CLINICAL TRIALS PROFILE FOR TOLCAPONE

All Clinical Trials for TOLCAPONE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00033059 ↗	Assessment of Potential Interactions Between Cocaine and Tolcapone - 1	Unknown status	National Institute on Drug Abuse (NIDA)	Phase 1	2001-07-01	The purpose of this study is to assess the potential interactions between intravenous (IV) cocaine and tolcapone.
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. ...
NCT00548327 ↗	The Effects of Atomoxetine on Cognition and Brain Function Based on Catechol-O-methyltransferase(COMT) Genotype	Terminated	National Institute of Mental Health (NIMH)	Phase 2	2007-10-01	This study will evaluate whether Atomoxetine improves cognition in healthy volunteers as well as patients with schizophrenia. Atomoxetine is a drug that has been Food and Drug Administration (FDA) approved for Attention Deficit Disorder and allegedly increase the amount of the neurotransmitter dopamine in the frontal cortex of the brain.
NCT00604591 ↗	Effects of Tolcapone on Frontotemporal Dementia	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2	2011-07-01	This study will test the effects of a medication called tolcapone on cognitive, behavioral, and language problems seen in patients with frontotemporal dementia (FTD). Tolcapone increases the amount of dopamine, a brain chemical that may be lowered in FTD. The study will see if tolcapone can improve thinking, behavior, and language in people with FTD and will look at the effects of the drug on brain activity. Patients with FTD who are between 40 and 85 years of age may be eligible for this study. Participants will be seen as outpatients at the Columbia University Medical Center approximately one a week for 4 weeks. They take tolcapone or a placebo (a look-alike pill with no active ingredient) during study week 1. During study week 3, those who took placebo during week 1 now take tolcapone for 1 week and those who took tolcapone now take placebo. In addition, patients undergo the following tests and procedures: - Neurological tests to evaluate attention, problem-solving and memory. These tests are repeated several times during the course of the study. - Test to look for a gene that affects the amount of dopamine in the brain, using blood samples collected in a previous study. - Blood draws four times during the study. - Functional MRI (fMRI) to learn about changes in brain regions that are involved in performing tasks. For fMRI, the patient lies on a table that can slide in and out of the scanner, a narrow metal cylinder surrounded by a magnetic field. The procedure takes about 60 minutes and is performed four times over the course of the . FMRI involves taking pictures of the brain during MRI while the subject performs a task so that changes in the brain that occur during these tasks can be studied.
NCT00604591 ↗	Effects of Tolcapone on Frontotemporal Dementia	Completed	Columbia University	Phase 2	2011-07-01	This study will test the effects of a medication called tolcapone on cognitive, behavioral, and language problems seen in patients with frontotemporal dementia (FTD). Tolcapone increases the amount of dopamine, a brain chemical that may be lowered in FTD. The study will see if tolcapone can improve thinking, behavior, and language in people with FTD and will look at the effects of the drug on brain activity. Patients with FTD who are between 40 and 85 years of age may be eligible for this study. Participants will be seen as outpatients at the Columbia University Medical Center approximately one a week for 4 weeks. They take tolcapone or a placebo (a look-alike pill with no active ingredient) during study week 1. During study week 3, those who took placebo during week 1 now take tolcapone for 1 week and those who took tolcapone now take placebo. In addition, patients undergo the following tests and procedures: - Neurological tests to evaluate attention, problem-solving and memory. These tests are repeated several times during the course of the study. - Test to look for a gene that affects the amount of dopamine in the brain, using blood samples collected in a previous study. - Blood draws four times during the study. - Functional MRI (fMRI) to learn about changes in brain regions that are involved in performing tasks. For fMRI, the patient lies on a table that can slide in and out of the scanner, a narrow metal cylinder surrounded by a magnetic field. The procedure takes about 60 minutes and is performed four times over the course of the . FMRI involves taking pictures of the brain during MRI while the subject performs a task so that changes in the brain that occur during these tasks can be studied.

Clinical Trial Conditions for TOLCAPONE

Condition Name

Condition Name for TOLCAPONE
Intervention	Trials
Schizophrenia	3
Nicotine Dependence	2
Obsessive-Compulsive Disorder	2
Alcohol Use Disorder	2

Condition MeSH

Condition MeSH for TOLCAPONE
Intervention	Trials
Tobacco Use Disorder	3
Disease	3
Alcoholism	3
Schizophrenia	3

Clinical Trial Locations for TOLCAPONE

Trials by Country

Trials by Country for TOLCAPONE
Location	Trials
United States	28
Germany	1
Switzerland	1
Spain	1
Sweden	1

Trials by US State

Trials by US State for TOLCAPONE
Location	Trials
California	7
Maryland	3
South Carolina	3
Pennsylvania	3
Connecticut	2

Clinical Trial Progress for TOLCAPONE

Clinical Trial Phase

Clinical Trial Phase for TOLCAPONE
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	3
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for TOLCAPONE
Clinical Trial Phase	Trials
Completed	17
Recruiting	3
Terminated	3

Clinical Trial Sponsors for TOLCAPONE

Sponsor Name

Sponsor Name for TOLCAPONE
Sponsor	Trials
University of California, San Francisco	7
University of California, Berkeley	5
National Institute on Drug Abuse (NIDA)	3

Sponsor Type

Sponsor Type for TOLCAPONE
Sponsor	Trials
Other	35
NIH	8
U.S. Fed	4

TOLCAPONE Market Analysis and Financial Projection

Last updated: April 25, 2026

Tolcapone: Clinical Trial Update, Market Analysis, and Revenue Projection

What is tolcapone and where does it sit in development?

Tolcapone is a COMT (catechol-O-methyltransferase) inhibitor used to treat Parkinson’s disease (PD) by extending levodopa effect. In markets where it is approved, the product is typically positioned as an adjunct to levodopa/carbidopa in patients with “end-of-dose” motor fluctuations.

Development status (clinical trials):

• No new late-stage (Phase 3) tolcapone registration trials are evident from public clinical trial registries at the current time based on the available information in this workspace.
• Publicly visible clinical activity appears limited and older relative to modern PD combination and device-based approaches (levodopa formulations, dopamine agonists, MAO-B inhibitors, COMT alternatives like entacapone).
• Focus of any ongoing work (when present in public sources) is generally supportive (formulation, pharmacokinetics, adherence, or post-marketing studies), rather than new efficacy pivot trials.

Which trials matter most for tolcapone today?

Given the absence of identifiable active Phase 3 registration trials in the available source material here, the most actionable view is:

• Tolcapone’s value is anchored in approved use rather than current incremental clinical readouts.
• Competitive dynamics are driven by substitution among COMT inhibitors and by broader PD standard-of-care shifts, not by new tolcapone trial breakthroughs.

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How big is the tolcapone addressable market?

What is the disease pool for tolcapone use?

Tolcapone targets a subset of PD patients who experience motor fluctuations on levodopa therapy. The relevant commercial addressable pool is:

1. Prevalent PD patients
2. On levodopa therapy
3. With end-of-dose wearing off or motor fluctuations requiring COMT inhibition

Key market shaping facts:

• COMT inhibitor penetration varies by country and payer criteria.
• Enabling drugs and clinical pathways strongly influence which COMT inhibitor is used first.
• Entacapone and other alternatives have historically captured more momentum due to dosing convenience, formulary position, and prescriber familiarity (market outcomes consistent with class competition dynamics rather than tolcapone-specific trial milestones).

Market sizing framework used for projection

Because this workspace does not include live epidemiology, payer mix, or current pricing filings, a projection can only be expressed as a driver-based model using bounded assumptions tied to:

• PD prevalence
• levodopa utilization
• wearing-off prevalence among treated patients
• COMT inhibitor adoption rate
• tolcapone share among COMT inhibitors
• net price after rebates and distribution costs

Under that framework, the actionable conclusion is:

• Tolcapone’s market is structurally smaller than class leaders and depends heavily on remaining approvals, payer inclusion, and neurologist prescribing habits rather than new trial catalysts.

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Who competes with tolcapone?

What are the main competitive substitutes?

Tolcapone faces two layers of competition:

1) Same-mechanism substitutes (COMT inhibitors)

• Entacapone is the primary class substitute in many markets.
• Treatment preference often follows formulary positioning, dosing and logistics, and local safety monitoring practices.

2) Broader PD standard-of-care alternatives

• MAO-B inhibitors, dopamine agonists, and newer levodopa formulations reduce reliance on COMT inhibitors depending on patient profile.
• Advanced therapies (including device-aided treatments in some markets) can reduce the share of patients seeking oral add-ons.

Competitive implication: In absence of fresh late-stage efficacy or differentiation data, tolcapone competes mainly on access, tolerability management, and clinician habits rather than incremental evidence.

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Clinical and regulatory signals that drive commercialization

What non-trial factors influence tolcapone uptake?

Even with no new late-stage trials visible in the available record, tolcapone uptake is influenced by:

• Safety governance and prescriber monitoring
  COMT inhibitor prescribing is constrained by risk management protocols. Payer coverage and provider willingness track these constraints.
• Formulary access and tender dynamics
  Many PD formularies consolidate to one preferred COMT inhibitor.
• Switching behavior within class
  When a preferred alternative is stocked, tolcapone use often declines unless it is specifically required for that patient.

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Tolcapone revenue projection (base case)

What does a practical projection look like without new Phase 3 catalysts?

With tolcapone anchored to existing label utility and with the clinical trial surface showing no new late-stage pivot in the available record, a reasonable projection method is to model:

• Volume stability with gradual share erosion to class competitors
• Price stability/limited downside depending on national procurement and competitive pressures
• Net sales as a function of covered patient share

Projection logic (directional):

• Base case: low-single-digit annual growth or flat volume, with slight share drag versus entacapone and alternative PD regimens
• Bear case: accelerated share loss due to formulary tightening and risk management friction
• Bull case: stabilization if specific guideline pathways or payer coverage remain favorable

Scenario table (index-based, not currency-specific)

Because this workspace does not include current net pricing, country-level reimbursement, or audited sales history, the model is presented as an indexed outcome versus a notional baseline year (Index = 100).

Scenario	Annual volume trend	Annual net price trend	Net sales index (Year 1)	Net sales index (Year 3)
Bear	-3%	0%	97	91
Base	-1%	+0.5%	99.5	98
Bull	+1%	+0.5%	101.5	105

Interpretation for investors and R&D planners:

• Tolcapone’s profit pool behaves like a mature, coverage-driven franchise, not a trial-driven growth story.
• The projection is most sensitive to formulary share among COMT inhibitors and to whether payer/risk governance restricts initiation.

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What to watch next (commercially actionable signals)

Which signals change the tolcapone trajectory fastest?

In the absence of visible late-stage trial catalysts, the fastest movers are:

• Formulary and reimbursement updates (preferred COMT inhibitor decisions)
• Safety management policy updates that affect initiation and continuation
• Guideline revisions that alter the sequencing of add-on therapies for wearing-off
• Channel dynamics (tender awards, hospital stocking, and pharmacy substitution)

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Key Takeaways

• Tolcapone is an established COMT inhibitor for levodopa-treated Parkinson’s disease patients with motor fluctuations; the current development picture in the available record shows no visible late-stage registration catalysts.
• Market potential is driven by PD prevalence, wearing-off prevalence, levodopa utilization, and tolcapone’s share among COMT inhibitors.
• Competitive substitution is dominated by entacapone and broader PD regimen alternatives, with formulary access and safety governance as the strongest determinants of performance.
• A practical revenue model without new Phase 3 drivers yields mature-franchise behavior: base case near-flat sales, bear case mild decline, bull case low growth.

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FAQs

1. Is tolcapone currently in late-stage clinical development?
   The available record shows no evident active Phase 3 registration trial landscape for tolcapone in this workspace.

2. What determines tolcapone market share versus entacapone?
   The biggest practical drivers are formulary preference, reimbursement positioning, and prescriber willingness under safety monitoring protocols.

3. Does tolcapone have a growth story based on new clinical efficacy results?
   Based on the available information here, growth is not trial-catalyzed; it is coverage- and utilization-driven.

4. How sensitive are projections to pricing?
   In mature PD franchise settings, net pricing matters, but covered patient share and persistence typically dominate.

5. What are the earliest commercial signals to monitor?
   Tender/formulary updates, guideline sequencing changes, and safety governance changes are the earliest leading indicators.

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References

No sources are available in this workspace to cite for clinical trial status, epidemiology inputs, reimbursement data, or sales benchmarks for tolcapone.