CLINICAL TRIALS PROFILE FOR COMTAN

All Clinical Trials for COMTAN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00262470 ↗	Treatment of Orthostatic Intolerance	Active, not recruiting	National Institutes of Health (NIH)	Phase 1/Phase 2	1997-04-01	This trial is designed to study the effects of various mechanistically unique medications in controlling excessive increases in heart rate with standing and in improving the symptoms of orthostatic intolerance in patients with this disorder.
NCT00262470 ↗	Treatment of Orthostatic Intolerance	Active, not recruiting	Satish R. Raj	Phase 1/Phase 2	1997-04-01	This trial is designed to study the effects of various mechanistically unique medications in controlling excessive increases in heart rate with standing and in improving the symptoms of orthostatic intolerance in patients with this disorder.
NCT00547911 ↗	Augmenting Effects of L-DOPS With Carbidopa and Entacapone	Terminated	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 1/Phase 2	2007-10-01	An experimental drug called L-DOPS increases production in the body of a messenger chemical called norepinephrine. Cells in the brain that make norepinephrine are often gone in Parkinson disease. The exact consequences of this loss are unknown, but they may be related to symptoms such as fatigue, depression, or decreased attention that occur commonly in Parkinson disease. This study will explore effects of L-DOPS in conjunction with carbidopa and entacapone, which are drugs used to treat Parkinson disease. We wish to find out what the effects are of increasing norepinephrine production in the brain and whether carbidopa and entacapone augment those effects. Volunteers for this study must be at least 18 years of age and able to give consent to participate in the study. To participate in the study, volunteers must discontinue use of alcohol, tobacco, and certain herbal medicines or dietary supplements, and must also taper or discontinue certain kinds of medications that might interfere with the results of the study. Candidates will be screened with a medical history and physical exam. Participants will be admitted to the National Institutes of Health Clinical Center for two weeks of testing. The study will have three testing phases in a randomly chosen order for each participant: - Single dose of L-DOPS - Single dose of L-DOPS in conjunction with carbidopa - Single dose of L-DOPS in conjunction with entacapone Each phase will last two days, with a washout day between each phase in which no drugs will be given and no testing will be performed. In each phase, participants will undergo a series of tests and measurements, including blood pressure and electrocardiogram tests. Participants who are healthy volunteers will also have blood drawn and will undergo a lumbar puncture (also known as a spinal tap) to obtain spinal fluid for chemical tests.
NCT02058966 ↗	Pilot Study of Entacapone for Methamphetamine Abuse	Completed	Portland VA Medical Center	Early Phase 1	2014-06-01	Addiction to methamphetamine is a serious health problem. There are no medications that a doctor can give someone to help them stop using methamphetamine. Entacapone (Comtan©) is a medication that could help people addicted to methamphetamine. This study will see how entacapone works in healthy people who are given methamphetamine. We think that the study drug will be well tolerated, and that it will prevent some of the effects of methamphetamine that make it so addictive. We also want to see how differences in people's genes may cause differences in the ways the study drug and methamphetamine work for them. The study has six total visits. The first visit is for screening. Tests and procedures will make sure it is safe for subjects to participate. The second visit is a familiarization day. Subjects will receive methamphetamine, but no entacapone. This is done to make sure they can tolerate the drug and recognize its effects before being given a second drug on the same day. Subjects will take surveys and computer tests to see how the medications change mood, thinking, and liking the drug. The final four visits are the actual study days. Subjects will be randomly assigned (like the flip of a coin) to the different ways to get either 1) study medication or placebo (placebo contains no active study medication) and then 2) methamphetamine or placebo. Subjects will be in all four groups during the study, which means that each day a subject will get a different group.
NCT02058966 ↗	Pilot Study of Entacapone for Methamphetamine Abuse	Completed	Oregon Health and Science University	Early Phase 1	2014-06-01	Addiction to methamphetamine is a serious health problem. There are no medications that a doctor can give someone to help them stop using methamphetamine. Entacapone (Comtan©) is a medication that could help people addicted to methamphetamine. This study will see how entacapone works in healthy people who are given methamphetamine. We think that the study drug will be well tolerated, and that it will prevent some of the effects of methamphetamine that make it so addictive. We also want to see how differences in people's genes may cause differences in the ways the study drug and methamphetamine work for them. The study has six total visits. The first visit is for screening. Tests and procedures will make sure it is safe for subjects to participate. The second visit is a familiarization day. Subjects will receive methamphetamine, but no entacapone. This is done to make sure they can tolerate the drug and recognize its effects before being given a second drug on the same day. Subjects will take surveys and computer tests to see how the medications change mood, thinking, and liking the drug. The final four visits are the actual study days. Subjects will be randomly assigned (like the flip of a coin) to the different ways to get either 1) study medication or placebo (placebo contains no active study medication) and then 2) methamphetamine or placebo. Subjects will be in all four groups during the study, which means that each day a subject will get a different group.
NCT02349243 ↗	Effect of Entacapone on Bodyweight Loss in Obese Population	Unknown status	National Institute of Biological Sciences, Beijing	Phase 1/Phase 2	2015-01-01	This is a randomized, controlled, double blind clinical trial. The purpose of this study is to investigate the weight loss efficacy of entacapone. In this study, participants are randomly divided into entacapone and placebo groups. The percentage change in body weight, the body mass index, waist circumstance, extent of fatty liver, quantity of visceral fat, serum insulin, serum triglyceride and the adverse effects are compared between the two groups.

Clinical Trial Conditions for COMTAN

Condition Name

Condition Name for COMTAN
Intervention	Trials
Parkinson Disease	2
Multiple System Atrophy	2
Parkinson's Disease (PD)	1
Pure Autonomic Failure	1

Condition MeSH

Condition MeSH for COMTAN
Intervention	Trials
Parkinson Disease	3
Multiple System Atrophy	2
Atrophy	2
Shy-Drager Syndrome	2

Clinical Trial Locations for COMTAN

Trials by Country

Trials by Country for COMTAN
Location	Trials
United States	4
China	2

Trials by US State

Trials by US State for COMTAN
Location	Trials
Tennessee	2
Oregon	1
Maryland	1

Clinical Trial Progress for COMTAN

Clinical Trial Phase

Clinical Trial Phase for COMTAN
Clinical Trial Phase	Trials
Phase 2	1
Phase 1/Phase 2	3
Phase 1	1

Clinical Trial Status

Clinical Trial Status for COMTAN
Clinical Trial Phase	Trials
Unknown status	2
Completed	2
Terminated	1

Clinical Trial Sponsors for COMTAN

Sponsor Name

Sponsor Name for COMTAN
Sponsor	Trials
National Institute of Neurological Disorders and Stroke (NINDS)	1
Portland VA Medical Center	1
Oregon Health and Science University	1

Sponsor Type

Sponsor Type for COMTAN
Sponsor	Trials
Other	6
NIH	2
U.S. Fed	1

Last updated: April 30, 2026

Comtan (entacapone): Clinical-Trial Status, Market Snapshot, and Projection

What is Comtan and what indications does it cover?

Comtan is entacapone, a COMT (catechol-O-methyltransferase) inhibitor used as adjunct therapy to levodopa/carbidopa in Parkinson’s disease to extend the effect of each levodopa dose.

Regulatory positioning (label basis)

• Core use: Adjunct to levodopa/carbidopa in Parkinson’s disease patients experiencing “end-of-dose” deterioration (clinical label language varies by jurisdiction).
• Oral dosing form: Entacapone tablets (marketed dosing patterns are typically 200 mg with each levodopa dose taken per label).

What clinical-trial activity is visible for entacapone/Comtan?

Entacapone is an established, marketed product with a long clinical record. Current “active” registrational trials for entacapone tend to be limited; most new work in the Parkinson’s enzyme-inhibition space is concentrated in:

• Novel COMT inhibitors,
• Levodopa formulation strategies (extended-release levodopa/carbidopa),
• Combination therapies,
• Real-world effectiveness and safety rather than large phase 3 registrational programs.

At the same time, entacapone continues to show up in:

• Post-marketing observational studies,
• Comparative effectiveness research and healthcare database analyses,
• Pragmatic trials where entacapone is a background comparator.

Key takeaway for trial outlook: the pipeline signal for entacapone is low versus the broader Parkinson’s “late-cycle” landscape, with value mostly coming from established clinical use and payer/real-world evidence rather than new phase 3 registration.

What does the market look like for entacapone (Comtan)?

Entacapone operates in a mature segment of Parkinson’s therapeutics. Market dynamics are shaped by:

• Generic penetration (multiple jurisdictions have multiple generic alternatives to branded entacapone),
• Substitution pressure from other adjunct Parkinson’s agents (notably COMT inhibitors and dopamine agonist or MAO-B inhibitor classes),
• Preference shifts driven by dosing convenience and formulary decisions,
• Aging Parkinson’s demographics that support class-level volume stability even when branded share erodes.

Commercial reality

• Branded Comtan revenues generally track class demand but face persistent decline pressure where generics dominate.
• Forecasts for entacapone typically focus on total class volume and share-of-therapy rather than brand-driven growth.

How do competitors affect Comtan’s outlook?

In Parkinson’s add-on therapy markets, entacapone’s competitive set includes:

• Other COMT inhibitors (class-level substitution),
• Adjunct dopaminergic strategies that reduce “wearing-off” symptoms (class mix shifts at the margin),
• Extended-release levodopa formulations that change the need for COMT inhibition.

Practical implication: even if total Parkinson’s diagnosed population grows, entacapone’s branded share tends to hold only if payers maintain stable coverage and if patient-specific response favors entacapone over alternatives.

What is the patent and exclusivity context that drives projections?

Entacapone is not in a “modern” branded exclusivity growth cycle. Market projections for Comtan are therefore governed mainly by:

• Generic erosion of branded pricing, and
• Whether local regulatory status still protects any branded formulation/packaging or method-of-use life-cycle claims.

Because entacapone is already established, valuation and R&D strategy typically pivot to:

• Lifecycle patents (formulation, dosing regimen, specific method claims),
• New combinations or new patient subgroups,
• Evidence generation rather than new drug entity launches.

Market analysis and projection

Projection framing (what matters for numbers) For a mature, generics-exposed Parkinson adjunct, the forecast variables that typically dominate are:

1. Diagnosed Parkinson’s prevalence growth (demand headwind/benefit depending on treatment uptake),
2. Class penetration for “wearing-off” management,
3. Generic price levels and payer reimbursement, which drive revenue even if units remain stable.

Base-case directional forecast

• Unit demand: likely stable to mildly growing over the medium term as treated patient numbers rise with prevalence.
• Revenue for branded Comtan: likely flat to declining as branded pricing compresses and generic substitutes dominate.
• Competitive share: may drift depending on local formularies and treatment guidelines for adjunct “wearing-off” therapy.

Commercial risk profile

• Payer pressure: persistent, especially in markets with broad generic access.
• Guideline drift: changes in preferred adjunct strategy can reallocate share within Parkinson’s “wearing-off” management.
• Safety and tolerability: while entacapone has established tolerability data, any class-level shift away from COMT inhibitors affects share more than it affects overall Parkinson treatment volume.

What is the investment and R&D implication?

Given the mature status of entacapone:

• Brand strategy: prioritize contracting and formulary positions rather than growth.
• R&D strategy (if pursued in the entacapone space): concentrate on lifecycle research such as adherence, combination dosing convenience, or observational evidence rather than large new phase 3 programs, unless tied to a protected IP angle.

Key Takeaways

• Comtan is entacapone, an adjunct to levodopa/carbidopa for Parkinson’s disease “wearing-off” management.
• Clinical-trial visibility for entacapone is limited versus newer Parkinson’s pipelines; ongoing evidence activity is more likely observational or comparative than registrational.
• Market growth is driven by Parkinson’s prevalence, but branded Comtan faces generic erosion, making branded revenue upside constrained.
• Projections should be built around class-level volume stability and payer-driven price compression, not branded unit expansion.
• Competitive substitution within “wearing-off” adjunct therapy is the key share risk.

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FAQs

Is Comtan still actively studied in new trials?

Clinical activity for entacapone is generally more consistent with observational and comparative studies than with new large registrational programs.

What most affects Comtan revenue projections?

Generic pricing and formulary placement have the largest effect on branded revenue, even if overall Parkinson’s treated populations grow.

Does Parkinson’s prevalence growth help entacapone demand?

Yes, prevalence growth typically supports class-level unit demand, though share shifts within adjunct therapy can limit entacapone share gains.

What are the main competitive risks for entacapone?

Substitution from other adjunct strategies for “wearing-off,” including other COMT inhibitors and alternative dopaminergic/levodopa optimization approaches, can shift market share.

Is there meaningful patent-driven upside for Comtan?

Entacapone is in a mature stage; projections for Comtan usually depend more on market access and generics dynamics than on fresh entity-level exclusivity.

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Sources

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