Overview
Pazopanib is a small molecule inhibitor of multiple protein tyrosine kinases with potential antineoplastic activity. It is developed by GlaxoSmithKline and was FDA approved on October 19, 2009.
Background
Pazopanib is a small molecule inhibitor of multiple protein tyrosine kinases with potential antineoplastic activity. It is developed by GlaxoSmithKline and was FDA approved on October 19, 2009.
Indication
Treatment of advanced renal cell cancer and advanced soft tissue sarcoma (in patients previously treated with chemotherapy)
Associated Conditions
- Advanced Renal Cell Carcinoma
- Advanced Soft Tissue Sarcoma
- Advanced Thyroid cancer
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/02/10 | Phase 2 | Recruiting | Shandong Cancer Hospital and Institute | ||
2024/12/18 | Phase 2 | Recruiting | Tianjin Medical University Second Hospital | ||
2024/02/16 | Phase 3 | Recruiting | |||
2024/02/02 | Phase 1 | Recruiting | |||
2023/07/18 | Phase 4 | Not yet recruiting | |||
2023/01/11 | Phase 2 | Recruiting | |||
2022/06/27 | Phase 2 | Active, not recruiting | |||
2024/11/05 | Phase 1/2 | Recruiting | |||
2021/02/05 | Phase 3 | Recruiting | |||
2020/07/08 | Phase 2 | Completed | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| SUN PHARMACEUTICAL INDUSTRIES, INC. | 63304-116 | ORAL | 200 mg in 1 1 | 10/20/2023 | |
| Teva Pharmaceuticals, Inc. | 0480-4184 | ORAL | 200 mg in 1 1 | 4/30/2023 | |
| Novartis Pharmaceuticals Corporation | 0078-1077 | ORAL | 200 mg in 1 1 | 5/10/2023 | |
| Golden State Medical Supply, Inc. | 51407-872 | ORAL | 200 mg in 1 1 | 3/21/2024 | |
| Apotex Corp. | 60505-4779 | ORAL | 200 mg in 1 1 | 2/28/2024 | |
| Novartis Pharmaceuticals Corporation | 0078-0670 | ORAL | 200 mg in 1 1 | 5/10/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 6/14/2010 | ||
Authorised | 6/14/2010 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| TYROKA FILM-COATED TABLETS 200 MG | SIN16736P | TABLET, FILM COATED | 200mg | 3/9/2023 | |
| Votrient Tablet 200 mg | SIN14022P | TABLET, FILM COATED | 200 mg | 9/23/2011 | |
| Votrient Tablet 400 mg | SIN14023P | TABLET, FILM COATED | 400 mg | 9/23/2011 | |
| PAZOPANIB-TEVA FC TABLETS 200 MG | SIN17000P | TABLET, FILM COATED | 200 mg | 5/8/2024 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Pazopanib Tablets | 国药准字H20253053 | 化学药品 | 片剂 | 1/2/2025 | |
| Pazopanib Tablets | 国药准字H20233257 | 化学药品 | 片剂 | 3/7/2023 | |
| Pazopanib Tablets | 国药准字H20233635 | 化学药品 | 片剂 | 5/29/2023 | |
| Pazopanib Tablets | 国药准字H20233248 | 化学药品 | 片剂 | 3/7/2023 | |
| Pazopanib Tablets | 国药准字HJ20170062 | 化学药品 | 片剂 | 12/31/2021 |
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 |
|---|---|---|---|---|---|
| VOTRIENT pazopanib 200 mg tablet bottle | 161282 | Medicine | A | 6/30/2010 | |
| PAZOPANIB-RZ pazopanib (as hydrochloride) 200 mg film coated tablet bottle | 429230 | Medicine | A | 5/20/2025 | |
| PAZOPANIB DR. REDDY'S pazopanib (as hydrochloride) 400 mg film coated tablet bottle | 429233 | Medicine | A | 5/20/2025 | |
| PAZOPANIB-RZ pazopanib (as hydrochloride) 400 mg film coated tablet bottle | 429231 | Medicine | A | 5/20/2025 | |
| PAZOPANIB DR. REDDY'S pazopanib (as hydrochloride) 200 mg film coated tablet bottle | 429232 | Medicine | A | 5/20/2025 | |
| VOTRIENT pazopanib 400 mg tablet bottle | 161281 | Medicine | A | 6/30/2010 |