NEUPRO (rotigotine)
NEUPRO is indicated for the treatment of Parkinson's Disease; Restless Legs Syndrome.
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.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2007-05-09
- Patent Cliff
- 2032
- 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
NEUPRO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to NEUPRO
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
21 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03103919 results posted | PD0049 | Ph 4 | completed | Study to Evaluate the Impact of Using Wearable Devices in Addition to Standard Clinical Practice on Parkinson´s Subject Symptoms Management |
| NCT01782222 BRIGHT results posted | PD0005 2012-002840-26 | Ph 4 | completed | Trial to Evaluate The Efficacy Of Rotigotine on Parkinson's Disease-Associated Motor Symptoms And Apathy |
| NCT01823770 | 8917 | Ph 4 | completed | Effect of Rotigotine Patch Treatment on Cardiovascular Markers in Idiopathic Restless Legs Syndrome |
| NCT01495793 results posted | SP1004 2014-004383-37 | Ph 2 | completed | Dose Escalating Study of Rotigotine in Pediatric Subjects With Restless Legs Syndrome |
| NCT01646255 results posted | SP1037 | Ph 3 | completed | Rotigotine Versus Placebo, A Study To Evaluate The Efficacy In Advanced Stage Idiopathic Parkinson's Disease Patients |
| NCT01498120 results posted | SP1005 | Ph 2 | completed | Long-Term Follow-Up Study for Safety, Efficacy and Tolerability of Rotigotine in Adolescents With Restless Legs Syndrome |
| NCT02728947 | LY03003-CT-USA-103 | Ph 1 | completed | Pharmacokinetic Profile of Neupro Patch Administrated at 2 mg, 4 mg, 6 mg and 8 mg/Day Weekly in Patients With Early-stage Parkinson's Disease |
| NCT01976871 SWITCH results posted | MGH - 2013P000968 | Ph 4 | completed | Switching From Oral Dopamine Agonists to Rotigotine |
| NCT02103465 PARROT | EudraCT Number: 2013-000827-15 | Ph 2 | terminated | Possible Use of Rotigotine in Subjects 70 Years and Older With Late Onset of Disease |
| NCT01523301 results posted | SP1041 | Ph 4 | completed | Rotigotine Versus Placebo to Evaluate the Efficacy on Depressive Symptoms in Idiopathic Parkinson's Disease Patients |
| NCT02055274 03003MAD | LY03003 | Ph 1 | completed | Pharmacokinetics and Safety Study of LY03003 in Patients With Early-stage Parkinson's Disease |
| NCT01646268 results posted | SP0914 | Ph 3 | completed | Rotigotine Versus Placebo As Double Blind Study To Evaluate The Efficacy In Early Stage Idiopathic Parkinson's Disease Patients |
| NCT01744496 DOLORES results posted | PD0004 2012-002608-42 | Ph 4 | completed | Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain |
| NCT01537042 results posted | SP0934 2011-003486-15 | Ph 3 | completed | A Sleep Laboratory Study to Investigate the Safety and Efficacy of the Rotigotine Skin Patch in Subjects With Restless Legs Syndrome and End-Stage Renal Disease Requiring Hemodialysis |
| NCT01569464 RESTORE results posted | RL0003 | Ph 3 | completed | Rotigotine Effect on All-day Functioning and Quality of Life in Subjects With Moderate to Severe Restless Legs Syndrome (RLS) |
| NCT01536015 ROADMAP results posted | SP1055 | Ph 3 | terminated | Effect of Rotigotine on Motor Symptoms in Patients With Advanced Parkinson's Disease (PD) With Motor Fluctuations and Symptoms of Gastrointestinal Dysfunction |
| NCT01723904 results posted | PD0015 | Ph 3 | completed | A Phase 3b, Open-Label, Safety and Efficacy Study of Rotigotine as Add-On Therapy With Low Doses of Pramipexole or Ropinirole in Patients With Advanced Parkinson's Disease |
| NCT01300819 results posted | SP0976 2010-021394-37 | Ph 4 | completed | Placebo-controlled Study in Patients With Parkinson's Disease to Evaluate the Effect of Rotigotine on Non-motor Symptoms |
| NCT01711866 results posted | PD0009 | Ph 4 | completed | A Phase 4, Open-label Study to Assess the Feasibility and Efficacy on Motor and Non-motor Symptoms of Switching From Pramipexole or Ropinirole to Rotigotine Transdermal Patch in Subjects With Advanced Idiopathic Parkinson's Disease |
| NCT01455012 ENCORE results posted | SP0977 2011-000053-23 | Ph 4 | completed | Effects of Neupro on Cardiovascular Observations in Patients With Restless Legs Syndrome |
| NCT00663338 | BRD/06/162 MRC77096 | Ph 2 | completed | Dopamine Agonist for Hemispatial Neglect and Motor Deficit Post Stroke |
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
Indications & Usage
FDA Label (PDF)NEUPRO is indicated for the treatment of Parkinson's Disease; Restless Legs Syndrome.
NEUPRO Patents & Exclusivity
Patents (4 active)
Pro Intelligence Preview
Deep insights for NEUPRO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2032
- • 180 active patents
Trial Analysis
- • 21 total trials
- • Stage: Mature
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment