NEUPRO
Neupro (rotigotine) is a non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease and Restless Legs Syndrome. The medication is used for patients diagnosed with Parkinson's disease or those experiencing moderate-to-severe primary Restless Legs Syndrome. It serves as a therapeutic option for managing the symptoms of these neurological disorders.
How NEUPRO Works
Rotigotine functions as a non-ergoline dopamine agonist that works by stimulating dopamine receptors. In the treatment of Parkinson’s disease, this activity is thought to occur specifically within the caudate-putamen region of the brain. For Restless Legs Syndrome, the therapeutic effect is similarly attributed to the drug's ability to activate dopamine receptors.
Details
- Status
- Prescription
- First Approved
- 2007-05-09
- Routes
- TRANSDERMAL
- Dosage Forms
- FILM, EXTENDED RELEASE
NEUPRO Approval History
What NEUPRO Treats
2 indicationsNEUPRO is approved for 2 conditions since its original approval in 2007. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Parkinson's Disease
- Restless Legs Syndrome
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
NEUPRO FDA Label Details
ProIndications & Usage
FDA Label (PDF)NEUPRO is a dopamine agonist indicated for the treatment of: Parkinson's disease Moderate-to-severe primary Restless Legs Syndrome 1.1 Parkinson's Disease (PD) NEUPRO is indicated for the treatment of Parkinson's disease. 1.2 Restless Legs Syndrome (RLS) NEUPRO is indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome.
NEUPRO Patents & Exclusivity
Patents (180 active)
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.