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 |
---|---|---|---|---|---|
2025/05/30 | 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 | Not yet recruiting | |||
2025/02/04 | N/A | Recruiting | |||
2025/01/08 | Not Applicable | Not yet recruiting | |||
2024/12/31 | Phase 4 | 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 | 8/24/2021 | |
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 |
---|---|---|---|---|---|
Tranexamic Acid for Injection | 国药准字H20040695 | 化学药品 | 注射剂(冻干粉针剂 ) | 3/20/2020 | |
Tranexamic Acid for Injection | 国药准字H20031170 | 化学药品 | 注射剂(冻干) | 4/9/2020 | |
Tranexamic Acid for Injection | 国药准字H20060098 | 化学药品 | 注射剂(冻干) | 4/9/2020 | |
Tranexamic Acid for Injection | 国药准字H20040696 | 化学药品 | 注射剂(冻干粉针剂 ) | 3/20/2020 | |
Tranexamic Acid for Injection | 国药准字H20031171 | 化学药品 | 注射剂(冻干) | 4/9/2020 | |
Tranexamic Acid for Injection | 国药准字H20031172 | 化学药品 | 注射剂 | 4/1/2020 | |
Tranexamic Acid for Injection | 国药准字H20030587 | 化学药品 | 注射剂(冻干) | 9/13/2020 | |
Tranexamic Acid Injection | 国药准字H41025296 | 化学药品 | 注射剂 | 8/31/2020 | |
Tranexamic Acid Injection | 国药准字H20258023 | 化学药品 | 注射剂 | 3/5/2025 | |
Tranexamic Acid Injection | 国药准字H20244339 | 化学药品 | 注射剂 | 6/28/2024 |
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
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