Pinaverium Bromide
| 證據等級: L5 | 預測適應症: 0 個 |
目錄
Pinaverium Bromide: Drug Repurposing Evaluation — Pending Data Resolution
One-Sentence Summary
Pinaverium bromide is a calcium-selective antispasmodic agent primarily indicated for functional gastrointestinal disorders, including irritable bowel syndrome (IBS). The TxGNN repurposing pipeline was unable to generate predicted new indications for this drug, as two critical upstream data gaps — missing DrugBank ID and mechanism of action (MOA) — prevent knowledge graph traversal. This report documents the current assessment status and the specific remediation steps required before a full repurposing evaluation can proceed.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Functional gastrointestinal disorders / IBS (general pharmacological knowledge; not confirmed in current Evidence Pack) |
| Predicted New Indication | No predictions available — pipeline incomplete |
| TxGNN Prediction Score | N/A |
| Evidence Level | Not assessable |
| Malaysia Market Status | ✓ Marketed |
| Number of Registrations | 2 |
| Recommended Decision | Hold |
Malaysia Market Information
The NPRA query (2026-03-27) confirmed 2 active registrations in Malaysia. However, the detailed license fields (authorization numbers, product names, dosage forms, and approved indications) were not populated in the current data extract and require a follow-up retrieval.
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| — | — | — | Not available in current extract |
| — | — | — | Not available in current extract |
To retrieve full license details, query the NPRA Product Registration database directly using the search term “PINAVERIUM BROMIDE”.
Safety Considerations
Please refer to the package insert for safety information.
No drug-drug interactions were identified (DDI query status: not found, 0 interactions). Key warnings and contraindications are currently unavailable pending package insert retrieval (Data Gap DG001 — Blocking severity).
Conclusion and Next Steps
Decision: Hold
Rationale: The TxGNN knowledge graph prediction pipeline requires a valid DrugBank ID to map Pinaverium Bromide onto the drug–disease knowledge graph. Without this mapping, no repurposing candidates can be scored or ranked, making a meaningful evidence evaluation impossible at this stage.
To proceed, the following is needed:
- [DG001 — Blocking] Retrieve the Malaysia-approved package insert from NPRA or the Dicetel® product label to extract approved indications, key warnings, and contraindications; this is required before safety pre-screening (Stage S1) can be initiated
- [DG002 — High] Obtain the DrugBank ID and full MOA description — search DrugBank for “pinaverium” (expected entry: DB06716) — to enable knowledge graph traversal and generate TxGNN repurposing candidates
- Re-run the TxGNN pipeline after resolving DG001 and DG002; expected outputs include repurposing candidate rankings, supporting clinical trial evidence, and literature citations
- Populate NPRA license details (authorization numbers, product names, dosage forms, approved indications) from the NPRA registration portal to complete the Malaysia regulatory section
- Verify market status and indication scope through official NPRA records to confirm whether current Malaysian approvals already cover any predicted new indications (which would simplify the regulatory pathway)
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.