Enalaprilat
| Evidence Level: L5 | Predicted Indications: 1 |
Table of Contents
Enalaprilat: From an Injectable ACE Inhibitor to Primary Hereditary Glaucoma
One-Sentence Summary
Enalaprilat is an injectable ACE inhibitor marketed in the United States as generic injection products. The TxGNN model predicts it may be effective for primary hereditary glaucoma, but no clinical trials and no publications currently support this direction. The prediction rests on the model score alone.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the available US license records (the approved indication text is blank) |
| Predicted New Indication | Primary hereditary glaucoma |
| TxGNN Prediction Score | 99.09% |
| Evidence Level | L5 |
| US Market Status | ✓ Marketed |
| Number of NDAs | 3 license records (ANDAs, two unique numbers) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the record. Enalaprilat is an ACE inhibitor, so it acts on the renin-angiotensin system (RAS). A local RAS exists in ocular tissues (ciliary body, aqueous humor). Experimental work suggests that modulating it may affect aqueous humor dynamics and intraocular pressure. This is a plausible but unverified link.
Three factors weaken it:
- Disease biology: Primary hereditary (congenital) glaucoma is mainly a developmental anomaly of the trabecular meshwork and anterior chamber angle, often linked to genes such as CYP1B1 and LTBP2. It is usually treated surgically, not by drug-based pressure lowering.
- Formulation: Enalaprilat is available only as an intravenous injection. Its ocular penetration and suitability for chronic use are unknown.
- Data gaps: The mechanism-of-action record is incomplete, and no drug-interaction data was found.
The high score is most likely a knowledge-graph association. It should not be read as clinical support.
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 |
|---|---|---|---|
| ANDA075578 | Enalaprilat | Injection | Dr. Reddys Laboratories Inc |
| ANDA078687 | Enalaprilat | Injection | HF Acquisition Co LLC, DBA HealthFirst |
ANDA075578 appears twice in the source records and is shown once here. The approved indication text is blank in all records. All products are injectables.
Safety Considerations
Please refer to the package insert for safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction has a very high model score but no trials, no literature, and a weak biological fit. Congenital glaucoma is developmental and mainly surgical, and enalaprilat exists only as an IV product. There is not enough evidence to justify further investment.
To proceed, the following is needed:
- Package insert warnings and contraindications (a blocking gap for safety screening)
- Mechanism-of-action data from DrugBank
- Preclinical evidence that ACE inhibition changes aqueous outflow or intraocular pressure in relevant glaucoma models
- An assessment of ocular penetration and of whether a non-IV route (topical or oral ACE inhibitor) is realistic
- A literature review of RAS and ACE-inhibitor effects in glaucoma, particularly developmental forms
This report is for research reference only and does not constitute medical advice. Repurposing candidates require clinical validation before any application.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.