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Tranexamic Acid administered
Tranexamic Acid administered is a Antifibrinolytic agent Small molecule drug developed by Montefiore Medical Center. It is currently in Phase 3 development for Reduction of blood loss in surgical procedures, Treatment of heavy menstrual bleeding, Management of bleeding in hemophilia and other coagulation disorders.
Tranexamic acid inhibits the conversion of plasminogen to plasmin, thereby reducing fibrinolysis and promoting blood clot stability.
Tranexamic acid is a small molecule inhibitor of plasminogen, used to treat conditions such as hemorrhage of Cesarean Section and/or Perineal Wound, Postpartum Hemorrhage, Uterine Atony, Knee Osteoarthritis, and Arthropathy of Knee Joint. It has been studied in clinical trials for its effectiveness in reducing blood loss and incidence of postpartum hemorrhage during Caesarean Section.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Tranexamic Acid administered |
|---|---|
| Sponsor | Montefiore Medical Center |
| Drug class | Antifibrinolytic agent |
| Target | Plasminogen / Plasmin |
| Modality | Small molecule |
| Therapeutic area | Hematology / Hemostasis |
| Phase | Phase 3 |
Mechanism of action
Tranexamic acid is an antifibrinolytic agent that competitively inhibits plasminogen activation and plasmin activity. By blocking the breakdown of fibrin clots, it reduces excessive bleeding and promotes hemostasis. It is commonly used to reduce blood loss in surgical settings and to manage bleeding in various clinical conditions.
Approved indications
- Reduction of blood loss in surgical procedures
- Treatment of heavy menstrual bleeding
- Management of bleeding in hemophilia and other coagulation disorders
- Trauma-associated hemorrhage
Common side effects
- Thromboembolic events (deep vein thrombosis, pulmonary embolism)
- Nausea and vomiting
- Diarrhea
- Headache
- Visual disturbances
Key clinical trials
- Extended Oral Tranexamic Acid After Primary Total Knee Arthroplasty (NA)
- Prevention of Postpartum Hemorrhage With Tranexamic Acid (PHASE2)
- Effects of Red and Infrared Photobiomodulation in Rhinoplasty at a Single Centre (NA)
- Bleeding Reduction in Acute and Chronic Kidney Patients Having Surgery (BRACKETS) Pilot Trial (PHASE3)
- Tranexamic Acid for Bleeding Reduction During TURP Surgery (PHASE4)
- Extended Oral Tranexamic Acid After Anterior Cruciate Ligament Reconstruction (PHASE4)
- Epinephrine-Added Irrigation Versus Intravenous Tranexamic Acid in Arthroscopic Rotator Cuff Repair: A Prospective Randomized Controlled Trial (NA)
- Effect of Intravenous Tranexamic Acid on Visual Clarity During Shoulder Arthroscopy in the Beach Chair Position (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Tranexamic Acid administered CI brief — competitive landscape report
- Tranexamic Acid administered updates RSS · CI watch RSS
- Montefiore Medical Center portfolio CI
Frequently asked questions about Tranexamic Acid administered
What is Tranexamic Acid administered?
How does Tranexamic Acid administered work?
What is Tranexamic Acid administered used for?
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What does Tranexamic Acid administered target?
Related
- Drug class: All Antifibrinolytic agent drugs
- Target: All drugs targeting Plasminogen / Plasmin
- Manufacturer: Montefiore Medical Center — full pipeline
- Therapeutic area: All drugs in Hematology / Hemostasis
- Indication: Drugs for Reduction of blood loss in surgical procedures
- Indication: Drugs for Treatment of heavy menstrual bleeding
- Indication: Drugs for Management of bleeding in hemophilia and other coagulation disorders
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing