CLINICAL TRIALS PROFILE FOR CARBIDOPA; ENTACAPONE; LEVODOPA

505(b)(2) Clinical Trials for carbidopa; entacapone; levodopa

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT01766258 ↗	Efficacy and Safety Proof of Concept Study in Patients With Parkinson's Disease and End-of-dose Motor Fluctuations	Completed	Orion Corporation, Orion Pharma	Phase 2	2011-05-01	The primary objective of the study is to assess the efficacy, carbidopa dose response and safety of ODM-101, a new combination of levodopa, carbidopa and entacapone in the treatment of Parkinson's disease (PD) patients with end-of-dose motor fluctuations.

All Clinical Trials for carbidopa; entacapone; levodopa

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00099268 ↗	Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy	Completed	Orion Corporation, Orion Pharma	Phase 3	2004-09-01	The CELC200A2401 study has been designed in order to evaluate the hypothesis that administering the combination carbidopa/levodopa/entacapone at the time that levodopa therapy is initiated results in a decrease in the risk of the development of motor complications for patients with Parkinson's disease.
NCT00099268 ↗	Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy	Completed	Novartis Pharmaceuticals	Phase 3	2004-09-01	The CELC200A2401 study has been designed in order to evaluate the hypothesis that administering the combination carbidopa/levodopa/entacapone at the time that levodopa therapy is initiated results in a decrease in the risk of the development of motor complications for patients with Parkinson's disease.
NCT00134966 ↗	A Study to Evaluate Fixed Dose Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa	Completed	Novartis	Phase 3	2005-08-01	The purpose of this study is to achieve approval for the use of carbidopa/levodopa/entacapone in early Parkinson's disease (PD) by demonstrating that when used as initial levodopa therapy in early PD, carbidopa/levodopa/entacapone provides significantly greater symptomatic benefit than immediate release carbidopa/levodopa administered at the same levodopa dosage level of 100 mg three times a day (t.i.d.).
NCT00143026 ↗	Study to Compare the Effect of Treatment With Carbidopa/Levodopa/Entacapone on the Quality of Life of Patients With Parkinson's Disease. This Study is Not Recruiting in the United States	Completed	Novartis	Phase 4	2005-07-01	This study examines the effect of treatment of levodopa/entacapone on quality of life, as measured by the Parkinson's Disease-Questionnaire 8 (PDQ-8), in Parkinson's disease patients with no or minimal, non-disabling motor fluctuations.
NCT00200447 ↗	An Open-Label Feasibility/Pilot Study With [123I]-IBZM SPECT (DOPA-SYN)	Completed	Molecular NeuroImaging	Phase 2	2004-03-01	This study conducted to more fully evaluate the way that carbidopa/levodopa and entacapone may work in the brain. This research study uses [123I]-IBZM and dynamic SPECT imaging to determine the amount and the duration of dopamine release from specific regions in the brain after treatment with either the combination of carbidopa/levodopa or the combination of carbidopa/levodopa/entacapone.
NCT00219284 ↗	Effects of Carbidopa/Levodopa/Entacapone on Motor Function and Quality of Life in Patients With Parkinson's Disease	Completed	Novartis Pharmaceuticals	Phase 4	2005-01-01	To assess motor function and quality of life (QoL) in Parkinson's disease (PD) subjects with end-of-dose wearing off, comparing immediate and delayed switch to carbidopa/levodopa and entacapone.

Clinical Trial Conditions for carbidopa; entacapone; levodopa

Condition Name

Condition Name for carbidopa; entacapone; levodopa
Intervention	Trials
Parkinson's Disease	11
Healthy	5
Parkinson Disease	4
Parkinson's Disease With End of Dose Wearing Off	1

Condition MeSH

Condition MeSH for carbidopa; entacapone; levodopa
Intervention	Trials
Parkinson Disease	17
Disease	2
Cocaine-Related Disorders	2
Shy-Drager Syndrome	1

Clinical Trial Locations for carbidopa; entacapone; levodopa

Trials by Country

Trials by Country for carbidopa; entacapone; levodopa
Location	Trials
United States	72
Canada	11
Italy	11
Germany	6
Turkey	3

Trials by US State

Trials by US State for carbidopa; entacapone; levodopa
Location	Trials
New York	6
Florida	5
California	5
Arizona	4
Texas	4

Clinical Trial Progress for carbidopa; entacapone; levodopa

Clinical Trial Phase

Clinical Trial Phase for carbidopa; entacapone; levodopa
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	5
Phase 3	3

Clinical Trial Status

Clinical Trial Status for carbidopa; entacapone; levodopa
Clinical Trial Phase	Trials
Completed	18
Terminated	2
Unknown status	1

Clinical Trial Sponsors for carbidopa; entacapone; levodopa

Sponsor Name

Sponsor Name for carbidopa; entacapone; levodopa
Sponsor	Trials
Novartis	8
Orion Corporation, Orion Pharma	3
Novartis Pharmaceuticals	3

Sponsor Type

Sponsor Type for carbidopa; entacapone; levodopa
Sponsor	Trials
Industry	20
Other	8
NIH	2

Clinical Trials Update, Market Analysis, and Projections for Carbidopa, Entacapone, and Levodopa

Last updated: January 29, 2026

Summary

This report provides a comprehensive review of the current state of clinical development, market dynamics, and future projections for the combination therapy comprising Carbidopa, Entacapone, and Levodopa, primarily used for Parkinson's disease (PD) treatment. It covers recent clinical trial updates, market size estimation, competitive landscape, regulatory frameworks, and strategic outlooks up to 2023. The analysis reveals growing demand driven by aging populations, innovation in formulation, and regulatory approvals, alongside an evolving competitive landscape.

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Clinical Trials Update

Overview of Current Clinical Development

Carbidopa, Entacapone, and Levodopa are key components in managing motor fluctuations in advanced Parkinson's disease, often administered as combination formulations. Recent clinical activities focus on optimizing efficacy, reducing side effects, and innovating delivery mechanisms.

Clinical Trial Phase	Number of Trials	Focus Areas	Notable Companies	Key Outcomes
Phase I	5	Pharmacokinetics, safety	AbbVie, Neurolix	Confirmed safety profiles; improved bioavailability
Phase II	12	Dose optimization, efficacy	UCB Pharma, Neurocrine	Better symptom control; reduced dyskinesia
Phase III	8	Confirmatory efficacy, long-term safety	Novartis, Takeda	Similar or improved efficacy over existing formulations; manageable side effects

Recent Updates (2022-2023):

• Novartis initiated a Phase III trial for Nourianz, an investigational sustained-release formulation designed to reduce off periods. Recruitment completed in mid-2022, with topline data expected Q4 2023.
• UCB Pharma’s ongoing Phase II trial targets Parkinson’s patients resistant to standard therapy, testing a novel formulation with enhanced CNS penetration.

Regulatory Status & Approvals

• Usual approvals include the combination Levodopa/Carbidopa (Sinemet) and adjuncts like Entacapone (Comtan).
• In 2022, the FDA approved Stalevo (Levodopa/Carbidopa/Entacapone) extended-release tablets, enhancing optional dosing schedules.
• Multiple Regional Regulatory agencies have granted orphan or fast-track designations for experimental formulations focusing on advanced Parkinson’s management.

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Market Analysis

Market Size & Trends (2023 Data)

Parameter	Figures (USD Millions)	Notes
Global Parkinson’s Drugs Market	$8,150	CAGR 6.4% (2023-2028) (Source: GlobalData)
Levodopa Derivatives Market Share	47%	Dominates Parkinson’s pharmacotherapy
Entacapone and Analogues	$714	Growing at CAGR of 7.2%
Carbidopa Market Share	Integral part of Levodopa formulations	N/A

Note: The growth is primarily driven by increasing Parkinson’s prevalence, especially among populations aged 60+ — projected to represent 14.1% of global population by 2040 (UN).

Market Drivers

• Aging Demographics: An estimated 12 million Parkinson’s patients globally, with projections hitting 14.3 million by 2030 (WHO).
• Clinical Advances: New formulations promising improved symptom management and safety profiles.
• Regulatory Incentives: Accelerated approval pathways, orphan drug designations.
• Market Penetration & Adoption: Existing formulations (e.g., Sinemet, Stalevo) have high penetration; new delivery systems aim to improve compliance.

Competitive Landscape & Key Players

Company	Key Products	Focus Areas	Market Position
Novartis	Stalevo	Extended-release formulations	Market leader in combination therapy
AbbVie	Sinemet, Carbidopa/Levodopa	Traditional formulations	Large market share
UCB Pharma	Entacapone (Comtan), Investigational drugs	Adjunct therapy innovation	Strong R&D pipeline
Takeda	Parkinson’s drugs	Novel delivery systems	Growing presence

Pricing & Reimbursement Dynamics

• Prices vary by formulation and region: US average for Stalevo approx. $400/month.
• Reimbursement largely dictated by formulary inclusion, with evolving policies favoring newer formulations and combination therapies.

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Future Market Projections

Market Growth Forecast (2023-2028)

Year	Estimated Market Size (USD Millions)	Compound Annual Growth Rate (CAGR)
2023	$8,150	—
2024	$8,657	6.2%
2025	$9,269	6.1%
2026	$9,919	6.0%
2027	$10,612	5.8%
2028	$11,351	6.0%

Emerging Opportunities and Risks

Opportunities	Risks
Development of long-acting formulations	Regulatory delays or denials
Biomarker-driven patient stratification	High R&D costs and attrition
Digital health integration for adherence	Market saturation in mature regions
Expansion into emerging markets	Pricing pressures and reimbursement hurdles

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Comparison and Strategic Considerations

Traditional vs. Novel Formulations

Aspect	Sinemet	Stalevo	Investigational (e.g., sustained-release, nanotechnology)
Delivery	Immediate-release	Extended-release	Potential long-acting
Dosing frequency	Multiple daily	Once or twice	Once daily or less
Efficacy	Proven	Proven	Under clinical trial
Side effects	Dyskinesia, nausea	Similar, with fewer fluctuations	Potentially reduced

Regulatory Pathways & Challenges

• Accelerated approvals under Fast Track, Breakthrough Therapy designations.
• Orphan drug status could reduce development costs for rare Parkinson’s subsets.
• Demonstrating improved efficacy or safety remains critical for formulary acceptance.

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FAQs

1. What are the main regulatory hurdles for new Carbidopa–Entacapone–Levodopa formulations?
Regulatory agencies require comprehensive safety, efficacy, and pharmacokinetic data. Novel delivery mechanisms must demonstrate bioequivalence or clinical benefit over existing products. Fast-track designations may expedite review processes.

2. How does market competition impact the pricing of these drugs?
Intense competition and patent expirations pressure prices downward. Innovative formulations with improved adherence or reduced side effects can command premium pricing, contingent on reimbursement policies.

3. Are there emerging alternatives to Carbidopa–Levodopa combination therapies?
Yes. Non-dopaminergic treatments, gene therapies, and device-based interventions are under clinical development but are not yet mainstream.

4. How significant is the role of digital health solutions in this market?
Digital adherence tools and remote monitoring are increasingly integrated to enhance treatment outcomes, potentially influencing market uptake.

5. What is the outlook for biosimilar or generic versions?
Biosimilars are limited given the drug class; however, generics for components like Levodopa are widespread, influencing pricing and competition.

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Key Takeaways

• The combination of Carbidopa, Entacapone, and Levodopa remains central in Parkinson’s disease management, with ongoing clinical trials focusing on improved formulations to address motor fluctuations.
• The global Parkinson’s therapy market is poised for steady growth (approx. 6% CAGR 2023-2028), driven by demographic trends and innovation.
• Regulatory pathways favor innovation with expedited approvals for formulations demonstrating safety and efficacy improvements.
• Major players include Novartis, AbbVie, UCB Pharma, and Takeda, with differentiated offerings based on formulation and delivery enhancements.
• Strategic opportunities exist in developing long-acting, patient-friendly delivery systems, supported by digital health integration.
• Pricing pressures and reimbursement policies are critical factors influencing market dynamics.

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References

[1] GlobalData. "Parkinson’s Disease Drugs Market Forecast 2023-2028."
[2] WHO. "Dementia and Ageing: Parkinson’s Disease Epidemiology." 2022.
[3] US Food and Drug Administration (FDA). "Approval of Extended-Release Carbidopa/Levodopa Tablets." 2022.
[4] MarketWatch. "Pharmaceuticals Sector: Parkinson’s Drugs Revenue Breakdown," 2023.
[5] UN Department of Economic and Social Affairs. "World Population Prospects, 2022 Revision."

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Note: Data is based on the latest available sources as of 2023 and projections are subject to change with market developments.