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
View More Clinical Trials
Sign in to access the complete clinical trial database with detailed study information.
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/04/11 | Not Applicable | Completed | |||
2022/04/04 | Phase 4 | Completed | Luxurgery | ||
2025/01/07 | Phase 3 | Not yet recruiting | Aquitaine Sante | ||
2022/02/21 | Not Applicable | Completed | |||
2022/02/11 | Not Applicable | Completed | |||
2022/01/24 | Not Applicable | Completed | |||
2021/10/29 | Phase 4 | Active, not recruiting | |||
2021/10/18 | Phase 4 | Completed | |||
2021/10/12 | Phase 2 | Active, not recruiting | |||
2021/09/27 | Phase 2 | Completed | Newsoara Biopharma Co., Ltd. |
FDA Drug Approvals
View More FDA Approvals
Sign in to access additional FDA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
View More EMA Approvals
Sign in to access additional EMA-approved drug information with detailed regulatory data.
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
View More HSA Approvals
Sign in to access additional HSA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
View More NMPA Approvals
Sign in to access additional NMPA-approved drug information with detailed regulatory data.
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Tranexamic Acid Injection | 国药准字H20059504 | 化学药品 | 注射剂 | 12/17/2020 | |
| Tranexamic Acid Injection | 国药准字H20056986 | 化学药品 | 注射剂 | 6/12/2020 | |
| Tranexamic Acid Injection | 国药准字H20163442 | 化学药品 | 注射剂 | 10/12/2021 | |
| Tranexamic Acid Injection | 国药准字H14021956 | 化学药品 | 注射剂 | 4/20/2020 | |
| Tranexamic Acid Injection | 国药准字H20223387 | 化学药品 | 注射剂 | 6/16/2022 | |
| Tranexamic Acid Injection | 国药准字H20223764 | 化学药品 | 注射剂 | 10/25/2022 | |
| Tranexamic Acid Injection | 国药准字H43020565 | 化学药品 | 注射剂 | 12/11/2020 | |
| Tranexamic Acid Injection | 国药准字H19994139 | 化学药品 | 注射剂 | 12/11/2020 | |
| Tranexamic Acid Injection | 国药准字H33021422 | 化学药品 | 注射剂 | 6/5/2020 | |
| Tranexamic Acid Injection | 国药准字H20243924 | 化学药品 | 注射剂 | 6/4/2024 |
PPB Drug Approvals
View More PPB Approvals
Sign in to access additional PPB-approved drug information with detailed regulatory data.
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
View More TGA Approvals
Sign in to access additional TGA-approved drug information with detailed regulatory data.
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||