LYSTEDA (tranexamic acid)
Tranexamic acid injection is an antifibrinolytic agent indicated for short-term use (2 to 8 days) in patients with hemophilia to reduce or prevent hemorrhage during and following tooth extraction. By decreasing the risk of bleeding in these surgical contexts, it reduces the necessity for factor replacement therapy. (Note: If referring specifically to the brand LYSTEDA, the indication would instead be the treatment of cyclic heavy menstrual bleeding.)
How LYSTEDA Works
Tranexamic acid is a synthetic lysine derivative that inhibits fibrinolysis by reversibly binding to the lysine-binding sites on plasminogen. This prevents plasminogen from interacting with fibrin, thereby blocking its conversion to plasmin and the subsequent degradation of the fibrin matrix. By stabilizing the clot structure, tranexamic acid preserves the hemostatic plug and prevents premature dissolution.
Details
- Status
- Prescription
- First Approved
- 2009-11-13
- Routes
- ORAL
- Dosage Forms
- TABLET
LYSTEDA Approval History
What LYSTEDA Treats
2 indicationsLYSTEDA is approved for 2 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hemophilia
- Hemorrhage
LYSTEDA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to LYSTEDA
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
215 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07582341 | MS 33-5-2025 | Ph 4 | completed | Combined Intravenous and Irrigation Tranexamic Acid During Percutaneous Nephrolithotomy |
| NCT05774717 | 221035 | Ph 1 | recruiting | Tranexamic Acid in Rhinoplasty: Perioperative Bleeding, Edema and Ecchymosis |
| NCT02314988 | AAAQ6795 201409111 | Ph 2, Ph 3 | recruiting | Tranexamic Acid to Reduce Blood Loss in Spine Surgery |
| NCT06414031 TATRA | TATRA 01KG2305, 2023-509970-43-01 | Ph 3 | recruiting | Tranexamic Acid for Reduction of Transfusion in Abdominal Surgery |
| NCT06599762 MYELO-CAN:TXA | CHI-001-1 | Ph 2 | recruiting | Evaluation of Tranexamic Acid in Myelodysplastic Syndromes and Acute Myeloid Leukemia |
| NCT02702128 LEFORTEXACYL | 2014_68 2015-002175-24 | Ph 3 | completed | Preventive EXACYL® on Perioperative Bleeding During Orthognathism of Maxillary Surgery |
| NCT06422273 | 2024-0552 | Ph 3 | enrolling by invitation | Protest Trial: TXA vs Saline |
| NCT07501884 REDUCER | Pro2026000612 Pro2026000612 | Ph 4 | not yet recruiting | REDUCER Trial (TXA in Urethroplasty) |
| NCT05370820 Optimum OB-TXA | INOVA-2024-39 R01HD110109 | Ph 2 | recruiting | Prevention of Postpartum Hemorrhage With Tranexamic Acid |
| NCT07460518 TXA-TURP | HMIMV-TXA-TURP-2025 | Ph 4 | not yet recruiting | Tranexamic Acid for Bleeding Reduction During TURP Surgery |
| NCT04905901 | 17300595 | Ph 3 | recruiting | Nebulized Tranexamic Acid in Sinus Surgery |
| NCT03552705 | 46092 CDMRP-PR171647 | Ph 2 | recruiting | The Effects of Tranexamic Acid on Joint Inflammation and Cartilage Health in Anterior Cruciate Ligament Injured Patients |
| NCT05053867 | 2019-0991 NCI-2021-09676 | Ph 3 | recruiting | A Randomized Controlled Trial of Inhaled Tranexamic Acid for the Treatment of Pulmonary Hemorrhage in Cancer Patients |
| NCT05345613 | 0017-22-ASF | Ph 4 | recruiting | Tranexamic Acid During Colonic Endoscopic Resection Procedures |
| NCT04448184 PATH | 2068 | Ph 3 | recruiting | Platelet Transfusions in Hematopoietic Stem Cell Transplantation (The PATH III Trial) |
| NCT05323149 | 17101636 | Ph 3 | recruiting | Tranexamic Acid in Traumatic Brain Injury |
| NCT04192435 TRIGS | 087 | Ph 4 | completed | Tranexamic Acid to Reduce Infection After Gastrointestinal Surgery |
| NCT05075200 TXA-Dosing results posted | 1567 | Ph 2 | completed | Tranexamic Acid Dosing for Major Joint Replacement Surgery |
| NCT07263841 | 435/RC/KEMU | Ph 2 | active not recruiting | Comparison of Effectiveness of Tranexamic Acid Mesotherapy Versus Glutathione Mesotherapy in Post Burn Facial Hyperpigmentation |
| NCT07261930 TXA-FemNail | MskRRH-ORTHO-2025-001 | Ph 4 | completed | Effectiveness of Tranexamic Acid in Reducing Blood Loss During Femoral Nail Surgery |
| NCT06086444 | 16/2023 | Ph 4 | completed | Tranexamic Acid in Abdominoplasty. |
| NCT05945680 | 17/2023 | Ph 4 | completed | Tranexamic Acid in Breast Esthetic Surgery. |
| NCT06379724 | 150349 | Ph 4 | recruiting | Burn Study- Tranexamic Acid Versus Thrombin in Split Thickness Skin Graft |
| NCT05807074 results posted | 228012 NCI-2023-02817 | Ph 4 | terminated | Impact of Topical Tranexamic Acid in Breast Reconstruction |
| NCT06000423 | OHSU IRB 25761 | Ph 4 | completed | Tranexamic Acid to Reduce Contraceptive-related Bleeding Side Effects |
| NCT04910464 | 17300607 | Ph 3 | recruiting | Early Tranexamic Acid and Modulating the Inflammatory Response in Sepsis |
| NCT06820177 | 811490 | Ph 4 | recruiting | Tranexamic Acid for Second Trimester Dilation and Evacuation and Bleeding Outcomes |
| NCT07098780 | PH/IRB/2023/011 | Ph 4 | recruiting | Role of Tranexamic Acid in Reducing Hemorrhagic Events in Bariatric Surgery |
| NCT07078942 | 0127/68 COA 0685/2025 | Ph 4 | not yet recruiting | Prophylactic Intravenous Tranexamic Acid on Perioperative Blood Loss in Pregnant Women Undergoing Cesarean Section |
| NCT04117243 | 280391 | Ph 2 | completed | Tranexamic Acid Versus Sublingual Misoprostol in Reducing Blood Loss During Elective CS in High Risk Cases |
| NCT06997796 Bloody SIMPLE | 001 | Ph 1, Ph 2 | recruiting | Treatment of Nosebleeds in the Emergency Department With Powder Tranexamic Acid |
| NCT06983886 | MURA2025/288 | Ph 1, Ph 2 | not yet recruiting | The Effect of Local Infiltration of Tranexamic Acid on Postoperative Blood Loss in Orthognathic Surgery |
| NCT06644079 | UF-CUT-003 | Ph 2 | withdrawn | Window of Opportunity Study of Topical Tranexamic Acid for Cutaneous Squamous Cell Carcinoma |
| NCT06657924 | IRB 24-896 | Ph 2 | recruiting | Preoperative Tranexamic Acid (TXA) to Prevent Bleeding in Patients Undergoing Major Colorectal Surgery |
| NCT04625530 | 2020-01194; sp20Amstad | Ph 3 | withdrawn | Perioperative Management in Gynaecological Carcinoma Surgery |
| NCT06920264 | 20-12-1991 | Ph 1 | completed | Effect of Tranexamic Acid (TXA) Administered Prior to Shoulder Arthroscopy on Postoperative Pain Medication Usage: A Randomized Controlled Trial |
| NCT05811676 TRAPP | MR-44-23-016012（TRAPP） | Ph 3 | completed | Tranexamic Acid for the Prevention of Postpartum Hemorrhage in Pregnant Women With Placenta Previa |
| NCT03287336 results posted | IND134701 UL1TR001876, KL2TR001877 | Ph 2 | completed | Prevention of Postpartum Hemorrhage With Tranexamic Acid |
| NCT05899465 PRIME | PRIME | Ph 3 | recruiting | Perioperative Treatment With Tranexamic Acid in Melanoma |
| NCT06754371 | LY2024-172-B | Ph 4 | recruiting | Prophylactic Tranexamic Acid Reduces Postpartum Hemorrhage |
| NCT05562609 I'M-WOMAN | IMWOMAN | Ph 3 | recruiting | Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women At Higher Risk |
| NCT05554211 | STU00214745 | Ph 2 | withdrawn | Tranexamic Acid Usage in Bilateral Mastectomy to Reduce Post-surgical Drainage |
| NCT03505723 POISE-3 | 2018.02.08 | Ph 3 | completed | PeriOperative ISchemic Evaluation-3 Trial |
| NCT06023212 | 2022_LHY | Ph 1, Ph 2 | recruiting | Tranexamic Acid Use for Bleeding Prevention in the Surgical Treatment of Metastatic Spinal Tumor in Lung Cancer Patients |
| NCT02561923 | CR107832 39039039NAP1004 | Ph 1 | completed | A Study to Assess the Independent Effects of 4-Factor Prothrombin Complex Concentrate and Tranexamic Acid on Bleeding/Pharmacodynamics in Healthy Participants |
| NCT06419075 TEXAS | 23-0273 | Ph 4 | withdrawn | Tranexamic Acid in Vaginal Reconstructive Surgery |
| NCT03714360 | S-20150072 | Ph 4 | completed | The Effect of Tranexamic Acid. A Randomised Study of Patients Undergoing Elective Lumbar Spine Surgery. |
| NCT04089865 results posted | 2019-0882 | Ph 4 | completed | Oral Versus Intravenous Tranexamic Acid |
| NCT04410042 results posted | TXAKIDS NCI-2020-02984 | Ph 3 | terminated | Tranexamic Acid Use to Reduce Blood Transfusion in Pediatric Cancer Patients Undergoing Limb Salvage Procedure |
| NCT06479161 | SFH 24-05 | Ph 2 | recruiting | Effects of Oral Tranexamic Acid Following Total Knee Arthroplasty |
Showing 50 of 215 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LYSTEDA FDA Label Details
Indications & Usage
FDA Label (PDF)LYSTEDA is indicated for the treatment of Hemophilia; Hemorrhage.
Track LYSTEDA with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.