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Last Updated: July 14, 2025

CLINICAL TRIALS PROFILE FOR CARBIDOPA; ENTACAPONE; LEVODOPA


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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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

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.).
>Trial ID >Title >Status >Phase >Start Date >Summary

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 3
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Condition MeSH

Condition MeSH for Carbidopa; Entacapone; Levodopa
Intervention Trials
Parkinson Disease 16
Cocaine-Related Disorders 2
Disease 2
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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
Czechia 3
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Trials by US State

Trials by US State for Carbidopa; Entacapone; Levodopa
Location Trials
New York 6
Florida 5
California 5
Texas 4
Pennsylvania 4
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Clinical Trial Progress for Carbidopa; Entacapone; Levodopa

Clinical Trial Phase

Clinical Trial Phase for Carbidopa; Entacapone; Levodopa
Clinical Trial Phase Trials
Phase 4 5
Phase 3 3
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Carbidopa; Entacapone; Levodopa
Clinical Trial Phase Trials
Completed 18
Terminated 2
Unknown status 1
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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
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Sponsor Type

Sponsor Type for Carbidopa; Entacapone; Levodopa
Sponsor Trials
Industry 20
Other 7
NIH 2
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Carbidopa, Entacapone, and Levodopa: Clinical Trials, Market Analysis, and Projections

Last updated: January 1, 2025

Introduction

The combination of carbidopa, entacapone, and levodopa is a crucial treatment for managing Parkinson's disease, a progressive neurological disorder characterized by the loss of dopamine-producing neurons in the brain. This article delves into the current clinical trials, market analysis, and future projections for this drug combination.

Clinical Trials and Optimization Strategies

Current Trials and Studies

Recent clinical trials have focused on optimizing levodopa therapy to minimize motor complications and improve patient outcomes. The PDMed Trial, for example, randomized newly diagnosed Parkinson's disease patients to either levodopa-sparing therapies or levodopa monotherapy. The study found that initiating treatment with levodopa had initial benefits and no long-term disadvantages compared to levodopa-sparing therapies[3].

Another significant study, the PRADO study, evaluated the effects of levodopa monotherapy versus levodopa combined with bromocriptine on the development of motor complications. The results indicated that early combination therapy can extend the period of optimal disease control[3].

Optimization Strategies

Optimizing levodopa therapy involves combining levodopa with adjuvant treatments such as MAO-B inhibitors, COMT inhibitors, and dopamine agonists. This approach helps reduce motor complications that develop with sustained levodopa therapy. For instance, adding entacapone, a COMT inhibitor, blocks the enzyme catechol-O-methyl transferase (COMT), allowing levodopa to remain active for longer periods[5].

Market Analysis

Global Market Size and Growth

The global levodopa market, which includes combinations with carbidopa and entacapone, was valued at $1.7 billion in 2022 and is projected to reach $2.9 billion by 2032, growing at a CAGR of 6.1% from 2023 to 2032. This growth is driven by the increasing prevalence of Parkinson's disease, particularly among the aging population[2].

Regional Market Dynamics

North America dominates the global levodopa market due to its robust healthcare infrastructure, advanced medical research facilities, and high prevalence of Parkinson's disease. The region's supportive healthcare policies and reimbursement frameworks also contribute to the market's growth[2].

Key Market Players

Major players in the levodopa market include Novartis AG, Merck & Co. Inc., Eli Lilly & Company, Bristol-Myers Squibb Co., Teva Pharmaceutical Industries Ltd., Impax Laboratories Inc., Pfizer Inc., UCB SA, Sun Pharmaceutical Industries Ltd., and Mylan NV. These companies are investing in research and development to enhance treatment efficacy and accessibility[2].

Funding and Accessibility

Recent Funding Decisions

In a significant development, Pharmac in New Zealand has announced the funding of levodopa with carbidopa and entacapone combination tablets (branded as Stalevo) from 1 February 2025. This decision is expected to benefit around 580 people in the first year, increasing to 700 after five years. The funding includes four different strengths of combination tablets, simplifying treatment regimens for patients[1].

Impact on Patient Care

The combination of levodopa, carbidopa, and entacapone in a single tablet improves patient compliance by reducing the number of tablets patients need to take. This formulation also enhances the therapeutic effect by prolonging the activity of levodopa in the body[5].

Future Projections

Technological Advancements

Advancements in drug delivery systems, such as the introduction of levodopa–entacapone–carbidopa intestinal gel (LECIG), are expected to further improve treatment outcomes. LECIG, introduced in Sweden in 2019, is aimed at patients with advanced Parkinson's disease and offers continuous drug delivery, reducing motor fluctuations[4].

Emerging Markets

The Asia-Pacific region is projected to provide significant business opportunities for the levodopa market in the future. The growing aging population and increasing healthcare expenditure in this region are expected to drive the demand for effective Parkinson's disease treatments[2].

Personalized Medicine

There is an increasing focus on personalized medicine, which involves tailoring treatment strategies to individual patient needs. This approach is likely to enhance treatment efficacy and patient outcomes, driving further growth in the levodopa market[2].

Key Takeaways

  • The global levodopa market is expected to grow significantly due to the rising prevalence of Parkinson's disease.
  • Combination therapies involving levodopa, carbidopa, and entacapone are becoming more prevalent and are supported by clinical trials.
  • Recent funding decisions, such as the one in New Zealand, are improving accessibility to these treatments.
  • Technological advancements and emerging markets are expected to drive future growth.
  • Personalized medicine approaches are likely to enhance treatment outcomes.

FAQs

What is the primary use of levodopa in medical treatment?

Levodopa is primarily used to manage symptoms of Parkinson's disease by replenishing deficient dopamine levels in the brain.

How does the combination of carbidopa and entacapone enhance levodopa therapy?

Carbidopa blocks the enzyme dopa decarboxylase, and entacapone blocks the enzyme catechol-O-methyl transferase (COMT), allowing levodopa to remain active for longer periods and improving the symptoms of Parkinson’s disease[5].

What are the projected market growth and size for the levodopa market by 2032?

The global levodopa market is projected to reach $2.9 billion by 2032, growing at a CAGR of 6.1% from 2023 to 2032[2].

Which regions are expected to drive the growth of the levodopa market in the future?

North America currently dominates the market, but the Asia-Pacific region is projected to provide more business opportunities in the future due to its growing aging population and increasing healthcare expenditure[2].

What are some of the key players in the levodopa market?

Major players include Novartis AG, Merck & Co. Inc., Eli Lilly & Company, Bristol-Myers Squibb Co., Teva Pharmaceutical Industries Ltd., and others[2].

Sources

  1. Pharmac: Decision to fund levodopa with carbidopa and entacapone combination tablets for people with Parkinson’s disease. Retrieved from https://pharmac.govt.nz/news-and-resources/consultations-and-decisions/2024-09-decision-to-fund-levodopa-with-carbidopa-and-entacapone-combination-tablets-for-people-with-parkinson-disease
  2. Allied Market Research: Levodopa Market Size, Growth Analysis | Forecast - 2032. Retrieved from https://www.alliedmarketresearch.com/levodopa-market-A213646
  3. Taylor & Francis Online: Optimizing levodopa therapy, when and how? Perspectives on the current evidence. Retrieved from https://www.tandfonline.com/doi/full/10.1080/14737175.2023.2176220
  4. Synapse: Carbidopa/Levodopa - Drug Targets, Indications, Patents. Retrieved from https://synapse.patsnap.com/drug/53fe95b2d55240a599bd46db2566b529
  5. European Medicines Agency: Levodopa/Carbidopa/Entacapone Orion. Retrieved from https://www.ema.europa.eu/en/medicines/human/EPAR/levodopa-carbidopa-entacapone-orion

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