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
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/08/01 | Not Applicable | Recruiting | Patel Hospital, Pakistan | ||
2025/07/22 | Not Applicable | Not yet recruiting | |||
2025/05/30 | Phase 1 | Recruiting | Dr. Anne Conlin | ||
2025/05/21 | Phase 1 | Not yet recruiting | |||
2025/05/14 | N/A | Completed | Ankara Etlik City Hospital | ||
2025/04/09 | Phase 1 | Completed | St. Louis Joint Replacement Institute | ||
2025/03/30 | Phase 3 | Not yet recruiting | |||
2025/02/18 | Phase 4 | Not yet recruiting | |||
2025/02/11 | Phase 4 | Recruiting | |||
2025/02/04 | N/A | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Heritage Pharmaceuticals Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc. | 23155-166 | INTRAVENOUS | 1 g in 10 mL | 10/6/2022 | |
| Amneal Pharmaceuticals LLC | 70121-1398 | INTRAVENOUS | 100 mg in 1 mL | 2/27/2021 | |
| Bryant Ranch Prepack | 63629-8838 | ORAL | 650 mg in 1 1 | 1/5/2021 | |
| Gland Pharma Limited | 68083-160 | INTRAVENOUS | 100 mg in 1 mL | 6/25/2021 | |
| Bryant Ranch Prepack | 71335-1957 | ORAL | 650 mg in 1 1 | 12/18/2020 | |
| ANI Pharmaceuticals, Inc. | 62559-265 | ORAL | 650 mg in 1 1 | 6/30/2022 | |
| Eugia US LLC | 55150-188 | INTRAVENOUS | 100 mg in 1 mL | 8/2/2023 | |
| American Health Packaging | 60687-750 | ORAL | 650 mg in 1 1 | 10/1/2023 | |
| Provepharm Inc. | 81284-612 | INTRAVENOUS | 100 mg in 1 mL | 8/12/2025 | |
| Mylan Institutional LLC | 67457-197 | INTRAVENOUS | 100 mg in 1 mL | 11/16/2016 |
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 |
|---|---|---|---|---|---|
| HAEMOSTOP INJECTION 100MG/ML | SIN15052P | INJECTION, SOLUTION | 100mg/ml | 7/21/2016 | |
| CYKLOKAPRON TABLET 500 mg | SIN02487P | TABLET, FILM COATED | 500 mg | 3/9/1989 | |
| MEDSAMIC SOLUTION FOR INJECTION 100MG/ML | SIN15167P | INJECTION, SOLUTION | 100mg/ml | 1/26/2017 | |
| TAFIXYL SOLUTION FOR INJECTION 100 MG/ML | SIN16551P | INJECTION, SOLUTION | 100 mg/mL | 7/14/2022 | |
| XAMILUX INJECTION 100MG/ML | SIN15715P | INJECTION, SOLUTION | 100mg/ml | 6/12/2019 | |
| CYKLOKAPRON INJECTION 100 mg/ml | SIN02488P | INJECTION | 100 mg/ml | 3/9/1989 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| TRANSAMIN CAP 250 MG | N/A | N/A | N/A | 8/24/1978 | |
| TREN CAP 250MG | N/A | N/A | N/A | 7/4/2008 | |
| TRANSACID INJ 250MG/5ML | N/A | N/A | N/A | 11/12/1982 | |
| HAESMIN CAP 250MG | N/A | N/A | N/A | 3/1/1999 | |
| TRANSAMIN S INJ 10% | N/A | N/A | N/A | 8/24/1978 | |
| TRANSAMIN TAB 500MG | N/A | N/A | N/A | 7/21/1984 | |
| TRANSAMIN INJ 5% | N/A | N/A | N/A | 8/23/1978 |
TGA Drug Approvals
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| TRANEXAMIC ACID INJECTION | auro pharma inc | 02466015 | Solution - Intravenous | 100 MG / ML | 6/9/2021 |
| TRANEXAMIC ACID INJECTION, USP | baxter corporation | 02505274 | Solution - Intravenous | 500 MG / 5 ML | N/A |
| TRANEXAMIC ACID INJECTION | 02454785 | Solution - Intravenous | 100 MG / ML | N/A | |
| TRANEXAMIC ACID TABLETS | Sterimax Inc | 02401231 | Tablet - Oral | 500 MG | 2/13/2013 |
| TRANEXAMIC ACID INJECTION BP | Strides Pharma Canada Inc | 02455900 | Solution - Intravenous | 100 MG / ML | N/A |
| M-TRANEXAMIC ACID | mantra pharma inc | 02549395 | Tablet - Oral | 500 MG | 12/3/2024 |
| LYSTEDA | Ferring Inc | 02401959 | Tablet - Oral | 650.0 MG | N/A |
| GD-TRANEXAMIC ACID | genmed a division of pfizer canada ulc | 02409089 | Solution - Intravenous | 100 MG / ML | N/A |
| TRANEXAMIC ACID INJECTION | auro pharma inc | 02484846 | Solution - Intravenous | 100 MG / ML | N/A |
| CYKLOKAPRON 100 MG/ML | 02064413 | Solution - Intravenous | 100 MG / ML | 12/31/1995 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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