Overview
Axitinib is a second generation tyrosine kinase inhibitor that works by selectively inhibiting vascular endothelial growth factor receptors (VEGFR-1, VEGFR-2, VEGFR-3). Through this mechanism of action, axitinib blocks angiogenesis, tumour growth and metastases. It is reported to exhibit potency that is 50-450 times higher than that of the first generation VEGFR inhibitors. Axitinib is an indazole derivative. It is most commonly marketed under the name Inlyta® and is available in oral formulations.
Indication
Used in kidney cell cancer and investigated for use/treatment in pancreatic and thyroid cancer.
Associated Conditions
- Advanced Renal Cell Carcinoma
- Advanced Thyroid cancer
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/08 | Phase 2 | Not yet recruiting | |||
2025/03/21 | Phase 2 | Recruiting | |||
2025/03/06 | Phase 2 | Recruiting | |||
2024/12/10 | Phase 3 | Recruiting | Sun Yat-sen University | ||
2024/11/15 | Phase 2 | Recruiting | |||
2024/07/11 | Phase 3 | Active, not recruiting | |||
2024/04/15 | Phase 3 | Recruiting | |||
2024/02/28 | Phase 2 | Not yet recruiting | |||
2024/01/18 | Phase 2 | Recruiting | Peking University Cancer Hospital & Institute | ||
2023/12/08 | Phase 1 | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| U.S. Pharmaceuticals | 63539-026 | ORAL | 1 mg in 1 1 | 9/1/2022 | |
| Pfizer Laboratories Div Pfizer Inc | 0069-0151 | ORAL | 5 mg in 1 1 | 9/15/2022 | |
| Pfizer Laboratories Div Pfizer Inc | 0069-0145 | ORAL | 1 mg in 1 1 | 9/15/2022 | |
| U.S. Pharmaceuticals | 63539-044 | ORAL | 5 mg in 1 1 | 9/1/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 9/3/2012 | ||
Authorised | 9/19/2024 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| INLYTA TABLETS 5MG | SIN14322P | TABLET, FILM COATED | 5.000mg | 3/11/2013 | |
| INLYTA TABLETS 1MG | SIN14321P | TABLET, FILM COATED | 1.000mg | 3/11/2013 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Axitinib Tablets | 国药准字HJ20150222 | 化学药品 | 片剂 | 8/19/2024 | |
| Axitinib Tablets | 国药准字HJ20150220 | 化学药品 | 片剂 | 8/19/2024 | |
| Axitinib Tablets | 国药准字HJ20150221 | 化学药品 | 片剂 | 8/19/2024 | |
| Axitinib Tablets | 国药准字H20213406 | 化学药品 | 片剂 | 5/19/2021 | |
| Axitinib Tablets | 国药准字HJ20150219 | 化学药品 | 片剂 | 8/19/2024 | |
| Axitinib Tablets | 国药准字H20254331 | 化学药品 | 片剂 | 5/27/2025 |
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 |
|---|---|---|---|---|---|
| INLYTA axitinib 5 mg tablet bottle | 184858 | Medicine | A | 7/26/2012 | |
| INLYTA axitinib 3mg tablet blister pack | 213873 | Medicine | A | 4/30/2014 | |
| INLYTA axitinib 7mg tablet bottle | 213876 | Medicine | A | 4/30/2014 | |
| INLYTA axitinib 1 mg tablet blister pack | 184856 | Medicine | A | 7/26/2012 | |
| INLYTA axitinib 3mg tablet bottle | 213874 | Medicine | A | 4/30/2014 | |
| INLYTA axitinib 7mg tablet blister pack | 213875 | Medicine | A | 4/30/2014 | |
| INLYTA axitinib 5 mg tablet blister pack | 184859 | Medicine | A | 7/26/2012 | |
| INLYTA axitinib 1 mg tablet bottle | 184857 | Medicine | A | 7/26/2012 |
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