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Neupro (ROTIGOTINE)
Rotigotine stimulates dopamine receptors in the brain, which may help treat Parkinson's disease and Restless Legs Syndrome.
Neupro (Rotigotine) is a nonergot dopamine agonist developed by UCB Inc, targeting the D(2) dopamine receptor. It is a small molecule modality approved by the FDA in 2007 for the treatment of Parkinson's disease and Restless Legs Syndrome. Neupro is a patented medication with no generic manufacturers available. Key safety considerations include its potential for skin reactions and the need for regular patch replacement. As a dopamine agonist, Neupro works by mimicking the action of dopamine in the brain, helping to alleviate symptoms of Parkinson's disease and Restless Legs Syndrome.
At a glance
| Generic name | ROTIGOTINE |
|---|---|
| Sponsor | UCB |
| Drug class | Nonergot Dopamine Agonist [EPC] |
| Target | dopamine receptors |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 2007 |
Mechanism of action
Rotigotine is a non-ergoline dopamine agonist that works by stimulating dopamine receptors in the brain, particularly in the caudate-putamen region. This stimulation is thought to help alleviate symptoms of Parkinson's disease and Restless Legs Syndrome, though the exact mechanisms are not fully understood.
Approved indications
- Parkinson's disease
- Restless legs
Common side effects
- Nausea
- Somnolence
- Application and instillation site reactions
- Dizziness
- Vomiting
- Disturbances in initiating and maintaining sleep
- Hyperhidrosis
- Visual disturbance
- Anorexia
- Peripheral edema
- Dyskinesia
- Fatigue
Key clinical trials
- Safety of RotigotiNe in Patients With Autosomal Dominant Polycystic Kidney Disease (PHASE2)
- Transdermal Rotigotine as Adjunct to Behavioral Therapy for Cocaine Use Disorder (PHASE2)
- Quality Improvement and Practice Based Research in Neurology Using the EMR (PHASE4)
- Adhesion and Safety of Rotigexole Compared to Neupro® (NA)
- Infusion of Apomorphine: Long-term Safety Study (PHASE3)
- Sleep Efficiency Assessed by Polysomnography (PSG Sleep Lab Testing) in Advanced Parkinson's Disease (PHASE4)
- A Phase 3 Study of Rotigotine in Combination with Rivastigmine in Mild to Moderate Alzheimer's Disease (PHASE3)
- Dopaminergic Therapy for Frontotemporal Dementia Patients (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Neupro CI brief — competitive landscape report
- Neupro updates RSS · CI watch RSS
- UCB portfolio CI