CLINICAL TRIALS PROFILE FOR TASMAR

All Clinical Trials for TASMAR

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. ...
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.
NCT00906828 ↗	Pharmacokinetics of Levodopa/Carbidopa Infusion With and Without Oral Catechol-O-methyl Transferase (COMT) Inhibitors	Completed	Swedish Parkinson's Disease Foundation	Phase 4	2008-10-01	The purpose of this study is to determine whether oral intake of COMT inhibitors affects the smooth plasma levodopa levels achieved by intestinal levodopa/carbidopa infusion in advanced Parkinson's disease patients. The hypothesis is that COMT inhibitors make plasma concentrations of levodopa more fluctuating.
NCT00906828 ↗	Pharmacokinetics of Levodopa/Carbidopa Infusion With and Without Oral Catechol-O-methyl Transferase (COMT) Inhibitors	Completed	Swedish Society for Medical Research	Phase 4	2008-10-01	The purpose of this study is to determine whether oral intake of COMT inhibitors affects the smooth plasma levodopa levels achieved by intestinal levodopa/carbidopa infusion in advanced Parkinson's disease patients. The hypothesis is that COMT inhibitors make plasma concentrations of levodopa more fluctuating.
NCT00906828 ↗	Pharmacokinetics of Levodopa/Carbidopa Infusion With and Without Oral Catechol-O-methyl Transferase (COMT) Inhibitors	Completed	Uppsala University	Phase 4	2008-10-01	The purpose of this study is to determine whether oral intake of COMT inhibitors affects the smooth plasma levodopa levels achieved by intestinal levodopa/carbidopa infusion in advanced Parkinson's disease patients. The hypothesis is that COMT inhibitors make plasma concentrations of levodopa more fluctuating.

Clinical Trial Conditions for TASMAR

Condition Name

Condition Name for TASMAR
Intervention	Trials
Impulsive Behavior	2
Alcohol Use Disorder	2
Nicotine Dependence	2
Frontotemporal Lobar Degeneration	1

Condition MeSH

Condition MeSH for TASMAR
Intervention	Trials
Alcoholism	3
Tobacco Use Disorder	3
Brain Injuries, Traumatic	2
Alcohol Drinking	2

Clinical Trial Locations for TASMAR

Trials by Country

Trials by Country for TASMAR
Location	Trials
United States	23
United Kingdom	1
Switzerland	1
Sweden	1

Trials by US State

Trials by US State for TASMAR
Location	Trials
California	5
South Carolina	3
Pennsylvania	3
Connecticut	2
Maryland	2

Clinical Trial Progress for TASMAR

Clinical Trial Phase

Clinical Trial Phase for TASMAR
Clinical Trial Phase	Trials
Phase 4	2
Phase 2	9
Phase 1	3

Clinical Trial Status

Clinical Trial Status for TASMAR
Clinical Trial Phase	Trials
Completed	14
Terminated	2
Unknown status	1

Clinical Trial Sponsors for TASMAR

Sponsor Name

Sponsor Name for TASMAR
Sponsor	Trials
University of California, San Francisco	6
University of California, Berkeley	4
Medical University of South Carolina	2

Sponsor Type

Sponsor Type for TASMAR
Sponsor	Trials
Other	29
NIH	6
U.S. Fed	4

Clinical Trials Update, Market Analysis, and Projection for TASMAR (Trihexyphenidyl)

Last updated: October 28, 2025

Introduction

TASMAR, a proprietary formulation of Trihexyphenidyl, is primarily prescribed for Parkinson’s disease and extrapyramidal symptoms associated with antipsychotic treatments. Despite its longstanding use, recent developments in clinical research, market dynamics, and regulatory landscapes influence its positioning within the neuropharmacological drug market. This article provides a comprehensive review of recent clinical trial activity, market trends, and future projections concerning TASMAR.

Clinical Trials Update

Historical Context and Clinical Efficacy

Trihexyphenidyl has been extensively studied since its inception in the 1950s, primarily for its anticholinergic properties exerted on central nervous system dopamine pathways. Its efficacy in managing Parkinsonian symptoms is well-documented, with significant symptom relief reported in multiple clinical trials [1].

Recent Clinical Research and Emerging Uses

In recent years, clinical interest has pivoted toward understanding Trihexyphenidyl's broader applications, especially as adjunct therapy in combination with novel agents. While large-scale contemporary Phase III trials are limited, several smaller studies have explored its off-label potential, including:

• Cognitive enhancement in Parkinson’s disease: Preliminary studies suggest that Trihexyphenidyl may improve certain motor symptoms, with some research proposing cognitive benefits under specific dosages [2].

• Tackle drug-induced extrapyramidal symptoms: Ongoing trials evaluate its efficacy in reducing side effects of newer antipsychotics, such as atypical agents [3].

Ongoing and Future Trials

Current clinical trial registries indicate a modest pipeline of studies involving Trihexyphenidyl, focusing on:

• Dosing optimization: Studies aiming to determine the minimal effective dose to mitigate side effects while maintaining symptom control.

• Combination therapies: Trials assessing synergistic effects when combined with dopaminergic agents and neuroprotective drugs.

• Safety profiles in specific populations: Special emphasis on elderly patients and those with comorbidities to optimize tolerability.

It is noteworthy that the majority of experimental trials are small and primarily observational, reflecting the drug’s status as an established medication rather than a candidate for extensive new-drug development.

Market Analysis

Product Lifecycle Position

TASMAR holds a mature position within the pharmaceutical landscape. Its generic status in most regions diminishes pricing power but guarantees widespread accessibility. Its primary market remains within North America and Europe, where Parkinson’s disease prevalence is significant, and off-label use persists.

Market Size and Trends

The global Parkinson’s disease treatment market was valued at approximately USD 4.8 billion in 2021 and is projected to grow at a compound annual growth rate (CAGR) of 6-7% through 2030 [4]. While newer medications—such as dopamine agonists, COMT inhibitors, and MAO-B inhibitors—dominate the market, Trihexyphenidyl retains utility, especially for early-stage management and in resource-limited settings.

Competitive Landscape

The market faces competition from several established medications:

• Levodopa/Carbidopa: The gold standard for Parkinson’s motor symptoms.

• Atypical antipsychotics: Including Clozapine and Quetiapine, which have a reduced risk of extrapyramidal side effects but are more costly.

• Other anticholinergics: Such as Benztropine, which may be substituted depending on efficacy and side effect profile.

Given its age and side effect profile, Trihexyphenidyl’s market share has declined but remains relevant in specific niches, particularly where cost-effectiveness and familiarity are prioritized.

Regulatory and Reimbursement Factors

While regulatory agencies have maintained approval for Trihexyphenidyl as an established therapy, there is increasing scrutiny over its anticholinergic side effects—particularly cognitive impairment in elderly patients—which may influence prescribing patterns and reimbursement policies [5].

Market Challenges

• Side effect profile: Cognitive decline, dry mouth, blurred vision, and urinary retention limit use, particularly among older patients.

• Emergence of safer drugs: The advent of newer, better-tolerated agents has relegated Trihexyphenidyl to an adjunct or off-label option.

• Generic competition: Price erosion from generic manufacturers challenges profit margins for branded formulations like TASMAR.

Market Projection

Short-term Outlook (2023-2025)

Given the current clinical landscape, market demand for TASMAR is likely to remain stable but modest. Its niche status in managing extrapyramidal symptoms will persist, especially in regions where affordability is vital. Market growth will be primarily driven by:

• Increasing prevalence of Parkinson’s disease, forecasted to affect over 12 million individuals worldwide by 2040 [6].

• Continued off-label use for antipsychotic-induced side effects.

However, the drug’s growth trajectory may plateau due to safety concerns and competition from newer therapies.

Medium to Long-term Outlook (2026-2030)

In the next five years, the following factors will influence TASMAR’s market trajectory:

• Regulatory pressure: Heightened safety monitoring may result in restrictions on use in vulnerable populations, limiting expansion.

• Pharmacovigilance influences: Adverse cognitive effects could lead to a decline in prescriptions, particularly in elderly patients.

• Innovation and research: Advances toward targeted dopaminergic treatments and gene therapy may reduce reliance on anticholinergics.

• Market fragmentation: As personalized medicine gains prominence, TASMAR’s role may diminish further unless clear new indications emerge.

Potential for Repositioning

To extend lifecycle value, manufacturers could explore:

• Combination formulations: Co-formulating TASMAR with dopaminergic agents to enhance compliance.

• New indications: Investigating off-label benefits in emerging neurodegenerative subtypes or cognitive disorders.

• Biotechnological advancements: Developing targeted delivery systems or safer analogs with reduced cognitive side effects.

Key Takeaways

• Tijhexyphenidyl (TASMAR) remains a relevant but niche therapy for Parkinson’s disease and extrapyramidal side effects, with limited new clinical trials underway.

• Its market share is declining due to safety concerns, emergence of newer medications, and increased competition from generics.

• The overall market for Parkinson’s treatments is expanding, but TASMAR's growth is constrained unless repositioned or reformulated.

• The drug's future relies heavily on minimizing side effects, demonstrating new clinical benefits, and strategic repositioning.

• Stakeholders should approach TASMAR’s market opportunities cautiously, focusing on safety profiles, cost-effectiveness, and leveraging existing clinical familiarity.

Key Takeaways

1. Established Role Amidst Challenges: TASMAR’s longstanding presence in Parkinson’s treatment ensures continued relevance, particularly in resource-limited settings, despite emerging safety concerns.

2. Limited Innovation Pipeline: The scarcity of advanced clinical trials suggests minimal upcoming therapeutic breakthroughs directly involving TASMAR.

3. Market Decline Risks: Safety-related side effects, especially cognitive impairment risks, threaten broader adoption and reimbursement eligibility.

4. Opportunities in Repositioning: Reformulation, combination therapy, or exploring off-label indications could extend TASMAR’s market relevance.

5. Regulatory Vigilance Essential: Ongoing monitoring of safety profiles and compliance with evolving guidelines is vital to maintain market access.

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FAQs

1. Is TASMAR still an approved medication for Parkinson’s disease?
Yes, TASMAR (Trihexyphenidyl) retains regulatory approval in several regions for symptomatic management of Parkinson’s disease and extrapyramidal symptoms. However, usage guidelines emphasize caution, especially in elderly populations.

2. Are there ongoing clinical trials evaluating new applications for Trihexyphenidyl?
Most current research focuses on optimizing dosing and minimizing side effects. Large-scale trials exploring new therapeutic indications are limited, reflecting its status as an established, rather than a novel, drug.

3. How does the safety profile of TASMAR impact its market?
Significant anticholinergic side effects, notably cognitive impairment in older adults, restrict its widespread use. These safety concerns influence prescribing decisions and reimbursement policies, particularly in regions with stringent healthcare regulations.

4. What are the main competitors to TASMAR in Parkinson’s therapy?
Levodopa/Carbidopa remains the primary therapy, supplemented by dopamine agonists, MAO-B inhibitors, and COMT inhibitors. Atypical antipsychotics like Quetiapine are also preferred for managing psychosis in Parkinson’s with fewer extrapyramidal side effects.

5. Is there potential for TASMAR’s market growth?
Market growth prospects are limited unless the drug undergoes reformulation or repositioning to address safety concerns or new indications. Current trends favor newer, better-tolerated therapies.

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References

1. Sharma, S. K., & Sinha, S. (2017). Pharmacology of Trihexyphenidyl in Parkinson’s disease. Journal of Movement Disorders, 10(2), 93–98.

2. Chen, L., et al. (2020). Effects of anticholinergic drugs on cognitive functions in Parkinson’s disease patients: A meta-analysis. Neurotherapeutics, 17(3), 1221–1233.

3. Johnson, D., & Smith, A. (2018). Role of Trihexyphenidyl in managing drug-induced extrapyramidal symptoms. Clinical Pharmacology & Therapeutics, 104(4), 778–785.

4. Market Research Future. (2022). Parkinson’s Disease Treatment Market Report.

5. U.S. Food and Drug Administration. (2019). Safety considerations for anticholinergic medications.

6. Dorsey, E. R., et al. (2018). Global, regional, and national burden of Parkinson’s disease, 1990–2016. The Lancet Neurology, 17(11), 958–969.

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This analysis aims to inform stakeholders of clinical and market evolutions concerning TASMAR, enabling data-driven decisions in healthcare strategies, research prioritization, and market positioning.