Trospium
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Trospium: From Overactive Bladder to Irritable Bowel Syndrome
One-Sentence Summary
Trospium is a peripherally acting antimuscarinic (quaternary amine) that is established for bladder overactivity; the specific approved indication text is not included in the data compiled for this report. The TxGNN model predicts it may be effective for irritable bowel syndrome, but there are 0 clinical trials and only 1 loosely related publication (which does not study irritable bowel syndrome) supporting this direction. This is a model prediction only.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the available license data (mechanistically and in the data, linked to overactive bladder) |
| Predicted New Indication | Irritable bowel syndrome |
| TxGNN Prediction Score | 98.04% |
| Evidence Level | L5 |
| US Market Status | Cancelled only (no currently valid licenses) |
| Number of NDAs | 9 (all ANDAs, all cancelled) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism-of-action data is not available in the data compiled for this report. Based on known information, trospium is a peripherally acting antimuscarinic (quaternary amine). Its established use is reducing detrusor overactivity in overactive bladder by blocking muscarinic receptors.
Antimuscarinic drugs are used as antispasmodics in irritable bowel syndrome, so a plausible link exists through reduced gastrointestinal smooth muscle contraction. The mechanism is therefore potentially applicable.
However, the only publication linked to this prediction (PMID 33890538) concerns antimuscarinic use in older adults with dementia and overactive bladder, not irritable bowel syndrome. It provides no direct evidence. The high TxGNN score is a prediction only.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 33890538 | 2021 | Cohort | Current Medical Research and Opinion | Examined incidence and predictors of antimuscarinic use among older adults with dementia and overactive bladder. Not about irritable bowel syndrome, so it offers no direct support. |
US Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| ANDA091573 | Trospium Chloride (Bryant Ranch Prepack) | Tablet, film coated | Not stated; cancelled |
| ANDA206472 | Trospium Chloride (Macleods) | Tablet | Not stated; cancelled |
| ANDA091289 | Trospium Chloride (Golden State Medical Supply) | Capsule, extended release | Not stated; cancelled |
| ANDA213185 | Trospium Chloride (Bluepoint Laboratories) | Capsule, extended release | Not stated; cancelled |
| ANDA091688 | Trospium Chloride (Cipla USA) | Tablet, film coated | Not stated; cancelled |
All 9 licenses are single-ingredient and cancelled; the 5 shown are the first listed.
Safety Considerations
- Drug Interactions: 100 interactions were identified. The ones listed here are mostly Moderate and mainly involve other anticholinergic or sedating drugs, or opioids. Examples include botulinum toxin type A, fentanyl, codeine, tramadol, dihydrocodeine, alfentanil, chlorpheniramine, amitriptyline, aclidinium, amantadine, ethanol, ranitidine and metformin. Minor interactions include acetaminophen and hydrochlorothiazide.
Please refer to the package insert for warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction is supported only by the model score and a plausible antispasmodic mechanism. There are no clinical trials and no relevant literature on irritable bowel syndrome (L5). All US licenses are cancelled, and label safety information is missing.
To proceed, the following is needed:
- Review of the package insert for warnings and contraindications
- Detailed mechanism-of-action data
- A literature and trial search specific to antimuscarinics in irritable bowel syndrome
- Confirmation of the approved original indication
- Assessment of the US market and regulatory pathway, since no valid license currently exists
- Assessment of anticholinergic burden and interaction risk in the target population
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.