Pinaverium
| Evidence Level: L5 | Predicted Indications: 1 |
Table of Contents
- Pinaverium
- Pharmacist Assessment Report
- Pinaverium: From Irritable Bowel Syndrome to Benign Prostatic Hyperplasia
- One-Sentence Summary
- Quick Overview
- Why is This Prediction Reasonable?
- Clinical Trial Evidence
- Literature Evidence
- Canada Market Information
- Safety Considerations
- Conclusion and Next Steps
- Disclaimer
Pinaverium: From Irritable Bowel Syndrome to Benign Prostatic Hyperplasia
One-Sentence Summary
Pinaverium is a gut-selective calcium channel blocker, generally used for irritable bowel syndrome (IBS) and related gastrointestinal spasm. The TxGNN model predicts it may be effective for Benign Prostatic Hyperplasia (BPH). At present there are no registered clinical trials and no publications supporting this direction, so it rests on a computational prediction alone.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the Health Canada licence data compiled for this report (general pharmacology: IBS / gastrointestinal spasm) |
| Predicted New Indication | Benign prostatic hyperplasia |
| TxGNN Prediction Score | 0.9922 |
| Evidence Level | L5 |
| Canada Market Status | Marketed (marketed DINs: 4 of 4) |
| Number of DINs | 4 (marketed: 4) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the data compiled for this report. Based on general pharmacology, pinaverium is a gastrointestinal-selective L-type calcium channel blocker with antimuscarinic-like effects in the gut. Its established use is in IBS.
Calcium channel blockade could plausibly reduce smooth muscle tone in the prostate, bladder neck and urethra, which is relevant to lower urinary tract symptoms in BPH. This is a hypothesis only, inferred from general pharmacology rather than from supplied evidence.
There is also an important caveat. Pinaverium is highly gut-selective and poorly absorbed systemically, so it is unclear whether it would reach adequate concentrations in genitourinary tissue. The high TxGNN score (0.9922) is a computational output and is not clinical evidence.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
Canada Market Information
| DIN | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 01950592 | DICETEL | Not listed | Not listed |
| 02469677 | PINAVERIUM | Not listed | Not listed |
| 02469685 | PINAVERIUM | Not listed | Not listed |
| 02230684 | DICETEL | Not listed | Not listed |
All four licences are valid single-ingredient products.
Safety Considerations
Please refer to the package insert for safety information. No drug-interaction records were found in the data compiled for this report.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction is supported only by a model score, with no clinical trials or publications. The mechanistic link is hypothetical, and pinaverium’s poor systemic absorption raises doubt that it could act on prostatic tissue. Safety label data are also missing.
To proceed, the following is needed:
- Health Canada package insert (warnings, contraindications, approved indications, dosage forms), which is a blocking gap for safety screening
- Mechanism of action data from DrugBank
- Pharmacokinetic data on genitourinary tissue exposure
- Preclinical or early-phase studies on prostatic or urethral smooth muscle effects
- Comparison against established BPH therapies (alpha-blockers, 5-alpha-reductase inhibitors) to define any added value
- Assessment of route and formulation compatibility
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.