Nomegestrol Acetate
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
- Nomegestrol Acetate
- Nomegestrol Acetate: From Progestin Therapy to Candidiasis (Low-Confidence Prediction)
Nomegestrol Acetate: From Progestin Therapy to Candidiasis (Low-Confidence Prediction)
One-Sentence Summary
Nomegestrol acetate is a synthetic progestin (19-nor-progesterone derivative) used in hormonal contraception and menopausal hormone therapy; no original indication record is available in this evidence pack. The TxGNN model assigns a high score to Candidiasis as a possible new indication, but zero clinical trials and zero literature support this link, and the underlying pharmacology actually points in the opposite direction.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not available — no license records in this jurisdiction |
| Predicted New Indication | Candidiasis |
| TxGNN Prediction Score | 98.78% |
| Evidence Level | L5 (model prediction only, no corroborating studies) |
| EU Market Status | ✗ Not marketed (Not marketed) |
| Number of Authorizations | 0 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in this evidence pack. Based on general pharmacological knowledge, nomegestrol acetate is a selective progesterone receptor agonist with anti-gonadotropic and mild anti-androgenic activity, typically used as a component of combined hormonal contraceptives and in menopausal hormone therapy.
There is no known antifungal mechanism for nomegestrol acetate. More importantly, the direction of the known pharmacology runs counter to a therapeutic repurposing hypothesis: progestin and estrogen-progestin combinations are well documented to alter vaginal flora and are clinically associated with an increased risk of vulvovaginal candidiasis, not a treatment effect. The TxGNN score is numerically high, but the model’s own generated rationale characterizes this as likely reflecting a comorbidity/co-occurrence signal in the knowledge graph (drug associated with a condition it can cause or worsen) rather than a genuine causal-therapeutic relationship.
No clinical trial or published literature was found supporting an antifungal or candidiasis-treating role for this drug. This prediction should be treated as a candidate for model noise / false-positive filtering, not as a repurposing lead.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
EU Market Information
This drug currently has no marketing authorizations recorded in this jurisdiction (Not marketed / Not marketed, 0 licenses).
Safety Considerations
Please refer to the SmPC for safety information.
(Note: This evidence pack flags TFDA/regulatory label data — warnings and contraindications — as a Blocking data gap, meaning no formal safety review (S1) can currently be completed for this drug.)
Conclusion and Next Steps
Decision: Hold
Rationale: The candidiasis prediction has no clinical or literature support, and the drug’s known pharmacology (progestin-driven vaginal flora alteration) suggests the association runs opposite to a therapeutic effect — this is a mechanistic red flag, not a repurposing signal. The drug is also not currently marketed in this jurisdiction, and core safety data (warnings/contraindications) are a Blocking gap, so no S1 safety screening can be performed even if the indication signal were credible.
It is also worth noting that several other top-ranked predictions for this drug in the same evidence pack (e.g., thrombophilia-related conditions, thrombotic disease) show the same pattern — high TxGNN scores driven by proximity to adverse-effect associations (VTE risk) rather than genuine treatment efficacy. This suggests the candidate list for this drug is currently dominated by safety-signal contamination rather than efficacy signals, and warrants cautious interpretation as a set.
To proceed, the following is needed:
- TFDA/regulatory label data (warnings, contraindications) — currently a Blocking gap (DG001)
- Confirmed mechanism of action and original indication (DrugBank API query) — currently a High-severity gap (DG002)
- Any in vitro/in vivo evidence of antifungal or anti-Candida activity for nomegestrol acetate, if this lead is to be pursued further
- Explicit re-evaluation of whether “candidiasis” should be down-weighted or excluded as a known adverse-association artifact in the underlying knowledge graph
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.