Chloral Hydrate
| 證據等級: L5 | 預測適應症: 0 個 |
目錄
Chloral Hydrate: No Repurposing Candidates Generated — Evidence Pack Incomplete
One-Sentence Summary
Chloral hydrate (DrugBank: DB01563) is a historic sedative-hypnotic agent with no active marketing authorisation in the United Kingdom.
The TxGNN pipeline did not generate any repurposing predictions for this drug in the current run, and critical data — including mechanism of action, approved indications, and safety information — are absent from the Evidence Pack.
This report therefore serves as a data-gap notification rather than a full repurposing evaluation; a Hold decision is recommended until foundational data are recovered.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not available — no approved indication data in Evidence Pack |
| Predicted New Indication | None generated by TxGNN |
| TxGNN Prediction Score | N/A |
| Evidence Level | Not assessable |
| UK Market Status | Not marketed |
| Number of Marketing Authorisations | 0 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
No repurposing prediction is available for this drug in the current Evidence Pack (predicted_indications is empty). A mechanistic rationale therefore cannot be constructed at this stage.
Currently, detailed mechanism of action data is not available in the Evidence Pack. Based on general pharmacological knowledge, chloral hydrate is a central nervous system depressant historically classified as a sedative-hypnotic. Its use in modern clinical practice has declined substantially across most markets, including the United Kingdom, owing to a narrow therapeutic window and significant safety concerns. It is not currently licensed in the UK.
Until the TxGNN pipeline successfully generates candidate predictions — and until MOA, indication, and safety data are retrieved — a mechanistic rationale linking chloral hydrate to a new indication cannot be responsibly presented.
Clinical Trial Evidence
No predicted indication is available; accordingly, no disease-specific trial search has been performed.
Currently no related clinical trials can be listed for a repurposing candidate.
Literature Evidence
No predicted indication is available; accordingly, no disease-specific literature search has been performed.
Currently no related literature can be listed for a repurposing candidate.
UK Market Information
Chloral hydrate holds no current marketing authorisation with the MHRA and is not listed as a marketed product in the United Kingdom.
| Marketing Authorisation Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| — | No authorisations on record | — | — |
Note for pharmacists and clinicians: Chloral hydrate was previously available in the UK as an oral solution and suppository for short-term sedation, particularly in paediatric procedural settings, but licences have lapsed. Any use would require a Special Manufacturing (Specials) licence or unlicensed import. Reference the BNF (Section 4.1 — Hypnotics and Anxiolytics) and relevant MHRA guidance for current status.
Safety Considerations
All safety fields in the current Evidence Pack are flagged as data gaps. No drug–drug interaction data were returned from the DrugBank query.
Please refer to the SmPC (if a licensed product is identified) and the BNF for safety information. Report suspected adverse reactions via the Yellow Card Scheme (yellowcard.mhra.gov.uk).
Prescriber alert: Based on well-established published pharmacology, chloral hydrate carries risks of respiratory depression, hepatic and renal toxicity, dependence, and a narrow therapeutic index. These hazards are particularly relevant in elderly patients and those with pre-existing organ impairment. This information should be formally captured once the MHRA SmPC or equivalent source document is retrieved.
Conclusion and Next Steps
Decision: Hold
Rationale: The Evidence Pack for chloral hydrate is critically incomplete: zero repurposing predictions were generated, the drug holds no UK marketing authorisation, and all safety and mechanism-of-action fields are absent. There is no actionable evidence base on which to proceed with a repurposing assessment at this time.
To proceed, the following is needed:
- Resolve Data Gap DG002 (High severity): Retrieve mechanism of action from DrugBank API (DB01563) to enable mechanistic plausibility analysis.
- Resolve Data Gap DG001 (Blocking severity): Obtain the MHRA SmPC or equivalent UK product information to populate approved indication, key warnings, and contraindications fields.
- Investigate why
predicted_indicationsis empty: Confirm whether chloral hydrate is present in the TxGNN knowledge graph (data/node.csv) and whether its DrugBank ID maps correctly. Re-run the KG and DL prediction pipelines. - Clarify UK regulatory standing: Determine whether any Specials licence, hospital exemption, or MHRA orphan designation exists for chloral hydrate in the UK that may not appear in standard licence databases.
- DDI check: Re-query DrugBank and the BNF Appendix 1 for known interactions once the base drug record is confirmed. The current
not_foundstatus may reflect a query error rather than an absence of interactions. - Resubmit Evidence Pack: Once the above gaps are resolved, resubmit for a full v5 evaluation.
This report is generated for research purposes only and does not constitute medical advice. All drug repurposing candidates require clinical validation before any therapeutic application. Pages generated by this system include a YMYL disclaimer as required.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.