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
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/04/29 | N/A | AVAILABLE | |||
2025/04/23 | Phase 1 | Recruiting | |||
2024/04/30 | Phase 2 | Active, not recruiting | |||
2023/09/13 | Not Applicable | Not yet recruiting | First Affiliated Hospital, Sun Yat-Sen University | ||
2023/07/18 | Phase 4 | Not yet recruiting | |||
2023/04/18 | Not Applicable | Recruiting | |||
2023/04/05 | Phase 1 | Completed | |||
2023/02/27 | N/A | Completed | |||
2023/02/17 | Phase 3 | Recruiting | |||
2023/01/18 | Phase 1 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| U.S. Pharmaceuticals | 63539-017 | ORAL | 12.5 mg in 1 1 | 8/1/2021 | |
| Aurobindo Pharma Limited | 59651-467 | ORAL | 50 mg in 1 1 | 11/8/2023 | |
| AvKARE | 42291-904 | ORAL | 50 mg in 1 1 | 10/11/2023 | |
| U.S. Pharmaceuticals | 63539-019 | ORAL | 50 mg in 1 1 | 8/1/2021 | |
| Mylan Pharmaceuticals Inc. | 0378-6679 | ORAL | 25 mg in 1 1 | 9/7/2021 | |
| Mylan Pharmaceuticals Inc. | 0378-6678 | ORAL | 12.5 mg in 1 1 | 9/7/2021 | |
| Novadoz Pharmaceuticals LLC | 72205-117 | ORAL | 25 mg in 1 1 | 2/10/2025 | |
| Sun Pharmaceutical Industries Inc. | 63304-093 | ORAL | 37.5 mg in 1 1 | 9/30/2021 | |
| NorthStar RxLLC | 16714-678 | ORAL | 37.5 mg in 1 1 | 2/15/2022 | |
| Sun Pharmaceutical Industries Inc. | 63304-094 | ORAL | 50 mg in 1 1 | 9/30/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 7/19/2006 | ||
Authorised | 2/11/2021 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| NIBINASE HARD GELATIN CAPSULE 12.5MG | SIN16741P | CAPSULE | 12.5mg | 3/24/2023 | |
| Sutent Capsule 12.5mg | SIN13254P | CAPSULE | 12.5mg | 4/19/2007 | |
| ALSUNI CAPSULES 50MG | SIN16578P | CAPSULE | 50.0 mg | 8/24/2022 | |
| INSUNITINIB CAPSULE 25MG | SIN16270P | CAPSULE, GELATIN COATED | 25.00 mg | 7/8/2021 | |
| NIBINASE HARD GELATIN CAPSULE 25MG | SIN16742P | CAPSULE | 25mg | 3/24/2023 | |
| NIBINASE HARD GELATIN CAPSULE 50MG | SIN16743P | CAPSULE | 50mg | 3/24/2023 | |
| INSUNITINIB CAPSULE 12.5MG | SIN16269P | CAPSULE, GELATIN COATED | 12.50 mg | 7/8/2021 | |
| ALSUNI CAPSULES 12.5MG | SIN16579P | CAPSULE | 12.5 mg | 8/24/2022 | |
| INSUNITINIB CAPSULE 50MG | SIN16272P | CAPSULE, GELATIN COATED | 50.00 mg | 7/8/2021 | |
| INSUNITINIB CAPSULE 37.5MG | SIN16271P | CAPSULE, GELATIN COATED | 37.50 mg | 7/8/2021 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| SUNITINIB MSN sunitinib (as malate) 12.5 mg hard capsule bottle | 370765 | Medicine | A | 7/22/2022 | |
| SUNITINIB MSN sunitinib (as malate) 50 mg hard capsule bottle | 370767 | Medicine | A | 7/22/2022 | |
| SUNITINIB MSN sunitinib (as malate) 50 mg hard capsule blister pack | 370768 | Medicine | A | 7/22/2022 | |
| Sunitinib Sandoz sunitinib 50 mg capsule blister | 318073 | Medicine | A | 11/26/2020 | |
| Sunitinib Sandoz sunitinib 25 mg capsule blister | 318075 | Medicine | A | 11/26/2020 | |
| SUTENT sunitinib (as malate) 25 mg capsule bottle | 123146 | Medicine | A | 9/14/2006 | |
| SUTENT sunitinib (as malate) 50 mg capsule blister pack | 149116 | Medicine | A | 2/26/2008 | |
| ARX-SUNITINIB sunitinib (as malate) 25 mg capsule blister pack | 332967 | Medicine | A | 2/22/2021 | |
| Sunitinib Sandoz sunitinib 12.5 mg capsule blister | 318077 | Medicine | A | 11/26/2020 | |
| ARX-SUNITINIB sunitinib (as malate) 12.5 mg capsule blister pack | 331640 | Medicine | A | 2/22/2021 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| SANDOZ SUNITINIB | 02532840 | Capsule - Oral | 12.5 MG | 5/24/2023 | |
| SANDOZ SUNITINIB | 02532867 | Capsule - Oral | 25 MG | 5/24/2023 | |
| SANDOZ SUNITINIB | 02532875 | Capsule - Oral | 37.5 MG | N/A | |
| SANDOZ SUNITINIB | 02532883 | Capsule - Oral | 50 MG | 5/24/2023 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| SUNITINIB ACCORD 12,5 mg CAPSULAS DURAS EFG | 1201511002 | CÁPSULA DURA | Diagnóstico Hospitalario | Commercialized | |
| SUNITINIB ACCORD 37,5 mg CAPSULAS DURAS EFG | 1201511008 | CÁPSULA DURA | Diagnóstico Hospitalario | Commercialized | |
| SUNITINIB GLENMARK 12,5 MG CAPSULAS DURAS EFG | 86145 | CÁPSULA DURA | Diagnóstico Hospitalario | Not Commercialized | |
| SUNITINIB VIATRIS 12,5 MG CAPSULAS DURAS EFG | 84506 | CÁPSULA DURA | Diagnóstico Hospitalario | Commercialized | |
| SUNITINIB GLENMARK 50 MG CAPSULAS DURAS EFG | 86147 | CÁPSULA DURA | Diagnóstico Hospitalario | Not Commercialized | |
| SUNITINIB VIATRIS 50 MG CAPSULAS DURAS EFG | 84504 | CÁPSULA DURA | Diagnóstico Hospitalario | Commercialized | |
| SUNITINIB VIATRIS 25 MG CAPSULAS DURAS EFG | 84507 | CÁPSULA DURA | Diagnóstico Hospitalario | Commercialized | |
| SUTENT 25 MG CAPSULAS DURAS | 06347002 | CÁPSULA DURA | Diagnóstico Hospitalario | Commercialized | |
| SUNITINIB GLENMARK 25 MG CAPSULAS DURAS EFG | 86146 | CÁPSULA DURA | Diagnóstico Hospitalario | Not Commercialized | |
| SUNITINIB TEVA 12,5 MG CAPSULAS DURAS EFG | 83277 | CÁPSULA DURA | Diagnóstico Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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