Tranexamic Acid
| Evidence Level: L3 | Predicted Indications: 1 |
Table of Contents
Tranexamic Acid: From Haemorrhage Control to Amenorrhea
One-Sentence Summary
Tranexamic acid is a well-established antifibrinolytic agent generally used to control or reduce excessive bleeding (e.g. heavy menstrual bleeding, surgical and traumatic haemorrhage). The TxGNN model predicts a possible association with Amenorrhea, but this direction is currently supported only by 2 indirectly related publications and no registered clinical trials, so the evidence base is thin.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Haemorrhage / excessive bleeding (antifibrinolytic use) — based on general pharmacological knowledge; the Evidence Pack contains no UK marketing authorisation record to confirm this |
| Predicted New Indication | Amenorrhea |
| TxGNN Prediction Score | 99.19% |
| Evidence Level | L3 |
| UK Market Status | Not marketed |
| Number of Marketing Authorisations | 0 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the Evidence Pack. Based on general pharmacological knowledge, tranexamic acid is a synthetic lysine analogue that competitively inhibits plasminogen activation, thereby reducing fibrinolysis and limiting blood loss. This mechanism is well established for conditions involving excessive or abnormal bleeding, most notably heavy menstrual bleeding, surgical haemorrhage and trauma-related bleeding.
The relationship between the original bleeding-control use and the predicted indication of amenorrhea (absence of menstruation) is not straightforward, and on the surface appears directionally opposite: tranexamic acid is used to reduce menstrual blood loss, not to suppress menstruation altogether. The supporting literature offers a plausible but indirect link — both papers discuss the broader clinical management of abnormal uterine bleeding and menstrual suppression, including the use of nonhormonal antifibrinolytic agents alongside hormonal regimens in patients (e.g. those with haematologic malignancy) who require menstrual suppression to avoid bleeding complications during treatment-related cytopenia. It is possible that TxGNN’s knowledge graph captured this co-occurrence within the shared “menstrual bleeding disorder management” neighbourhood rather than a direct causal treatment effect on amenorrhea itself.
Given this ambiguity, the mechanistic plausibility should be treated as low-to-moderate, and the prediction warrants closer scrutiny before any further evaluation.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 21701432 | 2011 | Review | Menopause (New York, N.Y.) | Evidence-based review of pharmacological therapies for abnormal uterine bleeding, comparing nonhormonal agents (including antifibrinolytics) and hormonal options; selection depends on aetiology, bleeding severity, fertility needs and menopausal status |
| 39043214 | 2024 | Review | Journal of Oncology Pharmacy Practice | Systematic review of menses prophylaxis and suppression strategies in pre-menopausal patients with haematologic cancer, noting a paucity of comparative data between available agents in the cancer treatment setting |
UK Market Information
No UK marketing authorisation is on record for tranexamic acid in this Evidence Pack; market status is listed as Not marketed with 0 authorisations recorded.
Safety Considerations
Please refer to the SmPC and BNF for safety information. Report suspected adverse reactions via the Yellow Card Scheme.
Conclusion and Next Steps
Decision: Hold
Rationale: There are no registered clinical trials and only two review-level publications with an indirect (and mechanistically somewhat counterintuitive) link to the predicted indication. Combined with missing MOA data, missing safety data, and no confirmed UK marketing authorisation, the current evidence is insufficient to progress this candidate.
To proceed, the following is needed:
- Confirmed mechanism of action (MOA) data from DrugBank
- SmPC/BNF-sourced key warnings, contraindications and drug interaction data
- Direct clinical trial or observational evidence specifically evaluating tranexamic acid for menstrual suppression/amenorrhea, rather than for reducing menstrual bleeding
- Clarification of study type/tier for the two cited publications (currently marked “pending” in the Evidence Pack)
- Confirmation of whether tranexamic acid holds any UK marketing authorisation under any brand name
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.