Histidine
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Histidine: From Amino Acid Nutrition Component to Gastroparesis
One-Sentence Summary
Histidine is an essential amino acid that appears in South African parenteral nutrition and dialysis products. No approved indication text is recorded for it in the supplied data. The TxGNN model predicts it may be effective for gastroparesis, but this rests on the model score alone, with 0 clinical trials and 0 publications supporting this specific prediction.
Quick Overview
| Item | Content |
|---|---|
| Predicted New Indication | Gastroparesis |
| TxGNN Prediction Score | 99.55% |
| Evidence Level | L5 |
| South Africa Market Status | Marketed |
| Number of SAHPRA Registrations | 10 |
| Recommended Decision | Hold |
The original indication is not shown because none of the SAHPRA registrations in the data carries approved indication text. The “amino acid nutrition component” label in the title is inferred from the product names (parenteral nutrition and peritoneal dialysis solutions), not from a regulatory indication.
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Based on known information, histidine is an amino acid ingredient in multi-component nutrition and dialysis solutions. It is not a stand-alone therapy with a defined pharmacological target.
No mechanistic link to gastroparesis could be established from the supplied data. No trials or publications were retrieved for this pairing. The high score reflects patterns in the TxGNN knowledge graph, not confirmed biology. It should be read as a hypothesis to test, not as a signal of benefit.
The other predictions in the pack are also weakly supported. Most are prediction-only (L5), and none has interventional human data. The one notable exception is sclerosing cholangitis (score 99.27%, L4). Its preclinical mouse studies suggest that histamine signalling, which histidine can feed into, promotes biliary damage and fibrosis. That points away from benefit and is a potential safety concern.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
South Africa Market Information
Ten SAHPRA registrations contain histidine. The five main ones are listed below. Approved indication text and manufacturer are not recorded in the data for any of them.
| Registration Number | Product Name | Dosage Form |
|---|---|---|
| Reg. No. 37/34/0243 | Nutrineal PD4 with 1.1% amino acids 2.5L | Infusion |
| Reg. No. 33/10.2.1/0271 | Adco-ipratropium (ni201) | Vial |
| Reg. No. 37/25.2/0503 | Oliclinomel N6 900E 2000ml | Infusion |
| Reg. No. 41/25/0757 | Nutriflex Lipid Peri | Infusion |
| Reg. No. 52/25/0739 | Numeta G13E | Infusion |
All listed products are infusions or vials, so an oral or enteral route relevant to gastroparesis has not been confirmed. Route compatibility has not been assessed.
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 gastroparesis prediction is model-only (L5), with no trials, no literature and no mechanistic rationale. The product labels and safety information needed for screening are also missing.
To proceed, the following is needed:
- SAHPRA Professional Information (warnings, contraindications, approved indications) for the registered products
- Mechanism of action data for histidine (e.g. from DrugBank)
- A targeted literature and trial search on histidine or amino acid supplementation in gastroparesis
- Assessment of route and formulation compatibility (oral or enteral versus the current infusion products)
- A safety review of the histamine-related preclinical findings before any hepatobiliary indication is considered
This report is for research reference only and does not constitute medical advice. Repurposing candidates require clinical validation before any clinical use.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.