Entacapone
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
- Entacapone
- Entacapone: From Parkinson’s Disease Adjunct Therapy to PLA2G6-Associated Neurodegeneration
Entacapone: From Parkinson’s Disease Adjunct Therapy to PLA2G6-Associated Neurodegeneration
One-Sentence Summary
Entacapone is a peripheral COMT inhibitor that extends levodopa exposure and is used as an adjunct in Parkinson’s disease. The TxGNN model predicts it may be effective for PLA2G6-associated neurodegeneration, but no clinical trials and no publications currently support this direction, so it is a model prediction only.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Adjunct to levodopa in Parkinson’s disease (the US license records supplied contain no indication text) |
| Predicted New Indication | PLA2G6-associated neurodegeneration |
| TxGNN Prediction Score | 99.76% |
| Evidence Level | L5 (model prediction only) |
| US Market Status | ✓ Marketed |
| Number of NDAs | 13 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Entacapone is a peripheral COMT (catechol-O-methyltransferase) inhibitor. It slows the breakdown of levodopa, so levodopa stays in the body longer. Detailed mechanism-of-action data were not available in the source records. The description here is based on the drug’s known class role.
PLA2G6-associated neurodegeneration is mainly a lipid-metabolism and neurodegenerative disorder. Only the dystonia-parkinsonism subtype has a loose dopaminergic rationale, which is where a levodopa-extending drug could conceivably help with symptoms. Beyond that subtype, no direct biological link between COMT inhibition and the disease can be verified.
The score of 0.998 therefore most likely reflects similarity within the knowledge graph (neurological disease neighborhood) rather than a confirmed mechanism. It should be treated as a hypothesis, not a finding.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
US Market Information
13 authorizations are on record; the 5 main ones are listed below. The records supplied do not include approved-indication text.
| Authorization Number | Product Name | Dosage Form | Manufacturer |
|---|---|---|---|
| NDA020796 | Entacapone | Tablet, film coated | Aphena Pharma Solutions - Tennessee, LLC |
| ANDA203437 | Entacapone | Tablet, film coated | Major Pharmaceuticals |
| ANDA212601 | Entacapone | Tablet, film coated | Alembic Pharmaceuticals Inc. |
| ANDA205792 | Entacapone | Tablet | Ajanta Pharma USA Inc. |
| ANDA203437 | Entacapone | Tablet, film coated | AvPAK |
All listed products are oral tablets.
Safety Considerations
Please refer to the package insert for safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction for PLA2G6-associated neurodegeneration rests on the model score alone. There are no trials or publications, and the mechanistic link is weak outside the dystonia-parkinsonism subtype.
To proceed, the following is needed:
- The package insert, to complete warnings and contraindications review
- Detailed mechanism-of-action data
- Literature and case-level evidence on entacapone in PLA2G6-associated dystonia-parkinsonism specifically
- Consider prioritizing the more coherent candidates from the same prediction set: juvenile parkinsonism (paralysis agitans, juvenile, of Hunt) and Lewy body dementia. Both share dopaminergic or synucleinopathy biology with Parkinson’s disease, though the current evidence for them is also preclinical or absent.
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.