Amiloride
| Evidence Level: L5 | Predicted Indications: 6 |
Table of Contents
Amiloride: From Oral Potassium-Sparing Diuretic to Malignant Hypertensive Renal Disease
One-Sentence Summary
Amiloride is an oral tablet diuretic that is currently marketed in the United States. The TxGNN model predicts it may be effective for malignant hypertensive renal disease, with a score of 99.82%. However, there are 0 clinical trials and 0 publications for this indication, so the prediction rests on the model alone.
Quick Overview
| Item | Content |
|---|---|
| Predicted New Indication | Malignant hypertensive renal disease |
| TxGNN Prediction Score | 99.82% |
| Evidence Level | L5 (model prediction only) |
| US Market Status | ✓ Marketed |
| Number of NDAs | 4 (1 NDA and 3 ANDA-type authorizations) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
The source MOA field for this drug is not available. Based on the drug-level analysis, amiloride blocks the epithelial sodium channel (ENaC). It has a mild antihypertensive, potassium-sparing effect. This is plausible for volume-dependent hypertension, so the link to a hypertensive kidney condition is understandable.
There is an important caveat. Malignant hypertension with renal involvement is a hypertensive emergency, and it is normally managed with rapid-acting agents. A mild oral diuretic is unlikely to be a primary therapy. It could at most play a supporting role. The 0.998 score reflects knowledge-graph proximity, not confirmed clinical benefit.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
US Market Information
| Authorization Number | Product Name | Dosage Form | Manufacturer |
|---|---|---|---|
| ANDA070346 | Amiloride Hydrochloride | Tablet | Bryant Ranch Prepack |
| ANDA070346 | Amiloride Hydrochloride | Tablet | Endo USA, Inc. |
| ANDA079133 | Amiloride Hydrochloride | Tablet | Sigmapharm Laboratories, LLC |
| NDA018200 | Amiloride Hydrochloride | Tablet | Padagis US LLC |
All products are oral tablets. The approved indication text was not available in the records provided.
Safety Considerations
Please refer to the package insert for safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction has no supporting trials or literature (L5). The proposed condition is a hypertensive emergency, for which a mild oral diuretic is an unlikely primary therapy.
Among the other predicted indications in this Evidence Pack, only chronic pulmonary heart disease (rank 6, score 99.68%) reached the S1 “Research Question” stage. It has indirect heart-failure studies (L4) and a hyperkalemia safety signal that would need assessment. If the team wants to prioritize one direction for amiloride, that one is more promising than this rank 1 prediction.
To proceed, the following is needed:
- Package insert warnings and contraindications (blocking for safety screening)
- Mechanism of action data from DrugBank
- A targeted literature search on amiloride in malignant or hypertensive nephrosclerosis
- Clinical input on whether an add-on role is realistic in a hypertensive emergency setting
- Hyperkalemia and renal function risk assessment, since potassium retention matters in kidney disease
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.