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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.

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

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