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.
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 |
|---|---|---|---|---|---|
2025/02/04 | N/A | Recruiting | |||
2025/01/08 | Not Applicable | Not yet recruiting | |||
2024/12/31 | Phase 4 | Recruiting | |||
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2024/10/16 | Phase 2 | Withdrawn | |||
2024/10/11 | Phase 3 | Withdrawn | |||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 |
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 | |
| Dr. Reddy's Laboratories Inc. | 75907-309 | ORAL | 650 mg in 1 1 | 8/1/2025 | |
| 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 |
EMA Drug Approvals
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|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Health Canada Drug Approvals
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Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| MAR-TRANEXAMIC ACID | marcan pharmaceuticals inc | 02496232 | Tablet - Oral | 500 MG | 6/4/2020 |
| TRANEXAMIC ACID INJECTION | eugia pharma inc. | 02531208 | Solution - Intravenous | 100 MG / ML | 11/6/2024 |
| ERFA-TRANEXAMIC | searchlight pharma inc | 02457431 | Solution - Intravenous | 100 MG / ML | 7/31/2017 |
| TRANEXAMIC ACID INJECTION | eugia pharma inc. | 02531216 | Solution - Intravenous | 100 MG / ML | N/A |
| CYKLOKAPRON 500 MG | 02064405 | Tablet - Oral | 500 MG | 12/31/1995 | |
| GD-TRANEXAMIC ACID | genmed a division of pfizer canada ulc | 02409097 | Tablet - Oral | 500 MG | 3/7/2014 |
| TRANEXAMIC ACID | 02519194 | Tablet - Oral | 500 MG | 2/23/2022 | |
| TRANEXAMIC ACID INJECTION BP | 02246365 | Solution - Intravenous | 100 MG / ML | 10/29/2002 | |
| TRANEXAMIC ACID INJECTION, USP | baxter corporation | 02505282 | Solution - Intravenous | 1000 MG / 10 ML | N/A |
| TRANEXAMIC ACID INJECTION | 02497328 | Solution - Intravenous | 100 MG / ML | 4/30/2021 |
CIMA AEMPS Drug Approvals
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| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
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| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
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Malaysia NPRA Drug Approvals
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UK EMC Drug Information
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Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
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| No UK EMC drug information found for this drug. | |||||
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