Overview
Tranexamic acid is a synthetic derivative of lysine used as an antifibrinolytic in the treatment and prevention of major bleeding. It possesses a similar mechanism of action to aminocaproic acid but is approximately 10-fold more potent. It was first patented in 1957 and received its initial US approval in 1986.
Background
Tranexamic acid is a synthetic derivative of lysine used as an antifibrinolytic in the treatment and prevention of major bleeding. It possesses a similar mechanism of action to aminocaproic acid but is approximately 10-fold more potent. It was first patented in 1957 and received its initial US approval in 1986.
Indication
Taken orally, tranexamic acid is indicated for the treatment of hereditary angioedema, cyclic heavy menstrual bleeding in premenopausal females, and other instances of significant bleeding in the context of hyperfibrinolysis. Given intravenously, tranexamic acid is indicated for short-term use (2-8 days) in patients with hemophilia to prevent or reduce bleeding following tooth extraction.
Associated Conditions
- Bleeding
- Heavy Menstrual Bleeding
- Hereditary Angioedema (HAE)
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/06/23 | Not Applicable | Completed | Sanliurfa Mehmet Akif Inan Education and Research Hospital | ||
2022/06/22 | Early Phase 1 | Recruiting | Shaukat Khanum Memorial Cancer Hospital & Research Centre | ||
2022/05/12 | Phase 2 | Recruiting | |||
2022/05/05 | Phase 1 | Completed | Combined Military Hospital Abbottabad | ||
2022/05/03 | N/A | Completed | Haseki Training and Research Hospital | ||
2022/05/02 | Early Phase 1 | Completed | |||
2022/04/26 | Phase 4 | Recruiting | |||
2022/04/22 | Phase 4 | Completed | |||
2022/04/13 | Phase 4 | Completed | |||
2022/04/12 | Phase 3 | Recruiting |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Tranexamic Acid Injection | 国药准字H20243390 | 化学药品 | 注射剂 | 3/29/2024 | |
| Tranexamic Acid Injection | 国药准字H20223839 | 化学药品 | 注射剂 | 6/9/2023 | |
| Tranexamic Acid Injection | 国药准字H20223969 | 化学药品 | 注射剂 | 12/30/2022 | |
| Tranexamic Acid Injection | 国药准字H37021992 | 化学药品 | 注射剂 | 3/25/2020 | |
| Tranexamic Acid Injection | 国药准字H20056277 | 化学药品 | 注射剂 | 3/25/2022 | |
| Tranexamic Acid Injection | 国药准字H41021568 | 化学药品 | 注射剂 | 9/4/2020 | |
| Tranexamic Acid Injection | 国药准字H20057475 | 化学药品 | 注射剂 | 9/10/2020 | |
| Tranexamic Acid Injection | 国药准字H20123006 | 化学药品 | 注射剂 | 7/5/2021 | |
| Tranexamic Acid Injection | 国药准字H21020644 | 化学药品 | 注射剂 | 6/19/2020 | |
| Tranexamic Acid Injection | 国药准字H31021856 | 化学药品 | 注射剂 | 4/15/2020 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||