Nomegestrol Acetate
| 證據等級: L5 | 預測適應症: 10 個 |
目錄
Nomegestrol Acetate: From Hormonal Contraception/HRT to Candidiasis
One-Sentence Summary
Nomegestrol acetate is a progestin (progesterone receptor agonist), commonly used in combined hormonal contraceptives and menopausal hormone therapy — though no original-indication or MOA data is on file here. The TxGNN model’s top-ranked prediction is Candidiasis, with a raw score of 98.78%, but this is supported by 0 clinical trials and 0 publications, and the drug’s own known pharmacology points the opposite direction (hormonal contraceptives are associated with increased, not decreased, candidiasis risk). This candidate should be treated as an unverified model output, not a repurposing opportunity.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in this evidence pack (general knowledge: progestin used in hormonal contraception / HRT) |
| Predicted New Indication | Candidiasis |
| TxGNN Prediction Score | 98.78% |
| Evidence Level | L5 |
| South Africa Market Status | Not marketed |
| Number of SAHPRA Registrations | 0 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available (flagged in this evidence pack as a High-severity data gap). Based on known pharmacology, nomegestrol acetate is a third-generation progestin, typically combined with an estrogen (e.g. 17β-estradiol) in oral contraceptives and hormone therapy.
The link between hormonal contraception and candidiasis is real, but it runs the opposite way to what would be needed to support this prediction: estrogen–progestin combinations are known to alter vaginal flora and are associated with increased vaginal candidiasis risk, not treatment of it. The rationale attached to this candidate in the evidence pack states this explicitly — no clinical trial or literature evidence supports a therapeutic hypothesis, and the biological direction argues against one.
This appears to be a case where TxGNN’s graph-similarity scoring picked up a real drug–disease association (adverse effect / risk signal) and surfaced it as if it were a treatment candidate. The same pattern recurs elsewhere in this evidence pack: predictions for antithrombin deficiency, heparin cofactor 2 deficiency, and factor V–related thrombosis are all conditions for which progestin/estrogen therapy is a contraindication, not a treatment — and the one candidate with actual trial and literature evidence (“thrombotic disease,” rank 9) shows the drug increasing venous thromboembolism (VTE) risk (per Bińkowska et al., 2022, PMID 36254131), again the opposite of a therapeutic signal.
Clinical Trial Evidence
Currently no related clinical trials registered.
(Note: two Phase 2/3 trials — NCT01656434, NCT01709318 — exist for nomegestrol acetate but concern contraceptive efficacy/safety, not candidiasis, and are not evidence for this indication.)
Literature Evidence
Currently no related literature available.
South Africa Market Information
No SAHPRA registrations are on record — market status is “Not marketed” with 0 licenses. No product, dosage form, or approved-indication data is available to summarise.
Safety Considerations
Please refer to the SAHPRA-approved Professional Information (PI) for safety information. Report adverse drug reactions to SAHPRA.
Additional context from this evidence pack (not from the drug’s formal safety fields, but directly relevant): literature retrieved for a different predicted indication (thrombotic disease) documents that estrogen–progestin combinations containing nomegestrol acetate carry a known venous thromboembolism risk (Bińkowska et al., 2022). This is a class-level safety signal worth carrying forward into any future evaluation of this drug, regardless of which indication is ultimately pursued.
Conclusion and Next Steps
Decision: Hold
Rationale:
- The top-ranked prediction (candidiasis) has zero supporting clinical trials or literature, and the drug’s known pharmacology suggests it would worsen rather than treat this condition — this is a model-only (L5) signal with a mechanistically implausible direction.
- A Blocking-severity data gap exists (TFDA/SAHPRA product-label warnings and contraindications are entirely missing), which by itself prevents any initial safety screening (S1) regardless of indication.
To proceed, the following is needed:
- SAHPRA-approved Professional Information (PI) — warnings, contraindications, DDI (currently a Blocking data gap)
- Confirmed mechanism of action data from DrugBank (currently a High-severity data gap)
- Original approved indication(s) for nomegestrol acetate, to properly assess similarity to any new candidate
- If this candidate is pursued further, a targeted literature/trial search specifically testing nomegestrol acetate against candidiasis (not merely co-occurrence data), since none currently exists
- Given the recurring risk-not-benefit pattern across this drug’s top 10 predictions, a broader review of whether TxGNN’s output for this drug reflects genuine repurposing signal or adverse-effect associations misclassified as efficacy signals
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.