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 |
|---|---|---|---|---|---|
2024/12/10 | Early Phase 1 | Recruiting | |||
2024/11/27 | Phase 2 | Completed | District Headquarters Teaching Hospital Sahiwal | ||
2024/10/26 | Phase 2 | Recruiting | Kristen Ban | ||
2024/10/16 | Phase 2 | Withdrawn | |||
2024/10/11 | Phase 3 | Withdrawn | |||
2024/10/01 | Phase 3 | ENROLLING_BY_INVITATION | |||
2024/09/19 | Not Applicable | Recruiting | |||
2024/09/19 | Not Applicable | Recruiting | |||
2024/09/09 | Not Applicable | Completed | |||
2024/07/26 | Not Applicable | Recruiting |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Heritage Pharmaceuticals Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc. | 23155-524 | INTRAVENOUS | 1 g in 10 mL | 10/4/2022 | |
| Aurobindo Pharma Limited | 59651-839 | ORAL | 650 mg in 1 1 | 12/7/2023 | |
| American Regent, Inc. | 0517-0960 | INTRAVENOUS | 100 mg in 1 mL | 3/1/2021 | |
| A-S Medication Solutions | 50090-5072 | INTRAVENOUS | 100 mg in 1 mL | 9/11/2020 | |
| Zydus Lifesciences Limited | 70771-1085 | INTRAVENOUS | 100 mg in 1 mL | 11/5/2022 | |
| Almaject, Inc. | 72611-760 | INTRAVENOUS | 100 mg in 1 mL | 6/25/2021 | |
| Actavis Pharma, Inc. | 0591-3720 | ORAL | 650 mg in 1 1 | 1/5/2021 | |
| Apotex Corp. | 60505-6169 | INTRAVENOUS | 100 mg in 1 mL | 12/5/2023 | |
| Amring Pharmaceuticals, Inc. | 69918-301 | ORAL | 650 mg in 1 1 | 12/18/2020 | |
| Armas Pharmaceuticals Inc. | 72485-107 | INTRAVENOUS | 100 mg in 1 mL | 12/21/2021 |
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H33021099 | 化学药品 | 注射剂 | 6/12/2020 | |
| Tranexamic Acid Injection | 国药准字H23020969 | 化学药品 | 注射剂 | 10/20/2020 | |
| Tranexamic Acid Injection | 国药准字H20233661 | 化学药品 | 注射剂 | 6/7/2023 | |
| Tranexamic Acid Injection | 国药准字H20234559 | 化学药品 | 注射剂 | 11/28/2023 | |
| Tranexamic Acid Injection | 国药准字H20223765 | 化学药品 | 注射剂 | 10/25/2022 | |
| Tranexamic Acid Injection | 国药准字H20223389 | 化学药品 | 注射剂 | 6/16/2022 | |
| Tranexamic Acid Injection | 国药准字H20057547 | 化学药品 | 注射剂 | 6/10/2020 | |
| Tranexamic Acid Injection | 国药准字H20227070 | 化学药品 | 注射剂 | 12/28/2023 | |
| Tranexamic Acid Injection | 国药准字H14020888 | 化学药品 | 注射剂 | 8/25/2020 | |
| Tranexamic Acid Injection | 国药准字H20223955 | 化学药品 | 注射剂 | 12/30/2022 |
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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