Overview
Regorafenib is an orally-administered inhibitor of multiple kinases. It is used for the treatment of metastatic colorectal cancer, advanced gastrointestinal stromal tumours, and hepatocellular carcinoma. FDA approved on September 27, 2012. Approved use of Regorafenib was expanded to treat Hepatocellular Carcinoma in April 2017.
Background
Regorafenib is an orally-administered inhibitor of multiple kinases. It is used for the treatment of metastatic colorectal cancer, advanced gastrointestinal stromal tumours, and hepatocellular carcinoma. FDA approved on September 27, 2012. Approved use of Regorafenib was expanded to treat Hepatocellular Carcinoma in April 2017.
Indication
Regorafenib is indicated for the treatment of patients with metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy. Regorafenib is also indicated for the treatment of patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumour (GIST) who have been previously treated with imatinib mesylate and sunitinib malate. Regorafenib is also indicated for the treatment of patients with hepatocellular carcinoma (HCC) previously treated with sorafenib.
Associated Conditions
- Hepatocellular Carcinoma
- Metastatic Colorectal Cancer (CRC)
- Metastatic Gastrointestinal Stromal Tumor (GIST)
- Locally advanced Gastrointestinal stromal tumor
- Unresectable Gastrointestinal stromal tumor
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/04/29 | Phase 2 | Recruiting | Sergey Orlov, MD | ||
2025/03/30 | Phase 2 | Not yet recruiting | |||
2025/03/20 | Phase 2 | Recruiting | |||
2025/02/17 | Phase 2 | Recruiting | |||
2025/02/11 | Phase 2 | Not yet recruiting | |||
2024/11/11 | Phase 1 | Not yet recruiting | Shanghai Runshi Pharmaceutical Technology Co., Ltd | ||
2024/08/28 | Phase 2 | Withdrawn | City of Hope Medical Center | ||
2024/06/13 | Not Applicable | Recruiting | |||
2024/06/12 | Phase 1 | Suspended | City of Hope Medical Center | ||
2024/06/12 | Phase 2 | Recruiting | Jin-hong Chen |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Bayer HealthCare Pharmaceuticals Inc. | 50419-171 | ORAL | 40 mg in 1 1 | 12/9/2020 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 8/26/2013 | ||
Authorised | 8/26/2013 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Stivarga Tablet 40mg | SIN14360P | TABLET, FILM COATED | 40.00mg | 6/7/2013 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Regorafenib Tablets | 国药准字H20244635 | 化学药品 | 片剂 | 8/5/2024 | |
| Regorafenib Tablets | 国药准字H20253676 | 化学药品 | 片剂 | 3/25/2025 | |
| Regorafenib Tablets | 国药准字H20253178 | 化学药品 | 片剂 | 1/14/2025 | |
| Regorafenib Tablets | 国药准字H20243057 | 化学药品 | 片剂 | 1/16/2024 | |
| Regorafenib Tablets | m/s aizant drug research solutions private limited | 国药准字HJ20250012 | 化学药品 | 片剂 | 1/24/2025 |
| Regorafenib Tablets | 国药准字HJ20171300 | 化学药品 | 片剂 | 7/29/2021 | |
| Regorafenib Tablets | 国药准字H20243496 | 化学药品 | 片剂 | 4/17/2024 | |
| Regorafenib Tablets | 国药准字H20233172 | 化学药品 | 片剂 | 2/14/2023 | |
| Regorafenib Tablets | 国药准字H20243059 | 化学药品 | 片剂 | 1/16/2024 | |
| Regorafenib Tablets | 国药准字H20243570 | 化学药品 | 片剂 | 7/23/2024 |
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 |
|---|---|---|---|---|---|
| STIVARGA regorafenib 40 mg tablet bottle | 200553 | Medicine | A | 11/29/2013 |