Overview
Raltitrexed (brand name Tomudex®) is a chemotherapy drug manufactured AstraZeneca Company, is an antimetabolite used in chemotherapy. It is an inhibitor of thymidylate synthase.
Background
Raltitrexed (brand name Tomudex®) is a chemotherapy drug manufactured AstraZeneca Company, is an antimetabolite used in chemotherapy. It is an inhibitor of thymidylate synthase.
Indication
For the treatment of malignant neoplasm of colon and rectum
Associated Conditions
- Advanced Colorectal Cancer
- Pleural Mesotheliomas
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/10/22 | Phase 2 | Not yet recruiting | |||
2024/05/23 | Phase 2 | Recruiting | |||
2023/03/13 | Phase 3 | Recruiting | Zhujiang Hospital | ||
2023/01/27 | Phase 3 | Recruiting | Zhujiang Hospital | ||
2022/11/28 | Phase 2 | Recruiting | |||
2022/06/28 | Phase 2 | Active, not recruiting | |||
2022/06/22 | Phase 1 | Not yet recruiting | |||
2021/12/16 | Phase 2 | Recruiting | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||
2021/12/08 | Phase 2 | UNKNOWN | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||
2021/02/18 | Phase 1 | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Raltitrexed for Injection | 国药准字H20090325 | 化学药品 | 注射剂 | 7/29/2019 | |
| Raltitrexed for Injection | 国药准字H20213097 | 化学药品 | 注射剂 | 2/2/2021 | |
| Raltitrexed for Injection | 国药准字H20223017 | 化学药品 | 注射剂 | 1/18/2022 | |
| Raltitrexed for Injection | 国药准字H20244205 | 化学药品 | 注射剂 | 6/28/2024 |
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 |
|---|---|---|---|---|---|
| TOMUDEX raltitrexed 2mg powder for injection vial | 54638 | Medicine | A | 7/15/1996 | |
| Hospira Tomudex powder for solution for infusion 2 mg/vial | 194724 | Medicine | A | 2/20/2012 |