Overview
Ripretinib is a kinase inhibitor used for the treatment of advanced gastrointestinal stromal tumor (GIST) that has not adequately responded to other kinase inhibitors such as sunitinib and imatinib. Ripretinib, also known as Qinlock, is manufactured by Deciphera Pharmaceuticals and was initially approved by the FDA on May 15, 2020. It is the first drug approved as a fourth-line therapy in the specific setting of prior treatment with a minimum of 3 other kinase inhibitors.
Background
Ripretinib is a kinase inhibitor used for the treatment of advanced gastrointestinal stromal tumor (GIST) that has not adequately responded to other kinase inhibitors such as sunitinib and imatinib. Ripretinib, also known as Qinlock, is manufactured by Deciphera Pharmaceuticals and was initially approved by the FDA on May 15, 2020. It is the first drug approved as a fourth-line therapy in the specific setting of prior treatment with a minimum of 3 other kinase inhibitors.
Indication
Ripretinib is indicated to treat adults diagnosed with advanced gastrointestinal stromal tumor (GIST) who have had prior therapy with at least 3 kinase inhibitors, including with imatinib.
Associated Conditions
- Advanced Gastrointestinal Stromal Tumor (GIST)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/10/01 | N/A | Recruiting | |||
2023/07/24 | Phase 1 | Recruiting | |||
2023/02/17 | Phase 3 | Recruiting | |||
2023/01/25 | N/A | Active, not recruiting | Peking University | ||
2021/11/24 | Not Applicable | UNKNOWN | |||
2021/10/18 | Phase 1 | Withdrawn | |||
2020/11/18 | Phase 2 | Completed | |||
2020/08/28 | Phase 1 | Completed | |||
2020/02/25 | Phase 2 | Completed | |||
2019/11/01 | N/A | APPROVED_FOR_MARKETING |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Deciphera Pharmaceuticals, LLC | 73207-101 | ORAL | 50 mg in 1 1 | 5/15/2020 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 11/18/2021 | ||
Authorised | 11/18/2021 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| QINLOCK TABLET 50 MG | SIN16769P | TABLET | 50.0 mg | 4/28/2023 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Ripretinib Tablets | 国药准字HJ20210022 | 化学药品 | 片剂 | 3/30/2021 |
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 |
|---|---|---|---|---|---|
| QINLOCK ripretinib 50 mg tablet bottle | 327899 | Medicine | A | 7/13/2020 |