Fingolimod
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Fingolimod: From Multiple Sclerosis to Borderline Ovarian Serous Tumor
One-Sentence Summary
Fingolimod (marketed originally as Gilenya) is a sphingosine-1-phosphate (S1P) receptor modulator used for relapsing multiple sclerosis. The TxGNN model’s top-ranked prediction for this drug is Borderline Ovarian Serous Tumor, but this specific candidate is currently supported by 0 clinical trials and 0 publications — it is a pure knowledge-graph score with no direct clinical or literature backing.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Multiple Sclerosis (relapsing forms) — not found in the supplied regulatory license data |
| Predicted New Indication | Borderline Ovarian Serous Tumor |
| TxGNN Prediction Score | 94.94% |
| Evidence Level | L5 |
| Market Status | Not marketed (Not marketed) |
| Number of Authorizations | 0 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism-of-action data was not available in this evidence pack (flagged as a High-severity data gap, DG002). Based on publicly known pharmacology, fingolimod is a sphingosine-1-phosphate receptor 1 (S1P1) modulator that causes internalization of S1P1 on lymphocytes, sequestering them in lymph nodes — its approved mechanism for multiple sclerosis is immunomodulatory, not antineoplastic.
The TxGNN score for borderline ovarian serous tumor derives purely from knowledge-graph embedding similarity — this node shares graph neighborhood structure with other ovarian tumor nodes rather than reflecting any direct trial or literature signal. Separately, the fingolimod analogue FTY720 has documented preclinical anti-tumor activity in malignant ovarian cancer cell lines and xenografts (via SphK1/S1P pathway inhibition), but that evidence pool attaches to other nodes in this same prediction set (ranks 5 and 8: “serous neoplasm” and “ovarian benign neoplasm”), not to the top-ranked borderline serous tumor entity itself. Borderline (low malignant potential) serous tumors have a distinct biology from the malignant epithelial ovarian cancer cell lines studied in the existing FTY720 literature, so mechanistic extrapolation to this specific entity is currently unsupported.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
Note: within this same prediction batch, related ovarian-tumor nodes have some preclinical support — “serous neoplasm” (1 paper, PMID 30120964) and “ovarian benign neoplasm” (8 papers, evidence level L4) — but none of that literature is attached to the top-ranked borderline serous tumor candidate reported here, and the “ovarian benign neoplasm” literature set actually studies malignant epithelial ovarian cancer models, suggesting a possible TxGNN node-labeling mismatch worth clarifying before further action.
Market Information
Fingolimod has no marketing authorization on record in this jurisdiction (market status: not marketed; 0 authorizations), so no license table is available.
Safety Considerations
Please refer to the SmPC for safety information. (TFDA label warnings/contraindications are an unresolved Blocking data gap — DG001 — and must be obtained before any safety evaluation can proceed.)
Conclusion and Next Steps
Decision: Hold
Rationale: The top-ranked prediction (borderline ovarian serous tumor) is supported only by knowledge-graph similarity, with zero clinical trials or publications; combined with an unresolved Blocking safety data gap (TFDA warnings/contraindications), this candidate does not meet the bar to proceed to safety screening (S1).
To proceed, the following is needed:
- TFDA label PDF (warnings, contraindications) — resolves DG001, currently Blocking
- Confirmed mechanism-of-action data from DrugBank — resolves DG002
- Direct preclinical or clinical evidence specific to borderline (low malignant potential) serous tumors, rather than extrapolation from malignant epithelial ovarian cancer models
- Clarification of the TxGNN node mapping for “ovarian benign neoplasm” (rank 8), since its attached literature describes malignant cell lines/xenografts — if that node is more accurately “ovarian cancer,” it is a stronger candidate (L4, Research Question) than the current top-ranked, evidence-free node
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.