Soybean Oil
| Evidence Level: L5 | Predicted Indications: 1 |
Table of Contents
Soybean Oil: From Parenteral Nutrition Lipid Source to Amenorrhea
One-Sentence Summary
Soybean oil is a lipid source used in intravenous fat emulsions (for example, Intralipid), but the data compiled for this report contain no approved indication text for it. The TxGNN model predicts it may be effective for amenorrhea, but there are currently 0 clinical trials and 0 publications supporting this direction.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not listed in the available data (the product forms are intravenous lipid emulsions, but no indication text is recorded) |
| Predicted New Indication | Amenorrhea |
| TxGNN Prediction Score | 99.61% |
| Evidence Level | L5 |
| US Market Status | Cancelled only (no currently valid authorizations) |
| Number of NDAs | 9 authorizations in total (all cancelled; includes 5 NDAs and 3 BLAs, as listed below) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. No original indications are recorded either, so the relationship between the original and new indications cannot be assessed from the data compiled for this report.
The very high TxGNN score (99.61%) is a computational knowledge-graph prediction only. Soybean oil is mainly a lipid and calorie source (for example in parenteral nutrition emulsions) and provides omega-6 fatty acids and phytosterols. One could speculate that amenorrhea related to low energy availability, such as functional hypothalamic amenorrhea, might be indirectly influenced by lipid supplementation, or that phytoestrogens might play a role. This is a hypothesis only. It is not supported by any evidence in the data and should not be treated as a finding.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
US Market Information
All 9 authorizations are cancelled. No approved indication text is recorded for any of them.
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| NDA020248 | Intralipid (Fresenius Kabi USA) | Emulsion | Not recorded |
| NDA018449 | Intralipid (Fresenius Kabi USA) | Emulsion | Not recorded |
| NDA017643 | Intralipid (Baxter Healthcare) | Emulsion | Not recorded |
| NDA019942 | Intralipid (Baxter Healthcare) | Emulsion | Not recorded |
| NDA019531 | NutriLipid I.V. Fat Emulsion (B. Braun) | Injection, solution | Not recorded |
Four further cancelled authorizations are not shown: NDA204508 (Clinolipid, Baxter) and three allergenic-extract BLAs (BLA103888, BLA103753, BLA101833; soybean food allergen products).
Safety Considerations
Please refer to the package insert for safety information. No drug interaction records were found, and no knowledge-graph contraindications were identified.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction rests only on a model score, with no registered clinical trials, no literature, no mechanism data and no recorded original indication. The drug has no currently valid US authorization, and the safety review cannot proceed because package insert information is missing.
To proceed, the following is needed:
- FDA package insert warnings and contraindications (a blocking gap for safety screening)
- Mechanism of action data (for example, from DrugBank)
- Original approved indication information for the lipid emulsion products
- A literature and trial search on lipid or nutritional supplementation in amenorrhea, particularly functional hypothalamic amenorrhea
- Assessment of route compatibility (intravenous emulsion versus any route needed for the new indication)
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.