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.
Background
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 | ||
Accord Healthcare S.L.U.,Edificio Este Planta 6a,World Trade Center,Moll De Barcelona S/n,08039 Barcelona,SPAIN | Authorised | 2/11/2021 | |
Authorised | 2/11/2021 | ||
Authorised | 2/11/2021 | ||
Authorised | 7/19/2006 | ||
Accord Healthcare S.L.U.,Edificio Este Planta 6a,World Trade Center,Moll De Barcelona S/n,08039 Barcelona,SPAIN | Authorised | 2/11/2021 | |
Authorised | 2/11/2021 | ||
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 |
|---|---|---|---|---|---|
| Sunitinib Malate Capsules | 国药准字HJ20171144 | 化学药品 | 胶囊剂 | 7/29/2022 | |
| Sunitinib Malate Capsules | 国药准字H20213192 | 化学药品 | 胶囊剂 | 3/23/2021 | |
| Sunitinib Malate Capsules | 国药准字H20213753 | 化学药品 | 胶囊剂 | 9/30/2021 | |
| Sunitinib Malate Capsules | 国药准字H20234099 | 化学药品 | 胶囊剂 | 9/5/2023 | |
| Sunitinib Malate Capsules | 国药准字HJ20171139 | 化学药品 | 胶囊剂 | 7/29/2022 | |
| Sunitinib Malate Capsules | 国药准字HJ20171143 | 化学药品 | 胶囊剂 | 7/29/2022 | |
| Sunitinib Malate Capsules | 国药准字HJ20171137 | 化学药品 | 胶囊剂 | 7/29/2022 | |
| Sunitinib Malate Capsules | 国药准字H20213754 | 化学药品 | 胶囊剂 | 9/30/2021 | |
| Sunitinib Malate Capsules | 国药准字HJ20171142 | 化学药品 | 胶囊剂 | 7/29/2022 | |
| Sunitinib Malate Capsules | 国药准字H20213756 | 化学药品 | 胶囊剂 | 9/30/2021 |
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 |