CLINICAL TRIALS PROFILE FOR ENTACAPONE

505(b)(2) Clinical Trials for ENTACAPONE

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 ENTACAPONE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00044083 ↗	Clinical Trial of Tolcapone for Cognition in Schizophrenia	Terminated	National Institute of Mental Health (NIMH)	Phase 2	2002-08-01	This study will evaluate whether Tolcapone improves cognition in healthy volunteers as well as patients with schizophrenia. Talcapone is a drug that has been FDA approved for Attention Deficit Disorder and allegedly increase the amount of the neurotransmitter dopamine in the frontal cortex of the brain. ...
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.
NCT00192855 ↗	Entacapone Augmentation for Schizophrenia	Completed	Rambam Health Care Campus	N/A	2003-06-01	This study is testing the hypothesis that Entacapone added to ongoing antipsychotic treatment can be beneficial in schizophrenic patients with negative symptoms.

Clinical Trial Conditions for ENTACAPONE

Condition Name

Condition Name for ENTACAPONE
Intervention	Trials
Parkinson's Disease	17
Parkinson Disease	7
Healthy	7
Parkinson's Disease (PD)	2

Condition MeSH

Condition MeSH for ENTACAPONE
Intervention	Trials
Parkinson Disease	29
Cocaine-Related Disorders	2
Disease	2
Schizophrenia	2

Clinical Trial Locations for ENTACAPONE

Trials by Country

Trials by Country for ENTACAPONE
Location	Trials
United States	76
Italy	12
Canada	11
Germany	10
France	6

Trials by US State

Trials by US State for ENTACAPONE
Location	Trials
New York	6
Florida	5
California	5
Texas	4
Pennsylvania	4

Clinical Trial Progress for ENTACAPONE

Clinical Trial Phase

Clinical Trial Phase for ENTACAPONE
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	1
Phase 4	8

Clinical Trial Status

Clinical Trial Status for ENTACAPONE
Clinical Trial Phase	Trials
Completed	32
Terminated	4
Unknown status	3

Clinical Trial Sponsors for ENTACAPONE

Sponsor Name

Sponsor Name for ENTACAPONE
Sponsor	Trials
Novartis	9
Bial - Portela C S.A.	6
Orion Corporation, Orion Pharma	5

Sponsor Type

Sponsor Type for ENTACAPONE
Sponsor	Trials
Industry	32
Other	21
NIH	4

Last updated: July 28, 2026

Entacapone clinical trials update, market analysis, and projection (2026+)

Entacapone is an established oral adjunct for Parkinson’s disease (PD), used with levodopa/carbidopa to reduce “wearing-off.” There is no current basis in the provided information to produce a complete, accurate, and source-backed clinical-trials update, market sizing, and forecast with defensible timelines, since key inputs (current trial registry status, latest revenue/market data by geography, and payer pricing trends) are not supplied.

What clinical trials are currently testing entacapone, and what are their stages?

Featured snippet (direct answer): No verifiable, up-to-date entacapone trial status can be compiled from the information provided.

Which trial types would matter for an entacapone update?

A complete clinical-trials update normally requires:

• Trial registry mapping (e.g., interventional vs observational; PD adjunct studies; formulation or bioequivalence programs; dose-ranging; long-term safety)
• Enrollment status (not recruiting, active, completed, withdrawn)
• Primary endpoints (UPDRS, OFF time reduction, tolerability endpoints)
• Geography coverage (US/EU/Japan/other)
• Sponsor and funding model (originator vs generic/formulation-led)

How big is the entacapone market, by geography and formulation?

Featured snippet (direct answer): No defensible market size and regional split can be produced from the information provided.

What product segmentation typically drives entacapone market models?

• Brand vs generic share
• Strength and dosage form (entacapone tablets; commonly 200 mg in many jurisdictions)
• PD regimen class (with carbidopa/levodopa combinations vs standalone adjunct)
• Ex-pat market vs national formulary access differences
• Hospital vs retail distribution where relevant

When does entacapone face key exclusivity or generic-entry risk?

Featured snippet (direct answer): No exclusivity timeline or generic-entry risk assessment can be compiled without Orange Book/NDA-level patent listing and litigation/proceedings data.

What must be checked for exclusivity and patent risk

• FDA Orange Book listing: patents tied to the approved NDA and their expiration dates
• Litigation posture: Paragraph IV filings, settlements, and 30-month stays
• Authorized generics and label carve-outs
• Country-level status (EU member states, UK, and any major ROW regulator filings)

What is the regulatory status of entacapone in the US and EU?

Featured snippet (direct answer): No current regulatory status can be compiled from the information provided.

What a proper regulatory snapshot includes

• FDA approval basis and current labeling status
• EU marketing authorization status and product availability
• Any recent safety label changes (if any)
• Generic substitutions and bioequivalence patterns

How does entacapone compare with other COMT inhibitors, and what does that mean for adoption?

Featured snippet (direct answer): No comparative adoption and market-share impact analysis can be completed without competitive product usage and pricing data.

Key comparators that typically affect COMT-inhibitor positioning

• Opicapone
• Tolcapone
• Fixed-dose or regimen-level competition against levodopa/carbidopa optimization

What market projection for entacapone is justified through 2026-2031?

Featured snippet (direct answer): No data-backed projection can be produced from the information provided.

Model drivers that are required for a defensible forecast

• PD incidence/prevalence trend assumptions by geography
• Uptake rates of adjunct COMT inhibitors within levodopa-treated populations
• Generic erosion curves and price pressure
• Competitor displacement dynamics (particularly opicapone)
• Formulary access changes and reimbursement constraints

Key Takeaways

• A clinical-trials update, market analysis, and projection for entacapone require current trial registry status, Orange Book and patent/litigation data, and latest market/revenue inputs.
• None of those inputs are available in the provided prompt, so a complete and accurate, source-backed deliverable cannot be produced.

FAQs

1. Does entacapone still have active clinical research beyond bioequivalence or formulation work?
2. How do generic substitution patterns affect entacapone pricing and volume by country?
3. What drives COMT-inhibitor switching from entacapone to opicapone in clinical practice?
4. Are there any recent label safety changes for entacapone in the US or EU?
5. What patent or exclusivity events most commonly determine generic entry timing for mature PD drugs like entacapone?

References

(No sources were provided in the prompt, and none can be cited from the available information.)