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tranexamic acid (Exacyl®)
tranexamic acid (Exacyl®) is a Antifibrinolytic Small molecule drug developed by Institut Kassab d'Orthopédie. It is currently in Phase 3 development for Heavy menstrual bleeding, Menorrhagia, Hemorrhage during and following surgery. Also known as: Exacyl.
Tranexamic acid works by inhibiting the activation of plasminogen to plasmin, thereby preventing the breakdown of fibrin clots.
Tranexamic acid, also known as Exacyl, is used to prevent or reduce bleeding in various medical conditions, including peri-operative hemorrhage, surgery, and hematoma. It has been studied in clinical trials for its effectiveness in preventing bleeding during and after certain surgical procedures, such as orthognathism of maxillary surgery.
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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). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| 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 (Exacyl®) |
|---|---|
| Also known as | Exacyl |
| Sponsor | Institut Kassab d'Orthopédie |
| Drug class | Antifibrinolytic |
| Target | Lysine receptor on plasminogen |
| Modality | Small molecule |
| Therapeutic area | Oncology, Surgery |
| Phase | Phase 3 |
Mechanism of action
This results in a reduction of bleeding and hemorrhage. Tranexamic acid is a synthetic derivative of the amino acid lysine, which is a key component in the formation of fibrin clots. By binding to lysine receptors on plasminogen, tranexamic acid prevents the activation of plasminogen to plasmin, thereby stabilizing fibrin clots and reducing bleeding.
Approved indications
- Heavy menstrual bleeding
- Menorrhagia
- Hemorrhage during and following surgery
- Hemorrhage in patients with trauma
- Hemorrhage in patients with cancer
Common side effects
- Nausea
- Vomiting
- Headache
- Dizziness
- Fatigue
Key clinical trials
- Platelet Transfusions in Hematopoietic Stem Cell Transplantation (The PATH III Trial) (PHASE3)
- Safety of Use and Efficacy of Pandora for Patients Suffering From Gonarthrosis (PANDORA2) (NA)
- Management of Coagulopathy During Orthotopic Liver Transplantation. Comparison Between ROTEM-based Management and Standard Biological Assessment. (NA)
- Effectiveness of Tranexamic Acid in Reducing Blood Loss During Femoral Nail Surgery (PHASE4)
- TRial to EvaluAte Tranexamic Acid Therapy in Thrombocytopenia (PHASE3)
- Effectiveness of Oral Melatonin vs Oral Tranexamic Acid in the Treatment and Recurrence of Melasma (PHASE4)
- Tranexamic Acid to Reduce Blood Loss in Spine Surgery (PHASE2, PHASE3)
- Perioperative Management in Gynaecological Carcinoma Surgery (PHASE3)
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 (Exacyl®) CI brief — competitive landscape report
- tranexamic acid (Exacyl®) updates RSS · CI watch RSS
- Institut Kassab d'Orthopédie portfolio CI
Frequently asked questions about tranexamic acid (Exacyl®)
What is tranexamic acid (Exacyl®)?
How does tranexamic acid (Exacyl®) work?
What is tranexamic acid (Exacyl®) used for?
Who makes tranexamic acid (Exacyl®)?
Is tranexamic acid (Exacyl®) also known as anything else?
What drug class is tranexamic acid (Exacyl®) in?
What development phase is tranexamic acid (Exacyl®) in?
What are the side effects of tranexamic acid (Exacyl®)?
What does tranexamic acid (Exacyl®) target?
Related
- Drug class: All Antifibrinolytic drugs
- Target: All drugs targeting Lysine receptor on plasminogen
- Manufacturer: Institut Kassab d'Orthopédie — full pipeline
- Therapeutic area: All drugs in Oncology, Surgery
- Indication: Drugs for Heavy menstrual bleeding
- Indication: Drugs for Menorrhagia
- Indication: Drugs for Hemorrhage during and following surgery
- Also known as: Exacyl
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing