Ropinirole
| Evidence Level: L3 | Predicted Indications: 10 |
Table of Contents
Ropinirole: From Restless Legs Syndrome to Attention Deficit-Hyperactivity Disorder
One-Sentence Summary
Ropinirole is a dopamine agonist originally used to treat restless legs syndrome and Parkinson disease. The TxGNN model predicts it may be effective for attention deficit-hyperactivity disorder (ADHD), but currently there are 0 registered clinical trials and 8 publications (only 1 of which, a 2026 paper, is potentially a randomized trial and cannot yet be verified) related to this direction.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Restless legs syndrome; Parkinson disease |
| Predicted New Indication | Attention deficit-hyperactivity disorder |
| TxGNN Prediction Score | 99.99% |
| Evidence Level | L3 |
| US Market Status | Cancelled only (all 7 listed ANDAs are cancelled) |
| Number of NDAs | 7 (all ANDA generic applications, 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, ropinirole is a D2/D3 dopamine receptor agonist. Its efficacy in restless legs syndrome and Parkinson disease is established, and mechanistically it may be applicable to ADHD, which is associated with dopaminergic dysregulation.
The link between the original and new indication is the frequent co-occurrence of restless legs syndrome and ADHD. A literature review suggests the two conditions may share dopaminergic and iron-metabolism pathways. A case report describes a 6-year-old boy with ADHD and restless legs/periodic limb movement who had limited response to methylphenidate; ropinirole improved both his ADHD symptoms and sleep problems.
The most direct evidence would be a 2026 publication (PMID 42640474) that appears to be a randomized, double-blind, placebo-controlled trial of ropinirole added to methylphenidate in 66 children and adolescents aged 6-17. Only a truncated abstract was available, so the results could not be verified. Evidence is therefore held at L3 until it is confirmed.
Other highly ranked predictions (for example schizophrenia, myopia and several rare genetic disorders) have either only preclinical or indirect evidence, or no evidence at all, and are not developed further here.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 42640474 | 2026 | RCT (suspected from title; unverified) | Eur Child Adolesc Psychiatry | 8-week, double-blind, placebo-controlled trial of ropinirole added to methylphenidate in 66 children and adolescents with ADHD; results not available in the compiled data |
| 15866437 | 2005 | Case report | Pediatr Neurol | A 6-year-old with ADHD and restless legs syndrome had significant improvement in ADHD symptoms and sleep with ropinirole |
| 16218085 | 2005 | Review | Sleep | Review of the association between restless legs syndrome and ADHD, possible mechanisms, and shared treatments |
| 18656214 | 2008 | Review | Rev Neurol | Overview of restless legs syndrome (a sensorimotor disorder affecting 2-3% of Western populations) |
| 34182128 | 2021 | Preclinical | Pharmacol Res | Dopamine D4 receptor variants and α2A adrenoceptor heteromerization, relevant to ADHD and impulse control |
| 24992083 | 2014 | Clinical study (indirect) | Clin Neuropharmacol | Piribedil versus pramipexole and ropinirole on vigilance in Parkinson disease patients with daytime sleepiness; not ADHD |
| 30950895 | 2019 | Safety report | Cornea | Corneal edema in 3 patients exposed to dopaminergic agents |
| 17483695 | 2007 | Animal model | J Neuropathol Exp Neurol | Mouse model of restless legs syndrome involving iron deprivation and dopamine pathway lesions |
US Market Information
All 7 listed authorizations are cancelled, and no active US marketing authorization is shown. The data compiled for this report contains no approved indication text for any of them.
| Authorization Number | Product Name | Dosage Form | Status |
|---|---|---|---|
| ANDA090135 | ropinirole (Glenmark) | Film-coated tablet | Cancelled |
| ANDA078110 | ropinirole hydrochloride (Solco Healthcare) | Film-coated tablet | Cancelled |
| ANDA079165 | Ropinirole (Marlex) | Film-coated tablet | Cancelled |
| ANDA090429 | Ropinirole (Alembic) | Film-coated tablet | Cancelled |
| ANDA090869 | Ropinirole hydrochloride (AvKARE) | Film-coated extended-release tablet | Cancelled |
Safety Considerations
- Contraindication signals from the knowledge graph (not label text): multiple system atrophy, postural orthostatic tachycardia syndrome, orthostatic hypotension, hypotensive disorder, drug-induced dyskinesia, liver failure, psychotic disorder, schizophreniform disorder, schizoaffective disorder, mental disorder.
- Drug Interactions: 100 interactions were found. The moderate-level ones include morphine (including liposomal), cimetidine, dronabinol, nabilone, obeticholic acid, metoclopramide and opium. Other listed interactions (for example calcitriol, phentermine, pantoprazole, glimepiride) have unknown severity.
- Other signals from the literature: a register study in Sweden found increased risk of gambling disorder with ropinirole, pramipexole and aripiprazole. Corneal edema has also been reported with dopaminergic agents. Both are relevant for a pediatric impulsivity-related indication.
Please refer to the package insert for the full warnings and contraindications, which were not available in the data compiled for this report.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction score is high and there is a plausible dopaminergic link, supported by one case report and a possible 2026 randomized trial. However, there are no registered trials, the key study is unverified, there is no active US marketing authorization, and label safety data and mechanism data are missing.
To proceed, the following is needed:
- Retrieve and verify the full text of PMID 42640474 (design, primary outcomes, results, adverse events)
- Obtain the FDA package insert warnings and contraindications to allow safety screening
- Obtain detailed mechanism of action data
- Search trial registries for registered or ongoing ADHD studies of ropinirole
- Assess pediatric safety, including impulse-control and gambling signals, and the regulatory path given that all US authorizations are cancelled
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.