Repaglinide

證據等級: L5 預測適應症: 0

目錄

  1. Repaglinide
  2. Repaglinide: Drug Repurposing Evaluation — Incomplete Evidence Pack (No TxGNN Predictions Available)
    1. One-Sentence Summary
    2. Quick Overview
    3. Why Is This Evaluation Incomplete?
    4. Germany Market Information
    5. Safety Considerations
    6. Conclusion and Next Steps
    7. Disclaimer

## 藥師評估報告

Repaglinide: Drug Repurposing Evaluation — Incomplete Evidence Pack (No TxGNN Predictions Available)


One-Sentence Summary

Repaglinide (DB00912) is a meglitinide-class short-acting insulin secretagogue indicated for Type 2 Diabetes Mellitus. This Evidence Pack (v4, data cutoff 2026-04-20) contains no TxGNN predicted indications, which makes a standard repurposing evaluation impossible at this stage. Critical data gaps exist across MOA documentation, safety information, and Germany market status — all must be resolved before the evaluation can proceed.


Quick Overview

Item Content
Original Indication Type 2 Diabetes Mellitus (meglitinide class insulin secretagogue; source: DrugBank DB00912)
Predicted New Indication Not available — predicted_indications array is empty
TxGNN Prediction Score Not available
Evidence Level N/A
Germany Market Status Not marketed (0 authorizations on record)
Number of Authorizations 0
Recommended Decision Hold — insufficient data to evaluate

Why Is This Evaluation Incomplete?

The Evidence Pack contains two blocking gaps that prevent a standard repurposing report from being generated:

1. No TxGNN predicted indications. The predicted_indications field is an empty array. Without a candidate disease target, none of the standard sections — clinical trial mapping, literature review, mechanistic rationale, or cytotoxicity assessment — can be populated. This may indicate the TxGNN pipeline has not yet run for this drug, or that results were filtered out before this pack was assembled.

2. Mechanism of action (MOA) data is missing (DG002, severity: High). Repaglinide is known to close ATP-sensitive potassium channels on pancreatic β-cells, stimulating glucose-dependent insulin secretion. However, this information is not present in the Evidence Pack and has been flagged as a data gap. The remediation path (DrugBank API query) has been identified but not yet executed.

3. Safety data is entirely absent (DG001, severity: Blocking). All key_warnings, contraindications, and DDI entries carry [Data Gap] or not_found status. This is classified as a Blocking gap in the meta section, meaning the pipeline should not advance to safety screening (S1) without first downloading and parsing the package insert PDF from the TFDA/BfArM official source.


Germany Market Information

No marketing authorizations for Repaglinide are currently registered in this Evidence Pack. The taiwan_regulatory (BfArM) query returned 0 results on 2026-03-29.

Note: Repaglinide-containing products (e.g., NovoNorm®) are approved in several markets globally. The absence of records here likely reflects a data sourcing gap rather than true non-approval. This should be verified directly against the BfArM product database before concluding "not marketed."


Safety Considerations

All safety fields in this Evidence Pack are [Data Gap]. Per reporting rules, no safety items are listed.

Please refer to the package insert for safety information. Specific attention should be paid to hypoglycaemia risk, hepatic impairment contraindication, and CYP2C8/CYP3A4-mediated drug interactions, which are well-established for this drug class.


Conclusion and Next Steps

Decision: Hold

Rationale: The Evidence Pack is structurally incomplete — there are no TxGNN predictions to evaluate, and two blocking data gaps (safety data, MOA) prevent the evaluation pipeline from advancing to any downstream stage.

To proceed, the following is needed:

  • Re-run TxGNN pipeline for Repaglinide (DB00912) and populate predicted_indications with at least the top-ranked disease candidates and their scores.
  • Resolve DG001 (Blocking): Download and parse the Repaglinide package insert PDF from TFDA/BfArM to extract key warnings and contraindications.
  • Resolve DG002 (High): Query the DrugBank API for the full MOA entry and populate original_moa.
  • Verify Germany market status: Cross-check BfArM product database for NovoNorm® or equivalent Repaglinide authorizations; the current 0-count result is likely a data gap, not an actual regulatory absence.
  • Re-generate Evidence Pack at v5+ once the above gaps are closed, then re-run this report template with populated predicted_indications[0].

    Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.



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