Ampicillin Trihydrate

證據等級: L5

預測適應症: 0 個

Ampicillin Trihydrate: Repurposing Evaluation — Insufficient Data to Generate Prediction

One-Sentence Summary

Ampicillin Trihydrate is a broad-spectrum penicillin-class antibiotic widely used for bacterial infections globally. However, no TxGNN repurposing predictions were generated for this drug in the current data cycle, and zero SAHPRA registrations were identified under this name. This evaluation cannot proceed to a standard evidence review until two blocking data gaps — regulatory labelling and mechanism of action data — are resolved.

Quick Overview

Item	Content
Original Indication	Not available (no SAHPRA registration records found)
Predicted New Indication	No predictions generated
TxGNN Prediction Score	N/A
Evidence Level	N/A — prediction pipeline incomplete
South Africa Market Status	Not Marketed
Number of SAHPRA Registrations	0
Recommended Decision	Hold

Why No Prediction Was Generated

The TxGNN pipeline requires two minimum inputs to produce repurposing candidates: a linked DrugBank ID and at least one mapped approved indication. Both are absent from this Evidence Pack.

Specifically, the data pipeline returned:

DrugBank ID: Not resolved — the name “Ampicillin Trihydrate” was queried against DrugBank on 26 March 2026 and returned one result, but the identifier was not written back into the record. Without this anchor, the knowledge graph cannot locate the drug node and therefore cannot generate disease predictions.
Approved indications: No SAHPRA registrations were found under the submitted name. It is possible that ampicillin products are registered in South Africa under the INN “Ampicillin” alone, or under specific brand names, rather than “Ampicillin Trihydrate.” A targeted SAHPRA database search is needed to confirm this.
Mechanism of action: No MOA data was retrieved. This prevents any mechanistic plausibility analysis.

Note for the data team: Ampicillin Trihydrate is the trihydrate salt form of ampicillin. The DrugBank entry for ampicillin (DB00415) covers the parent compound. The pipeline should attempt name normalisation to the parent INN before concluding that no DrugBank ID exists.

Clinical Trial Evidence

Currently no related clinical trials registered for this predicted indication — no indication was predicted.

Literature Evidence

Currently no related literature available — no indication was predicted.

South Africa Market Information

No SAHPRA registrations were found for “Ampicillin Trihydrate.” The submitted name may not match the registered product names. Common alternative search terms to check include:

Ampicillin (parent INN)
Ampicillin sodium (injectable salt form)
Brand names marketed in South Africa (e.g., Penbritin, Totapen)

If registrations exist under alternative names, those records should be linked to this candidate before re-running the pipeline.

Safety Considerations

Please refer to the SAHPRA-approved Professional Information (PI) for safety information. Report adverse drug reactions to SAHPRA.

Conclusion and Next Steps

Decision: Hold

Rationale: The prediction pipeline could not complete because the DrugBank linkage failed and no regulatory registration records were found. Without these two inputs, no repurposing candidates can be evaluated and no safety or evidence review is meaningful.

To proceed, the following is needed:

Resolve DrugBank ID: Normalise “Ampicillin Trihydrate” → “Ampicillin” and confirm the DrugBank ID is DB00415; write this back into the drug.drugbank_id field before re-running
Search SAHPRA under alternative names: Query the SAHPRA online medicines register using “Ampicillin,” “Ampicillin sodium,” and known brand names to locate existing registration records
Retrieve approved indications from SAHPRA label: Once registrations are found, extract the approved indication text from the Professional Information (PI) document (resolves data gap DG001 — currently Blocking)
Retrieve MOA from DrugBank: Once DB00415 is confirmed, pull the mechanism of action via the DrugBank API (resolves data gap DG002 — currently High severity)
Re-run TxGNN prediction pipeline after the above four items are complete

This report reflects data as of 2026-04-04. Results are for research purposes only and do not constitute medical advice. Drug repurposing candidates require clinical validation before any therapeutic application.

Disclaimer

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