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Last Updated: May 18, 2025

CLINICAL TRIALS PROFILE FOR NEUPRO


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All Clinical Trials for Neupro

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00292227 ↗ Cardiac Effects of Rotigotine Transdermal System in Subjects With Advanced-stage Idiopathic Parkinson's Disease Completed UCB Pharma Phase 1 2006-01-01 The purpose of this trial is to assess whether rotigotine has an effect on the electrical activity of the heart. Moxifloxacin infusion is used as positive control to assess assay sensitivity.
NCT00296192 ↗ Efficacy, Safety and Tolerability of Rotigotine Nasal Spray for the Acute Treatment of Parkinson Symptoms Completed UCB Pharma Phase 2 2006-02-01 The objective of this trial is to evaluate safety and efficacy of rotigotine nasal spray (SPM 952) in a single dose application scheme. Subjects will undergo a 2 - 28 days screening period in which eligibility criteria will be checked. Subjects will then be hospitalized for one night. In the morning of the next day, subjects will be randomly assigned either to rotigotine or placebo nasal spray and will then receive a single dose of trial medication. Safety assessments after application include adverse events, 12-lead electrocardiograms, blood pressure and heart rate assessments, and laboratory checks. Efficacy will be assessed by application of motor examination scores. The first subject is planned to be enrolled in February 2006. The last subject is planned to be enrolled in May 2006. Last subject out is expected for August 2006.
NCT00464737 ↗ The Use of Rotigotine for Treatment of Reducing Signs and Symptoms of Fibromyalgia in Adults. Completed UCB Pharma Phase 2 2007-03-01 This trial is to investigate the efficacy and safety of rotigotine as compared to placebo in reducing signs and symptoms of fibromyalgia syndrome. The effects of rotigotine on pain, sleep, general activity, mood, and quality of life, and the use of rescue medication to treat pain will be assessed.
NCT00474058 ↗ Randomized Evaluation of the 24-Hour Coverage: Efficacy of Rotigotine Completed UCB Pharma Phase 3 2007-05-01 The objective of this trial is to assess the effects of transdermal rotigotine on the control of early morning motor function and sleep disorders compared to placebo in subjects with idiopathic Parkinsons´s disease. In addition, effects of rotigotine on specific nocturnal and non-motor symptoms of Parkinson´s disease will be evaluated.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Neupro

Condition Name

Condition Name for Neupro
Intervention Trials
Parkinson's Disease 13
Restless Legs Syndrome 5
Parkinson Disease 4
Healthy 3
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Condition MeSH

Condition MeSH for Neupro
Intervention Trials
Parkinson Disease 23
Syndrome 7
Restless Legs Syndrome 6
Psychomotor Agitation 6
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Clinical Trial Locations for Neupro

Trials by Country

Trials by Country for Neupro
Location Trials
United States 144
Germany 12
Canada 9
Italy 9
India 7
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Trials by US State

Trials by US State for Neupro
Location Trials
Florida 12
California 10
Texas 8
North Carolina 7
New York 7
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Clinical Trial Progress for Neupro

Clinical Trial Phase

Clinical Trial Phase for Neupro
Clinical Trial Phase Trials
Phase 4 6
Phase 3 11
Phase 2 7
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Clinical Trial Status

Clinical Trial Status for Neupro
Clinical Trial Phase Trials
Completed 31
Terminated 2
Unknown status 2
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Clinical Trial Sponsors for Neupro

Sponsor Name

Sponsor Name for Neupro
Sponsor Trials
UCB Pharma 17
UCB BIOSCIENCES GmbH 7
Luye Pharma Group Ltd. 4
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Sponsor Type

Sponsor Type for Neupro
Sponsor Trials
Industry 35
Other 15
NIH 2
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NEUPRO: Clinical Trials, Market Analysis, and Projections

Overview of NEUPRO

NEUPRO, also known as rotigotine, is a non-ergot dopamine agonist formulated as an extended-release transdermal patch. It is indicated for the treatment of Parkinson’s disease (PD) and restless legs syndrome (RLS)[2].

Clinical Trials Update

Efficacy in Parkinson’s Disease

Clinical trials have shown that NEUPRO is effective in treating both early-stage and advanced Parkinson’s disease. In early-stage disease, 48 to 52% of patients using NEUPRO experienced an improvement in symptoms, compared to 19 to 30% of those using placebo. However, NEUPRO was less effective than ropinirole, with 70% of patients receiving ropinirole showing improvement. In advanced disease, NEUPRO reduced the 'off' time (periods when Parkinson’s symptoms are not well-controlled) by 2.1 to 2.7 hours, similar to the reduction seen with pramipexole[1].

Efficacy in Restless Legs Syndrome

In moderate to severe restless legs syndrome, NEUPRO demonstrated significant improvement in symptoms compared to placebo. Patients using doses of NEUPRO between 1 and 3 mg/24 hours showed greater improvement in symptoms as measured by standard symptom scales[1].

Ongoing and Future Trials

A recent clinical trial is underway to investigate the patch adhesion properties of a newly developed rotigotine patch compared to the marketed NEUPRO patch. This multi-center, open, randomized trial aims to assess the adhesion of the patches after multiple applications[4].

Market Analysis

Market Indications and Usage

NEUPRO is approved for use in any stage of Parkinson’s disease and for moderate-to-severe restless legs syndrome, making it a versatile treatment option in the neurology market[2].

Competitive Landscape

The Parkinson’s disease market is highly competitive, with NEUPRO competing against other dopamine agonists such as pramipexole and ropinirole. Despite its unique transdermal delivery system, NEUPRO faces significant challenges from generic versions of these competitors, which can impact its market share and pricing[2].

Financial Performance

NEUPRO has experienced declining net sales in several key markets, including the U.S. and Japan, due to the competitive market environment and the impact of generic erosion. While UCB reported stable net sales for NEUPRO in Europe, the decline in other markets has been a significant concern. The cost of NEUPRO is generally higher compared to its generic competitors, which further affects its market position[2].

Market Projections

Parkinson’s Disease Market Growth

The Parkinson’s disease market is expected to grow at a Compound Annual Growth Rate (CAGR) of 5.8% from 2020 to 2034. This growth is driven by advancements in diagnostic techniques, increased awareness of the condition, and a robust emerging pipeline of late-stage drugs[5].

Impact of Emerging Therapies

The approval of new therapies such as Supernus Pharmaceuticals/Britannia Pharmaceuticals' SPN-830, AbbVie's tavapadon, and Pharma Two B's P2B001 could significantly impact the market dynamics. These new treatments may offer alternative options for patients, potentially affecting NEUPRO’s market share. For instance, tavapadon, a first-in-class D1/D5 partial agonist, has shown significant improvement in motor function in clinical trials and is expected to be submitted for FDA approval in 2025[5].

Financial Modeling and Valuation

Net Present Value (NPV) Model

Evaluating the financial trajectory of NEUPRO involves complex financial modeling, including NPV analysis. The NPV model considers factors such as revenue and cost forecasts, patent law, regulatory approvals, and cash flows to derive the NPV of the drug. This model helps in understanding the expected profitability and cash flow generation from NEUPRO over a forecast period[2].

Operating Profit and Cash Flow

The NPV model includes a forecasted revenue model, operating profit model, net profit calculation, and discounted cash flow analysis. These components are crucial for understanding the financial health and future prospects of NEUPRO[2].

Challenges and Opportunities

Generic Erosion

One of the significant challenges facing NEUPRO is generic erosion, particularly in markets like the U.S. and Japan. Generic versions of competing drugs can significantly reduce the market share and pricing power of NEUPRO[2].

Regulatory and Market Approval

NEUPRO has faced regulatory challenges in the past, such as its temporary withdrawal from the U.S. market due to issues with crystallization in the patch. Ensuring regulatory compliance and maintaining market approval is crucial for its continued success[2].

Pipeline Development

While NEUPRO is not currently under development for new indications, its manufacturer, UCB, is actively involved in developing other innovative therapies. This pipeline activity can help mitigate the impact of declining sales of NEUPRO by offering new revenue streams[2].

Key Takeaways

  • Market Indications: NEUPRO is approved for Parkinson’s disease and restless legs syndrome, offering a broad range of treatment options.
  • Competitive Landscape: Faces competition from generic dopamine agonists, impacting its market share and pricing.
  • Financial Performance: Experiencing declining net sales in key markets due to generic erosion and competitive pressures.
  • Market Growth: The Parkinson’s disease market is expected to grow, but new therapies may impact NEUPRO’s market share.
  • Financial Modeling: NPV models are essential for evaluating the financial trajectory and valuation of NEUPRO.

FAQs

What is NEUPRO used for?

NEUPRO is used for the treatment of Parkinson’s disease and restless legs syndrome. It is approved for use in any stage of Parkinson’s disease and for moderate-to-severe restless legs syndrome[2].

How does NEUPRO work?

NEUPRO works by delivering a constant supply of rotigotine, a dopamine agonist, through the skin into the bloodstream. Rotigotine stimulates the brain as dopamine would, helping patients control their movements and reduce symptoms of Parkinson’s disease and restless legs syndrome[1].

What are the common side effects of NEUPRO?

Common side effects include application site reactions, nausea, disturbances in initiating and maintaining sleep, somnolence, and headache. Patients may also experience intense urges to gamble, increased sexual urges, and other behavioral changes[3].

How does NEUPRO compare to other dopamine agonists?

NEUPRO has been compared to other dopamine agonists like ropinirole and pramipexole in clinical trials. While it is effective, it was found to be less effective than ropinirole in early-stage Parkinson’s disease but comparable in advanced disease[1].

What is the outlook for NEUPRO in the market?

The Parkinson’s disease market is expected to grow, but NEUPRO faces challenges from emerging therapies and generic competition. Its market share and pricing are likely to be impacted by these factors[2][5].

Sources

  1. European Medicines Agency (EMA). Neupro | European Medicines Agency (EMA).
  2. Drug Patent Watch. NEUPRO Drug Patent Profile.
  3. NEUPRO Official Website. Why NEUPRO may be right for you.
  4. ClinicalTrials.gov. Clinical Trial to Investigate Patch Adhesion of Rotigotine Containing Patches in Patients with Parkinson’s Disease.
  5. GlobeNewswire. Parkinson's Disease Market is Expected to Showcase a Significant Growth at a CAGR of 5.8% During the Study Period (2020–2034) | DelveInsight.
Last updated: 2024-12-31

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