Overview
Sorafenib is a bi-aryl urea and an oral multikinase inhibitor. It targets cell surface tyrosine kinase receptors and downstream intracellular kinases that are implicated in tumour cell proliferation and tumour angiogenesis. First approved by the FDA and European Commission in 2007 for the treatment of hepatocellular carcinoma, sorafenib is also indicated to treat renal carcinoma and differentiated thyroid carcinoma.
Indication
Sorafenib is indicated for the treatment of unresectable hepatocellular carcinoma and advanced renal cell carcinoma. In the US, it is also indicated for the treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma that is refractory to radioactive iodine treatment.
Associated Conditions
- Advanced Renal Cell Carcinoma
- Angiosarcoma
- Gastrointestinal Stromal Tumor (GIST)
- Leiomyosarcoma (LMS)
- Unresectable Hepatocellular Carcinoma (HCC)
- Progressive, locally recurrent radioactive iodine-refractory Differentiated Thyroid Carcinoma (DTC)
- Progressive, metastatic radioactive iodine-refractory Differentiated Thyroid Carcinoma (DTC)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/01/28 | Early Phase 1 | Completed | Disruptive Pharma | ||
2025/01/09 | Phase 1 | Recruiting | |||
2024/11/15 | Phase 2 | Recruiting | |||
2024/08/01 | Phase 2 | Recruiting | St. Petersburg State Pavlov Medical University | ||
2024/07/30 | Phase 1 | Recruiting | |||
2024/07/01 | Phase 2 | Recruiting | |||
2024/06/26 | Phase 1 | Not yet recruiting | |||
2024/03/13 | Phase 2 | Not yet recruiting | Zhejiang Haichang Biotech Co., Ltd. | ||
2024/01/26 | Phase 2 | Not yet recruiting | Second Xiangya Hospital of Central South University | ||
2024/01/24 | Phase 2 | Recruiting | Children's Hospital of Soochow University |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Golden State Medical Supply, Inc. | 51407-760 | ORAL | 200 mg in 1 1 | 12/19/2023 | |
| TWi Pharmaceuticals USA, Inc. | 24979-715 | ORAL | 200 mg in 1 1 | 10/23/2023 | |
| Teva Pharmaceuticals, Inc. | 0480-5425 | ORAL | 200 mg in 1 1 | 7/1/2022 | |
| Bayer HealthCare Pharmaceuticals Inc. | 50419-489 | ORAL | 200 mg in 1 1 | 8/28/2023 | |
| Mylan Pharmaceuticals Inc. | 0378-1201 | ORAL | 200 mg in 1 1 | 11/15/2021 | |
| Dr.Reddys Laboratories Inc | 43598-458 | ORAL | 200 mg in 1 1 | 11/18/2022 | |
| Bayer HealthCare Pharmaceuticals Inc. | 50419-488 | ORAL | 200 mg in 1 1 | 8/28/2023 | |
| Torrent Pharmaceuticals Limited | 13668-682 | ORAL | 200 mg in 1 1 | 4/20/2023 | |
| Yabao Pharmaceutical Co., Ltd. Beijing | 51990-201 | ORAL | 200 mg in 1 1 | 2/17/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 11/9/2022 | ||
Authorised | 7/19/2006 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| NEXAVAR TABLET 200 mg | SIN13339P | TABLET, FILM COATED | 200 mg | 8/24/2007 | |
| INFENIB FILM COATED TABLET 200MG | SIN16485P | TABLET, FILM COATED | 200.00 mg | 5/6/2022 | |
| SORAFENIB ALVOGEN FILM COATED TABLETS 200MG | SIN16442P | TABLET, FILM COATED | 200.00 mg | 3/9/2022 | |
| SORAVAR 200 FILM COATED TABLET 200 MG | SIN16774P | TABLET, FILM COATED | 200 mg | 5/10/2023 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Sorafenib Tosylate Tablets | 国药准字H20203397 | 化学药品 | 片剂 | 8/5/2020 | |
| Sorafenib Tosylate Tablets | 国药准字H20234069 | 化学药品 | 片剂 | 8/29/2023 | |
| Sorafenib Tosylate Tablets | 国药准字HJ20160201 | 化学药品 | 片剂 | 10/16/2020 | |
| Sorafenib Tosylate Tablets | 国药准字H20223848 | 化学药品 | 片剂 | 11/15/2022 | |
| Sorafenib Tosylate Tablets | 国药准字H20234644 | 化学药品 | 片剂 | 12/13/2023 | |
| Sorafenib Tosylate Tablets | 国药准字H20213293 | 化学药品 | 片剂 | 4/20/2021 | |
| Sorafenib Tosylate Tablets | 国药准字H20213311 | 化学药品 | 片剂 | 4/27/2021 | |
| Sorafenib Tosylate Tablets | 国药准字H20203403 | 化学药品 | 片剂 | 8/12/2020 |
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 |
|---|---|---|---|---|---|
| NEXAVAR sorafenib 200 mg (as tosilate) tablet blister pack | 123158 | Medicine | A | 9/27/2006 |
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