Overview
Sunitinib is a small-molecule multi-targeted receptor tyrosine kinase (RTK) inhibitor. On January 26, 2006, the agent was formally approved by the US FDA for the indications of treating renal cell carcinoma (RCC) and imatinib-resistant gastrointestinal stromal tumor (GIST). For these purposes, sunitinib is generally available as an orally administered formulation. Sunitinib inhibits cellular signaling by targeting multiple RTKs. These include all platelet-derived growth factor receptors (PDGF-R) and vascular endothelial growth factor receptors (VEGF-R). Sunitinib also inhibits KIT (CD117), the RTK that drives the majority of GISTs. In addition, sunitinib inhibits other RTKs including RET, CSF-1R, and flt3.
Indication
Sunitinib is indicated for the following conditions:
Associated Conditions
- Gastrointestinal Stromal Tumor (GIST)
 - Renal Cell Carcinoma (RCC)
 - Renal Cell Carcinoma Recurrent
 - Unresectable, locally advanced Progressive Neuroendocrine Tumors of pancreatic origin
 - Unresectable, metastatic Progressive Neuroendocrine Tumors of pancreatic origin
 
Clinical Trials
View More Clinical Trials
Sign in to access the complete clinical trial database with detailed study information.
Title  | Posted  | Study ID  | Phase  | Status  | Sponsor  | 
|---|---|---|---|---|---|
2008/06/18  | N/A  | Completed  | |||
2008/06/18  | Phase 3  | Terminated  | |||
2008/06/17  | Phase 2  | Completed  | |||
2008/06/11  | Phase 2  | Completed  | |||
2008/06/10  | Phase 1  | Completed  | |||
2008/06/09  | Phase 3  | Completed  | |||
2008/05/26  | N/A  | Completed  | |||
2008/05/15  | Phase 2  | Completed  | Argos Therapeutics  | ||
2008/05/13  | Phase 3  | Terminated  | |||
2008/05/07  | Phase 1  | Terminated  | 
FDA Drug Approvals
View More FDA Approvals
Sign in to access additional FDA-approved drug information with detailed regulatory data.
Approved Product  | Manufacturer  | NDC Code  | Route  | Strength  | Effective Date  | 
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
View More EMA Approvals
Sign in to access additional EMA-approved drug information with detailed regulatory data.
Approved Product  | Authorization Holder  | Status  | Issued Date  | 
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
View More HSA Approvals
Sign in to access additional HSA-approved drug information with detailed regulatory data.
Approved Product  | Manufacturer  | Approval Number  | Dosage Form  | Strength  | Approval Date  | 
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
View More NMPA Approvals
Sign in to access additional NMPA-approved drug information with detailed regulatory data.
Approved Product  | Company  | Approval Number  | Drug Type  | Dosage Form  | Approval Date  | 
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
View More PPB Approvals
Sign in to access additional PPB-approved drug information with detailed regulatory data.
Approved Product  | Registration No.  | Company  | Licence No.  | Strength  | Registration Date  | 
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
View More TGA Approvals
Sign in to access additional TGA-approved drug information with detailed regulatory data.
Approved Product  | ARTG ID  | Sponsor  | Registration Type  | Status  | Registration Date  | 
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
View More Health Canada Approvals
Sign in to access additional Health Canada approved drug information with detailed regulatory data.
Approved Product  | Company  | DIN  | Dosage Form  | Strength  | Market Date  | 
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
View More CIMA AEMPS Approvals
Sign in to access additional CIMA AEMPS approved drug information with detailed regulatory data.
Approved Product  | Company  | Registration Number  | Pharmaceutical Form  | Prescription Type  | Status  | 
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
View More Philippines FDA Approvals
Sign in to access additional Philippines FDA approved drug information with detailed regulatory data.
Approved Product  | Company  | License Number  | Dosage Form  | Strength  | Approval Date  | 
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
View More Saudi SFDA Approvals
Sign in to access additional Saudi SFDA approved drug information with detailed regulatory data.
Approved Product  | Company  | License Number  | Dosage Form  | Strength  | Approval Date  | 
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
View More Malaysia NPRA Approvals
Sign in to access additional Malaysia NPRA approved drug information with detailed regulatory data.
Approved Product  | Company  | Registration Number  | Dosage Form  | Strength  | Approval Date  | 
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
View More UK EMC Drug Information
Sign in to access additional UK EMC drug information with detailed pharmaceutical data.
Medicine Name  | MA Holder  | MA Number  | Pharmaceutical Form  | Active Ingredient  | Authorization Date  | 
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.
