Tranexamic Acid
| Evidence Level: L4 | Predicted Indications: 10 |
Table of Contents
Tranexamic Acid: From Endometriosis to Amenorrhea
One-Sentence Summary
Tranexamic acid is an antifibrinolytic agent, originally associated with endometriosis (as recorded in the knowledge graph) and widely used to reduce bleeding. The TxGNN model predicts it may be effective for Amenorrhea, but this is supported by 0 clinical trials and only 2 indirect reviews. The prediction is best treated as a research question rather than an actionable repurposing candidate.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Endometriosis (per the knowledge graph; no approved indication text is available for the Singapore licences) |
| Predicted New Indication | Amenorrhea |
| TxGNN Prediction Score | 99.19% |
| Evidence Level | L4 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 6 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the data compiled for this report. Based on known pharmacology, tranexamic acid is a lysine analogue that blocks plasminogen binding to fibrin, which reduces fibrinolysis. It is established for heavy menstrual bleeding.
The high TxGNN score for amenorrhea probably reflects the drug's close association with menstrual disorders. However, amenorrhea means the absence of menses, so a drug that reduces bleeding does not treat it. The biological link is indirect. At most, tranexamic acid might play a role in menstrual suppression or prophylaxis, for example in women with haematological cancers, but that is not treatment of amenorrhea as a condition.
The other predicted indications weaken confidence in the model's output further. Several high-scoring predictions are thrombophilic conditions (heparin cofactor 2 deficiency, factor 5 excess with spontaneous thrombosis, antithrombin deficiency type 2). In these, an antifibrinolytic would be expected to increase thrombotic risk. This suggests the scores reflect pathway associations rather than therapeutic benefit.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 21701432 | 2011 | Review | Menopause | Evidence-based review of pharmacological therapy for abnormal uterine bleeding; nonhormonal options are effective and generally well tolerated. Indirect evidence only |
| 39043214 | 2024 | Review | J Oncol Pharm Pract | Systematic approach to menses prophylaxis and suppression in pre-menopausal women with haematological cancer; few comparative data. Indirect evidence only |
Neither article studies tranexamic acid for treating amenorrhea.
Singapore Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| SIN16551P | Tafixyl Solution for Injection 100 mg/ml | Injection, solution | Not available |
| SIN15167P | Medsamic Solution for Injection 100 mg/ml | Injection, solution | Not available |
| SIN15715P | Xamilux Injection 100 mg/ml | Injection, solution | Not available |
| SIN02488P | Cyklokapron Injection 100 mg/ml | Injection | Not available |
| SIN15052P | Haemostop Injection 100 mg/ml | Injection, solution | Not available |
A sixth licence, Cyklokapron Tablet 500 mg (SIN02487P, film-coated tablet), is also valid. All six licences are single-ingredient products. Both injectable and oral forms are available.
Safety Considerations
- Contraindications flagged in the knowledge graph (these come from the model's knowledge graph, not from label text): hypertension, anxiety and neurotic disorders, porphyria, liver disease, gallbladder disease, diabetes mellitus and related hyperglycaemia or ketoacidosis, brain oedema, hypertriglyceridaemia and hyperlipidaemia, female breast carcinoma, endometrial cancer, thrombophlebitis, migraine, coronary artery disease, obesity, stroke and cerebrovascular disorders.
- Drug Interactions: 35 interactions were identified; 20 are listed in the data compiled for this report.
- Major: oestrogens and hormonal contraceptives (ethinylestradiol, estradiol, conjugated estrogens, esterified estrogens, estrone, diethylstilbestrol, estramustine), progestogens (norethisterone, drospirenone, etonogestrel), carfilzomib, anti-inhibitor coagulant complex, and Factor IX complex (human).
- Moderate: thrombolytics (alteplase, anistreplase).
- Thrombosis concern: In principle, an antifibrinolytic could raise thrombotic risk in thrombophilic patients. The only retrieved article for heparin cofactor 2 deficiency (1991) describes drugs, particularly oral contraceptives, triggering thrombosis in congenital coagulation-inhibitor defects. That is a safety signal, not evidence of efficacy.
Package insert warnings and contraindications were not available, so please refer to the package insert for authoritative safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction rests on model score alone plus two indirect reviews, and there are no clinical trials. Biologically, a drug that reduces bleeding does not address absent menses, and the other top predictions point to thrombotic safety concerns rather than benefit.
To proceed, the following is needed:
- Package insert warnings, contraindications and approved indications from the HSA, which are currently missing and block safety screening
- Detailed mechanism of action data (for example from DrugBank)
- Clarification of the clinical question: whether the goal is menstrual suppression or prophylaxis (a plausible but different use) rather than treatment of amenorrhea
- Direct clinical evidence, such as trials or comparative studies, in the relevant population
- A thrombotic risk assessment, especially for patients on oestrogen or progestogen therapy
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.