Amisulpride
| 證據等級: L5 | 預測適應症: 0 個 |
目錄
Amisulpride: Repurposing Evaluation — No TxGNN Predictions Available
One-Sentence Summary
Amisulpride (DB06288) is an atypical antipsychotic with 4 registered products in the Malaysian market. The current Evidence Pack contains no TxGNN repurposing predictions, and critical data fields — including mechanism of action, approved indications, and safety warnings — are absent. This evaluation cannot proceed beyond a preliminary status assessment until data collection is completed.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not retrieved from current data |
| Predicted New Indication | Not available |
| TxGNN Prediction Score | Not available |
| Evidence Level | — (No predictions generated) |
| Malaysia Market Status | ✓ Marketed |
| Number of Registrations | 4 |
| Recommended Decision | Hold |
Why Are No Predictions Available?
Amisulpride could not generate TxGNN predictions in this cycle due to two unresolved data gaps that block the pipeline:
1. Missing mechanism of action (MOA): The DrugBank API query returned a result (query log ID 2, 2026-03-27), but MOA fields were not populated in the Evidence Pack. Without confirmed mechanistic data, the knowledge graph cannot establish disease-link pathways to candidate repurposing targets.
2. Empty approved indication fields: All 4 NPRA-registered licenses returned blank indication text. Without a baseline disease anchor, the system cannot perform disease-similarity scoring or filter candidate predictions.
From published medical literature, amisulpride is known as a selective dopamine D2/D3 receptor antagonist. At standard antipsychotic doses (400–800 mg/day), it reduces positive and negative symptoms of schizophrenia by blocking postsynaptic dopamine receptors. At ultra-low doses (5–25 mg), it preferentially acts on presynaptic autoreceptors, which underpins its well-documented antiemetic properties — a mechanism that resulted in U.S. FDA approval for postoperative nausea and vomiting (PONV) in 2020 (brand name: Barhemsys®). Once MOA and indication data are formally captured, a meaningful TxGNN prediction run is expected to be feasible.
Malaysia Market Information
The NPRA query (2026-03-27) confirmed 4 registered products, but product-level details were not returned in this data cycle. The table below cannot be populated until a secondary NPRA data pull is completed.
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| (data not retrieved) | (data not retrieved) | (data not retrieved) | (data not retrieved) |
Note: NPRA returned a successful query with 4 results, but all license record fields (product name, dosage form, manufacturer, approved indication) are empty strings. A re-query targeting individual product monographs or package insert PDFs is required.
Safety Considerations
Please refer to the package insert for safety information.
Key warnings, contraindications, and drug interaction data were not available in this Evidence Pack. NPRA package inserts should be downloaded and parsed as the primary remediation step.
Conclusion and Next Steps
Decision: Hold
Rationale: No TxGNN predictions were generated, and all three core evaluation inputs — approved indication, mechanism of action, and safety profile — are missing. There is insufficient evidence to assess repurposing potential or safety feasibility at this stage.
To proceed, the following is needed:
- NPRA package insert retrieval: Download PDF monographs for all 4 registered products to extract approved indications, key warnings, and contraindications (Data Gap DG001 — Blocking severity)
- DrugBank API re-query: Retrieve mechanism of action, pharmacodynamics, and drug interaction data for DB06288 (Data Gap DG002 — High severity)
- TxGNN pipeline re-run: After resolving DG001 and DG002, re-execute the KG prediction and DL prediction pipelines to generate candidate repurposing indications
- NPRA product detail verification: Confirm whether all 4 registrations share the same indication (e.g., schizophrenia only) or whether a low-dose antiemetic indication (PONV) is separately registered in Malaysia
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.