Tranexamic acid
- Generic Name
- Tranexamic acid
- Brand Names
- Cyklokapron, Lysteda
- Drug Type
- Small Molecule
- Chemical Formula
- C8H15NO2
- CAS Number
- 1197-18-8
- Unique Ingredient Identifier
- 6T84R30KC1
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
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 Approved Products
Product Name | Manufacturer | Route | Strength | Approved | NDC Code |
|---|---|---|---|---|---|
INTRAVENOUS | 100 mg in 1 mL | 2021/06/25 | 68083-160 | ||
INTRAVENOUS | 100 mg in 1 mL | 2021/02/25 | 67850-041 | ||
INTRAVENOUS | 100 mg in 1 mL | 2021/03/01 | 0517-0960 | ||
INTRAVENOUS | 100 mg in 1 mL | 2021/02/28 | 65145-106 | ||
INTRAVENOUS | 100 mg in 1 mL | 2022/11/05 | 70771-1085 | ||
INTRAVENOUS | 100 mg in 1 mL | 2016/11/16 | 67457-197 | ||
INTRAVENOUS | 1 g in 10 mL | 2022/10/04 | 23155-524 | ||
INTRAVENOUS | 100 mg in 1 mL | 2023/12/22 | 70860-407 | ||
INTRAVENOUS | 100 mg in 1 mL | 2023/12/05 | 60505-6169 | ||
INTRAVENOUS | 100 mg in 1 mL | 2021/06/15 | 42571-189 |
EMA Approved Products
Medicine Name | EMA Number | Auth. Holder | Country | Drug Type | Status | Issued | Opinion | Revision |
|---|
No EMA products found
No EMA products found for this drug
HSA Approved Products
Product Name | Manufacturer | Dosage Form | Strength | Approved | Approval No. |
|---|---|---|---|---|---|
INJECTION, SOLUTION | 100mg/ml | 2016/07/21 | SIN15052P | ||
TABLET, FILM COATED | 500 mg | 1989/03/09 | SIN02487P | ||
INJECTION, SOLUTION | 100mg/ml | 2017/01/26 | SIN15167P | ||
INJECTION, SOLUTION | 100 mg/mL | 2022/07/14 | SIN16551P | ||
INJECTION, SOLUTION | 100mg/ml | 2019/06/12 | SIN15715P | ||
INJECTION | 100 mg/ml | 1989/03/09 | SIN02488P |
NMPA Approved Products
Product Name | Approval No. | Manufacturer | Dosage Form | Trade Name | Strength | Type | Status | Date | Import |
|---|---|---|---|---|---|---|---|---|---|
国药准字H20040488 | 注射剂 | 卡维安 | 1.0g(按C8H15NO2计) | Chemical Drug | Approved | 2015/07/16 | Domestic | ||
国药准字H20040695 | 注射剂(冻干粉针剂 ) | 力达非 | 0．5g | Chemical Drug | Approved | 2020/03/20 | Domestic | ||
国药准字H20031170 | 注射剂(冻干) | 荷莫塞 | 0.2g | Chemical Drug | Approved | 2020/04/09 | Domestic | ||
国药准字H20060098 | 注射剂(冻干) | 荷莫塞 | 0.5g | Chemical Drug | Approved | 2020/04/09 | Domestic | ||
国药准字H20040696 | 注射剂(冻干粉针剂 ) | 力达非 | 0．25g | Chemical Drug | Approved | 2020/03/20 | Domestic | ||
国药准字H20031171 | 注射剂(冻干) | 荷莫塞 | 0.4g | Chemical Drug | Approved | 2020/04/09 | Domestic | ||
国药准字H20031172 | 注射剂 | 荷莫塞 | 1.0g | Chemical Drug | Approved | 2020/04/01 | Domestic | ||
国药准字H20040747 | N/A | N/A | 0.25g | Chemical Drug | Approved | 2010/09/30 | Domestic | ||
国药准字H20030587 | 注射剂(冻干) | N/A | 0.5g | Chemical Drug | Approved | 2020/09/13 | Domestic | ||
国药准字H20040748 | N/A | N/A | 0.5g | Chemical Drug | Approved | 2010/09/30 | Domestic |
PPB Approved Products
Product Name | Registration Code | Company | Category | Sale Type | Reg. Date |
|---|---|---|---|---|---|
HK-00708 | Part 1, Schedule 1 & Schedule 3 Poison | POM | 1978/08/24 | ||
HK-56754 | yung shin co ltd | Part 1, Schedule 1 & Schedule 3 Poison | POM | 2008/07/04 | |
HK-18524 | wilcome pharmaceutical co ltd | Part 1, Schedule 1 & Schedule 3 Poison | POM | 1982/11/12 | |
HK-44408 | unicorn laboratories o/b american unicorn laboratories limited | Part 1, Schedule 1 & Schedule 3 Poison | POM | 1999/03/01 | |
HK-00704 | Part 1, Schedule 1 & Schedule 3 Poison | POM | 1978/08/24 | ||
HK-22792 | Part 1, Schedule 1 & Schedule 3 Poison | POM | 1984/07/21 | ||
HK-00715 | Part 1, Schedule 1 & Schedule 3 Poison | POM | 1978/08/23 |
TGA Approved Products
Product Name | ARTG ID | Sponsor | Status | Reg. Date | Ingredient |
|---|---|---|---|---|---|
272728 | Active | 2017/01/30 | tranexamic acid | ||
202786 | Active | 2014/04/23 | tranexamic acid | ||
228945 | Active | 2015/11/09 | tranexamic acid | ||
214485 | Active | 2014/08/05 | tranexamic acid | ||
222350 | Active | 2015/03/02 | tranexamic acid | ||
272730 | Active | 2017/01/30 | tranexamic acid | ||
228946 | Active | 2015/11/09 | tranexamic acid | ||
263047 | Active | 2017/08/07 | tranexamic acid | ||
263038 | Active | 2017/08/07 | tranexamic acid | ||
263044 | Active | 2017/08/07 | tranexamic acid |