NDAORALTABLETPriority Review
Approved
Nov 2009
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
LYSTEDA (tranexamic acid) by Molecular Devices is derivative, which diminishes the dissolution of hemostatic fibrin by plasmin. First approved in 2009.
Drug data last refreshed 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LYSTEDA (tranexamic acid) is an oral antifibrinolytic agent that inhibits the dissolution of blood clots by blocking plasmin's ability to bind to fibrin, thereby stabilizing the fibrin matrix. It is indicated for heavy menstrual bleeding as a primary indication, with off-label use across surgical, traumatic, and hemorrhagic conditions including trauma injury, postpartum hemorrhage, and various surgical procedures. The drug works by occupying lysine receptor binding sites on plasminogen, preventing fibrin degradation and preserving clot stability.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100), indicating shrinking team size and shift toward defensive positioning and generic transition planning.
Mechanism of Action
derivative, which diminishes the dissolution of hemostatic fibrin by plasmin. In the presence of tranexamic acid, the lysine receptor binding sites of plasmin for fibrin are occupied, preventing binding to fibrin monomers, thus preserving and stabilizing fibrin's matrix structure. The…
Pharmacologic Class:
Antifibrinolytic Agent
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Efficacy and Safety of Tranexamic Acid in Adult Liver Transplantation---ESTA Trial
Started Nov 2025
1,546 enrolled
Liver TransplantationTranexamic AcidEnd-stage Liver Disease (ESLD)
Tranexamic Acid for Reduction of Transfusion in Abdominal Surgery
Started Jun 2024
850 enrolled
Surgical Blood LossTransfusion-dependent AnemiaAbdomen Disease
Tranexamic Acid to Reduce Contraceptive-related Bleeding Side Effects
Started Jan 2024
65 enrolled
BleedingContraceptive Device; Complications
Tranexamic Acid to Reduce Blood Loss in Women Having Planned Cesarean Section
Started Nov 2023
68 enrolled
Cesarean SectionBlood Loss During Surgery
Tranexamic Acid for the Prevention of Postpartum Hemorrhage in Pregnant Women With Placenta Previa
Started Jul 2023
1,732 enrolled
Hemorrhage, PostpartumPlacenta Previa
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.