEN-LABEL, PARALLEL-ARM STUDY OF AVELUMAB (MSB0010718C) IN COMBINATION WITH AXITINIB (INLYTA(REGISTERED)) VERSUS SUNITINIB (SUTENT(REGISTERED)) MONOTHERAPY IN THE FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED RENAL CELL CARCINOMA

CompletedPH IIIPfizern=8862024

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.

CompletedPH IIGustave Roussy, Cancer Campus, Grand Parisn=842024

Autophagic Modulation With Anti-angiogenic Therapy in Patients With Advanced Malignancies: A Phase I Trial of Sunitinib and Hydroxychloroquine

CompletedPH INational Cancer Institute (NCI)n=402023

A Phase 2, Randomized, Multicenter, Open-label Study of DCC-2618 (Ripretinib, ZL-2307 ) vs Sunitinib in Patients With Advanced Gastrointestinal Stromal Tumors After Treatment With Imatinib

CompletedPH IIZai Lab (Shanghai) Co., Ltd.n=1082022

Research activity

21 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time

20062024

Most influential

Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell Carcinoma.

The New England journal of medicine · 2018 · 3,404 cites

Pembrolizumab plus Axitinib versus Sunitinib for Advanced Renal-Cell Carcinoma.

The New England journal of medicine · 2019 · 2,427 cites

Pazopanib versus sunitinib in metastatic renal-cell carcinoma.

The New England journal of medicine · 2013 · 1,353 cites

Nivolumab plus Cabozantinib versus Sunitinib for Advanced Renal-Cell Carcinoma.

The New England journal of medicine · 2021 · 1,297 cites

Activity of SU11248, a multitargeted inhibitor of vascular endothelial growth factor receptor and platelet-derived growth factor receptor, in patients with metastatic renal cell carcinoma.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2006 · 1,110 cites

Safety, pharmacokinetic, and antitumor activity of SU11248, a novel oral multitarget tyrosine kinase inhibitor, in patients with cancer.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2006 · 832 cites

Related diseases

4 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Approved indications

Carcinoma, Renal Cell7

Active research areas

Kidney Neoplasms7 Hypertension2 Neoplasm Metastasis2

Related drugs

7 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Axitinib

Acts on the same molecular target as Sunitinib, with 3 overlapping disease areas.

3 shared targets3 shared diseases3 shared papers

Imatinib Mesylate

Acts on the same molecular target as Sunitinib, with 3 overlapping disease areas.

2 shared targets3 shared diseases1 shared paper

Pembrolizumab

Studied across 5 of the same disease areas as Sunitinib in the shared literature.

5 shared diseases1 shared paper

Avelumab

Studied across 4 of the same disease areas as Sunitinib in the shared literature.

4 shared diseases1 shared paper

Cabozantinib

Studied across 4 of the same disease areas as Sunitinib in the shared literature.

4 shared diseases1 shared paper

Pazopanib

Studied across 2 of the same disease areas as Sunitinib in the shared literature.

2 shared diseases1 shared paper

Sorafenib

Studied across the same disease area as Sunitinib in the shared literature.

1 shared disease1 shared paper

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
Europe PMC — research literature
ClinicalTrials.gov — clinical trials
Regulatory event sources are credited in the Regulatory Timeline above.