Lorazepam

Evidence Level: L5 Predicted Indications: 10

Table of Contents

  1. Lorazepam
  2. Lorazepam: From Its Approved Use to Trigeminal Nerve Neoplasm
    1. One-Sentence Summary
    2. Quick Overview
    3. Why is This Prediction Reasonable?
    4. Clinical Trial Evidence
    5. Literature Evidence
    6. US Market Information
    7. Safety Considerations
    8. Conclusion and Next Steps
    9. Disclaimer

## Pharmacist Assessment Report

Lorazepam: From Its Approved Use to Trigeminal Nerve Neoplasm

One-Sentence Summary

Lorazepam is a benzodiazepine that is currently marketed in the United States. The source data does not list its original approved indication. The TxGNN model predicts it may be effective for trigeminal nerve neoplasm, but 0 clinical trials and 0 publications support this prediction, so it rests on the graph-based score alone.


Quick Overview

Item Content
Original Indication Not listed in the source data
Predicted New Indication Trigeminal nerve neoplasm
TxGNN Prediction Score 99.87%
Evidence Level L5
US Market Status ✓ Marketed
Number of NDAs 20
Recommended Decision Hold

Why is This Prediction Reasonable?

Detailed mechanism of action data is not available in the source data. Lorazepam is known as a positive allosteric modulator of the GABA-A receptor. It enhances inhibitory neurotransmission and produces sedative, anxiolytic and anticonvulsant effects.

Trigeminal nerve neoplasm is a nerve-sheath tumour. The prediction is difficult to justify mechanistically. Lorazepam has no known antitumour activity, and no trial or publication links it to this condition.

The high score (99.87%, model rank 4026) therefore reflects a pattern in the knowledge graph, not biological or clinical support. This candidate should be treated as a model artifact until independent evidence appears.


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 Approved Indication
ANDA072926 Lorazepam (PD-Rx Pharmaceuticals) Tablet Not listed
ANDA078203 Lorazepam (Proficient Rx) Tablet Not listed
ANDA078203 Lorazepam (RemedyRepack) Tablet Not listed
ANDA072928 Lorazepam (Golden State Medical Supply) Tablet Not listed
NDA214826 LOREEV XR (Almatica Pharma) Extended-release capsule Not listed

The 20 authorizations include ANDAs (generics) as well as NDAs. Oral tablets, extended-release capsules and injections are all marketed.


Safety Considerations

Please refer to the package insert for safety information.


Conclusion and Next Steps

Decision: Hold

Rationale: The prediction has no trials or literature behind it, and lorazepam has no plausible antitumour mechanism. The evidence level is L5 (model prediction only).

To proceed, the following is needed:

  • Any preclinical or clinical signal linking GABA-A modulation to trigeminal nerve tumours
  • The label’s approved indications and mechanism of action, to define the baseline for repurposing
  • Package insert warnings and contraindications (dependence, respiratory depression with opioids or alcohol, falls in the elderly)

Note: The second-ranked prediction, insomnia, has much more support. It has L3 evidence, including two older clinical studies of lorazepam in chronic insomnia (PMID 10220122 and 3280615). Whether it counts as repurposing or an established use should be checked against the label. It may be a better candidate to evaluate first.

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.



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