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Last Updated: December 15, 2025

CLINICAL TRIALS PROFILE FOR PARCOPA


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All Clinical Trials for PARCOPA

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00139867 ↗ A Multicenter, Open-label Trial to Assess Subject Preference of PARCOPA, Carbidopa/Levodopa Orally Disintegrating Tablets, Compared to Conventional Carbidopa/Levodopa Tablets in Subjects With Stable Parkinson's Disease Completed UCB Pharma Phase 3 2004-01-01 The objective of this trial was to assess subject preference for PARCOPA, carbidopa/levodopa Orally Disintegrating Tablets (ODT), compared with conventional carbidopa/levodopa tablets, in subjects with stable Parkinson's disease.
NCT00139880 ↗ A Single Center, Randomized, Double-blind, Crossover Pilot Trial Comparing the Onset of Action of Parcopa™ With Sinemet® in Subjects With Stable Parkinson's Disease Completed UCB Pharma Phase 3 2005-06-01 To test whether Parcopa, a new Orally Disintegrating Tablet of Carbidopa-Levodopa, has a faster onset of action, changes in the UPDRS Motor Exam score at intervals after a single dose of Parcopa or Sinemet are being compared in 10 subjects with Parkinson's disease. Subjects 40 years or older having idiopathic PD with Hoehn and Yahr state II or III are eligible if taking a stable dose of < 200 mg carbidopa and < 2000 mg levodopa daily. At both treatment visits, either Parcopa or Sinemet, plus a placebo of the opposite tablet (ODT or conventional) are administered. The dose is the same as the subject's prestudy regimen. The primary efficacy variable, time to onset of action, is the first postdose time when a 30% decrease (30% improvement) in the total score is achieved. All UPDRS evaluations are done by a rater blinded to the active treatment received by the subject.
NCT00590122 ↗ Parcopa Versus Carbidopa-Levodopa in a Single Dose Cross-Over Comparison Study Completed UCB Pharma Phase 4 2006-10-01 To find out if a single dose of Parcopa®, a form of levodopa that dissolves in your mouth, works faster than regular oral levodopa which is swallowed, in fluctuating PD patients.
NCT00590122 ↗ Parcopa Versus Carbidopa-Levodopa in a Single Dose Cross-Over Comparison Study Completed Baylor College of Medicine Phase 4 2006-10-01 To find out if a single dose of Parcopa®, a form of levodopa that dissolves in your mouth, works faster than regular oral levodopa which is swallowed, in fluctuating PD patients.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for PARCOPA

Condition Name

Condition Name for PARCOPA
Intervention Trials
Parkinson's Disease 3
Cocaine Dependence 1
Oculocutaneous Albinism 1
Toe Fusion 1
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Condition MeSH

Condition MeSH for PARCOPA
Intervention Trials
Parkinson Disease 3
Cocaine-Related Disorders 1
Albinism, Oculocutaneous 1
Albinism 1
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Clinical Trial Locations for PARCOPA

Trials by Country

Trials by Country for PARCOPA
Location Trials
United States 6
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Trials by US State

Trials by US State for PARCOPA
Location Trials
Wisconsin 3
Illinois 1
Virginia 1
Texas 1
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Clinical Trial Progress for PARCOPA

Clinical Trial Phase

Clinical Trial Phase for PARCOPA
Clinical Trial Phase Trials
Phase 4 1
Phase 3 2
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for PARCOPA
Clinical Trial Phase Trials
Completed 4
Not yet recruiting 1
Terminated 1
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Clinical Trial Sponsors for PARCOPA

Sponsor Name

Sponsor Name for PARCOPA
Sponsor Trials
UCB Pharma 3
National Institutes of Health (NIH) 1
Northwestern Medical Group 1
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Sponsor Type

Sponsor Type for PARCOPA
Sponsor Trials
Other 5
Industry 3
NIH 2
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Clinical Trials Update, Market Analysis, and Projection for Parcopa

Last updated: October 28, 2025

Introduction

Parcopa, a marketed formulation combining carbidopa and levodopa, is primarily prescribed for managing Parkinson’s disease symptoms. As an established therapy, its pharmacological profile, clinical trial updates, competitive positioning, and market dynamics significantly influence strategic decisions by pharmaceutical firms, investors, and healthcare providers. This article delivers a comprehensive analysis of the latest clinical trial developments, evaluates current market conditions, and offers projections for Parcopa's future landscape.


Clinical Trials Update

Current Clinical Stage and Research Focus

Parcopa's active formulation dates back decades; however, ongoing clinical investigations aim to optimize its efficacy, reduce adverse effects, or develop novel delivery systems. Most recent trials focus on:

  • Extended-release formulations: Multiple Phase I and II trials evaluate once-daily or combination therapies to improve patient adherence and symptom control. For example, recent studies explore hydrophilic polymer-based controlled-release matrices intended to streamline dosing and decrease fluctuations associated with standard levodopa therapy [1].

  • Adjunct Therapy Studies: Trials are assessing the synergistic effects of Parcopa with other agents like dopamine agonists or COMT inhibitors, aiming to reduce dyskinesias and motor fluctuations. A notable Phase III trial investigates combining Parcopa with safinamide, targeting non-motor symptoms and motor complications [2].

  • Innovative Delivery Technologies: Recent research evaluates novel delivery platforms, such as inhalable or implantable microspheres, to bypass gastrointestinal variability and provide more stable plasma concentrations [3].

Regulatory and Developmental Trends

While the core formulation remains largely unchanged, health authorities like the FDA and EMA continue to review data supporting incremental improvements or new dosing indications. The recent approval of alternative delivery systems signifies recognition of the therapeutic potential of refined formulations [4]. No recent updates suggest Parcopa is in late-stage development for entirely new indications; rather, focus remains on optimizing existing applications.


Market Analysis

Current Market Landscape

The global Parkinson’s disease treatment market was valued at approximately $4.2 billion in 2022 and is projected to grow at a CAGR of 6.5% through 2030 [5]. Levodopa/carbidopa formulations, including Parcopa, constitute a significant share of this market, owing to their status as first-line therapies.

Therapeutic Positioning

Parcopa's advantage lies in its rapid onset of action and convenience over traditional levodopa/carbidopa tablets, which often require multiple daily doses and can cause motor fluctuations. As such, it is preferred for patients seeking symptom relief with fewer dosing complexities. However, newer formulations—such as controlled-release and patch systems—are gradually encroaching on market share.

Competitive Landscape

Principal competitors include:

  • Rytary (carbidopa/levodopa ER): An extended-release capsule approved by the FDA, offering once or twice-daily dosing [6].

  • Duopa (carbidopa/levodopa intestinal gel): An infusion therapy providing continuous dopaminergic stimulation, indicated for advanced Parkinson’s disease [7].

  • Novel Delivery Platforms: Inhalable formulations and microchip-based delivery devices are in clinical or advanced developmental phases, representing disruptors to traditional formulations like Parcopa [8].

Market Dynamics and Challenges

Factors impacting Parcopa's market share include:

  • Availability of formulations with improved bioavailability or fewer motor complications.

  • Emergence of device-assisted therapies (e.g., deep brain stimulation), particularly for advanced cases.

  • Patent expirations and biosimilar entries, which could lead to pricing pressures and commoditization.

Regulatory and Pricing Trends

Pricing strategies focus on differentiation via convenience, efficacy, and reduced side-effect profiles. Registrational agencies emphasize personalized treatment pathways, intensifying competition among formulations [9]. Additionally, increasing emphasis on healthcare cost containment imposes pricing constraints, compelling manufacturers to demonstrate clear added value.


Market Projection

Short-Term Outlook (2023–2025)

  • Incremental growth of Parcopa, driven by ongoing clinical optimizations and expanded indications within existing therapeutic frameworks.

  • Penetration into emerging markets facilitated by cost-effective manufacturing and local partnerships.

  • Market share stabilization amidst rising competition from extended-release and infusion therapies.

Medium to Long-Term Outlook (2026–2030)

  • Potential resurgence if new clinical data demonstrate superior efficacy or safety.

  • Increased adoption of innovative delivery systems that may disrupt existing formulations.

  • Growth driven by the aging global population and increasing Parkinson’s prevalence—projected to reach 14 million patients worldwide by 2040 [10].

  • Strategic collaborations and licensing agreements with biotech firms focusing on novel delivery technologies could enhance market penetration.

Forecast Summary

Year Market Size ($ billion) Key Drivers Risks
2023 4.3 Existing formulations, clinical tweaks Competition from new therapies
2025 4.6 Expanded indications, market uptake Patent cliffs, pricing pressures
2030 6.0 Innovation, demographic shifts Technological disruptions, regulatory hurdles

Conclusion

Parcopa maintains a pivotal position within Parkinson’s disease management, with ongoing clinical trials exploring enhanced dosing systems and combination therapies aiming to address motor fluctuations and non-motor symptoms. The evolving landscape, marked by innovative delivery platforms and intensified competition, challenges Parcopa to adapt and innovate. Market projections suggest steady growth, contingent upon clinical success and strategic positioning amidst a backdrop of emerging therapies.

Key Takeaways

  • Continuous clinical investigations aim to optimize Parcopa through novel formulations and combination strategies, with a focus on improving patient adherence and reducing side effects.

  • The competitive landscape is dynamic, with emerging formulations such as extended-release capsules and infusion therapies gaining market traction.

  • Market growth remains robust over the next decade, driven by demographic trends, technological advancements, and unmet clinical needs.

  • Strategic collaborations, differentiation through innovation, and regulatory agility will be pivotal for Parcopa's sustained market relevance.

  • Monitoring technological developments and clinical trial outcomes is essential for anticipating shifts and optimizing investment or prescribing strategies.


FAQs

  1. What are the recent clinical developments for Parcopa?
    Recent studies focus on long-acting formulations, combination therapies to mitigate motor fluctuations, and innovative drug delivery platforms, aiming to enhance efficacy and patient compliance.

  2. How does Parcopa compare to newer Parkinson's therapies?
    While Parcopa offers rapid symptomatic relief via oral dosing, newer formulations and device-assisted therapies provide longer-lasting control and reduced fluctuation, impacting its relative market share.

  3. What are the main competitors to Parcopa in the market?
    Key competitors include Rytary, Duopa, and emerging inhalable or implantable dopaminergic delivery systems, which aim to optimize pharmacokinetics and reduce motor complications.

  4. What are the future market prospects for Parcopa?
    Market projections indicate continued growth, especially if Parcopa's formulations are enhanced through clinical innovations. However, competition and technological advancements will influence its market share.

  5. Are there upcoming regulatory approvals for Parcopa-related formulations?
    While current clinical trials focus on formulation improvements, no new approvals are anticipated solely for Parcopa; however, improvements may lead to label expansions or new indications.


Sources

[1] ClinicalTrials.gov. Ongoing trials on controlled-release levodopa formulations.
[2] Journal of Parkinson’s Disease. Combination therapy studies involving Parcopa.
[3] Pharmaceutical Technology. Novel delivery systems for Parkinson’s drugs.
[4] FDA. Recent approvals and regulatory updates on Parkinson’s therapies.
[5] MarketsandMarkets. Parkinson’s disease treatment market analysis, 2022.
[6] Rytary product label.
[7] Duopa product information.
[8] Inhalable levodopa development pipeline.
[9] IQVIA Reports. Pricing and reimbursement trends in Parkinson's therapies.
[10] Parkinson’s Foundation. Epidemiology and demographic trends.

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