Tolperisone
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
- Tolperisone
- Pharmacist Assessment Report
- Tolperisone: From Muscle Spasm (Muscle Relaxant Use) to Laubry-Pezzi Syndrome
- One-Sentence Summary
- Quick Overview
- Why is This Prediction Reasonable?
- Clinical Trial Evidence
- Literature Evidence
- India Market Information
- Safety Considerations
- Conclusion and Next Steps
- Disclaimer
Tolperisone: From Muscle Spasm (Muscle Relaxant Use) to Laubry-Pezzi Syndrome
One-Sentence Summary
Tolperisone is a centrally acting muscle relaxant that is marketed in India, but the approved indication text is not available in the data compiled for this report. The TxGNN model predicts it may be effective for Laubry-Pezzi syndrome, but there are 0 clinical trials and 0 publications supporting this prediction. The prediction is a network-based computation only and has no clinical backing.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not available (approved indication text is blank in all registrations; the drug is described as a centrally acting muscle relaxant) |
| Predicted New Indication | Laubry-Pezzi syndrome |
| TxGNN Prediction Score | 0.9992 |
| Evidence Level | L5 |
| India Market Status | Listed in a compiled Indian medicine price dataset (at least 20) – CDSCO approval status is not included in this data |
| Number of Listed Products | at least 20 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Based on known information, tolperisone is a centrally acting muscle relaxant that blocks voltage-gated sodium and calcium channels. Its use in muscle spasticity and spasm is the context in which it is marketed.
Laubry-Pezzi syndrome is a congenital cardiac condition (ventricular septal defect with aortic regurgitation). No plausible pathway links ion channel modulation in the central nervous system to this structural heart defect. The very high score comes from the TxGNN model (deep learning) and may reflect similarities the model learned between related diseases, not biological evidence, so the prediction should be treated with caution.
Other top-ranked predictions are also unsupported: Pierre Robin syndrome variants, a chromosome 7 partial deletion, valve diseases, orofacial clefting syndrome, general heart disease, a fucoglycosan synthesis disorder and interventricular septum aneurysm. Most are congenital or structural conditions with no apparent pharmacologic rationale for a muscle relaxant. The one indirect signal is a 2024 preclinical study of tolperisone in Parkinson’s disease (via MMP-9 inhibition), which is not relevant to the predicted indication.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available for Laubry-Pezzi syndrome.
India Market Information
Tolperisone has 20 valid single-ingredient registrations and no cancelled ones. Approved indication text is not available for any of them. Five main authorizations:
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 217373 | Tolson 450mg Tablet SR | Strip of 10 SR tablets | Not specified |
| 222709 | Tolpispam D 150mg/50mg Tablet | Strip of 10 tablets | Not specified |
| 200577 | Synaptol 100 Tablet (Sun Pharmaceutical Industries Ltd) | Strip of 10 tablets | Not specified |
| 215612 | Tolfree 150 Tablet (Zydus Cadila) | Strip of 10 tablets | Not specified |
| 90969 | Fentex 450mg Tablet SR | Strip of 10 SR tablets | Not specified |
All forms are oral tablets.
Safety Considerations
Please refer to the package insert for safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction is supported only by a network-based score, with no clinical trials, no relevant publications and no plausible mechanistic link to a congenital cardiac defect. The same holds for the other nine top-ranked predictions.
To proceed, the following is needed:
- Mechanism of action data for tolperisone
- Package insert warnings and contraindications from the India registrations, plus approved indication text
- Any preclinical or clinical evidence linking tolperisone to the predicted condition
- Reassessment of other candidate indications, for example neurological conditions where early preclinical signals exist (such as the MMP-9 findings in Parkinson’s disease), before further investment
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.