Isoleucine
| Evidence Level: L5 | Predicted Indications: 1 |
Table of Contents
Isoleucine: From Parenteral Nutrition Component to Gastroparesis
One-Sentence Summary
Isoleucine is an essential branched-chain amino acid. In South Africa it is registered mainly as a component of parenteral nutrition and dialysis solutions, and no approved indication text is available. The TxGNN model predicts it may be relevant to Gastroparesis, but there are 0 clinical trials and 0 publications supporting this direction, so it rests on model prediction alone.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the registration data (registered products are nutrition and dialysis solutions) |
| Predicted New Indication | Gastroparesis |
| TxGNN Prediction Score | 99.32% |
| Evidence Level | L5 |
| South Africa Market Status | Marketed |
| Number of SAHPRA Registrations | 11 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Isoleucine is an essential amino acid used as a nutritional component, mainly in parenteral nutrition and peritoneal dialysis products. No original indication is recorded for it as a single agent.
No mechanistic link to gastroparesis can be established from the data supplied. Possible connections through nutritional status, gastric motility signalling or metabolic pathways are speculative. Nothing in the supplied trials or literature supports them.
The high TxGNN score (0.993) is a knowledge-graph prediction only and does not count as clinical evidence. The graph path behind the prediction should be reviewed before any hypothesis is formed.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
South Africa Market Information
Five of the 11 registrations are shown. All are multi-component products, not single-ingredient isoleucine.
| Registration Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| Reg. No. 37/34/0243 | Nutrineal PD4 with 1.1% amino acids 2.5L | Infusion | Not stated in registration data |
| Reg. No. 33/10.2.1/0271 | Adco-ipratropium (ni201) | Vial | Not stated in registration data |
| Reg. No. 37/25.2/0503 | Oliclinomel N6 900E 2000ml | Infusion | Not stated in registration data |
| Reg. No. 41/25/0757 | Nutriflex Lipid Peri | Infusion | Not stated in registration data |
| Reg. No. 52/25/0739 | Numeta G13E | Infusion | Not stated in registration data |
Adco-ipratropium is an ipratropium product and would not normally contain isoleucine. This entry may be a data-mapping error and should be checked against the SAHPRA record.
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 has no supporting clinical trials or literature (L5), and no mechanism of action or original indication is available. The registered South African products are multi-component nutrition solutions, and their PI safety data have not been reviewed.
To proceed, the following is needed:
- Mechanism of action data (for example from DrugBank) to test whether a plausible link to gastroparesis exists
- Review of the knowledge-graph path behind the gastroparesis prediction
- SAHPRA package insert warnings and contraindications for the registered products (currently blocking safety screening)
- Verification of the Adco-ipratropium registration mapping
- Route-compatibility assessment, since the registered forms are intravenous infusion or dialysis solutions
- A literature and trial search for isoleucine or branched-chain amino acids in gastroparesis, to establish whether any real evidence exists
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.