Tranexamic Acid: clinical trials recruiting now
6
Recruiting trials
13
Conditions studied
2
US states with sites
5
Countries
FDA drug label
- FDA-approved
- Yes. Tranexamic Acid appears in the FDA drug-label database. Marketed as Tranexamic Acid.
- Drug class
- Antifibrinolytic Agent (FDA established pharmacologic class)
- Boxed warning
- The FDA label for Tranexamic Acid carries a boxed warning (the FDA's most serious warning). See the full label for details.
FDA-approved use
Tranexamic acid injection is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. Tranexamic acid injection is an antifibrinolytic indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. ( 1 )
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Presence of Particulate Matter: Piece of metal found in a vial — AuroMedics Pharma LLC | Class III (FDA: unlikely to cause harm) | Ongoing | 2022-09-26 |
| Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity. — Amring Pharmaceuticals Inc | Class III (FDA: unlikely to cause harm) | Terminated | 2023-06-12 |
| Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP. — Mylan Institutional LLC | Class I (FDA: reasonable probability of serious harm or death) | Terminated | 2020-08-17 |
| Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity. — AVKARE LLC | Class III (FDA: unlikely to cause harm) | Ongoing | 2023-06-13 |
Phase breakdown
Phase 1 1
Phase 2 2
Phase 3 2
Phase 4 2
Conditions being studied
Recruiting trials involving Tranexamic Acid
- A Randomized Controlled Trial of Inhaled Tranexamic Acid for the Treatment of Pulmonary Hemorrhage in Cancer Patients
- Perioperative Treatment With Tranexamic Acid in Melanoma
- Role of Tranexamic Acid in Reducing Hemorrhagic Events in Bariatric Surgery
- The Effects of Tranexamic Acid on Joint Inflammation and Cartilage Health in Anterior Cruciate Ligament Injured Patients
- Tranexamic Acid During Colonic Endoscopic Resection Procedures
- Tranexamic Acid Use for Bleeding Prevention in the Surgical Treatment of Metastatic Spinal Tumor in Lung Cancer Patients
Common questions
Is Tranexamic Acid FDA-approved?
Yes, marketed as Tranexamic Acid. Its FDA label carries a boxed warning.
How many recruiting trials involve Tranexamic Acid?
6 recruiting trials across 13 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.