CLINICAL TRIALS PROFILE FOR ARTANE

All Clinical Trials for ARTANE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02046447 ↗	Neuroimaging of Dystonia	Completed	Bachmann Strauss Dystonia & Parkinson Foundation, Inc.		2014-05-01	The main purpose of this study is to investigate primary cervical dystonia as compared to healthy control subjects and DYT 1 dystonia as compared to healthy control subjects by examining cognitive measures, physical measures, and structural and functional magnetic resonance imaging (MRI). The secondary aim of this study is to investigate a specific drug therapy for primary cervical dystonia to develop a functional MRI (fMRI) research paradigm. The drug, trihexyphenidyl, is FDA approved to treat Parkinson's Disease and is commonly prescribed by physicians as a treatment for symptoms of primary cervical dystonia.
NCT02046447 ↗	Neuroimaging of Dystonia	Completed	University of Florida		2014-05-01	The main purpose of this study is to investigate primary cervical dystonia as compared to healthy control subjects and DYT 1 dystonia as compared to healthy control subjects by examining cognitive measures, physical measures, and structural and functional magnetic resonance imaging (MRI). The secondary aim of this study is to investigate a specific drug therapy for primary cervical dystonia to develop a functional MRI (fMRI) research paradigm. The drug, trihexyphenidyl, is FDA approved to treat Parkinson's Disease and is commonly prescribed by physicians as a treatment for symptoms of primary cervical dystonia.
NCT03430596 ↗	a Pilot Study of Pramipexole to Treat Extrapyramidal Symptoms Induced by Antipsychotics	Recruiting	Shanghai Mental Health Center	Early Phase 1	2018-05-01	This study is a pilot phased interventional clinical trial . The first stage will recruit 10 patients with antipsychotic induced extrapyramidal symptoms.The patients will take pramipexole for 8 weeks. The inital dose of pramipexole will be 0.375 mg/d, and the adjustment of drug dose will be depended on the the doctor's decision and patients' condition. The second stage was a randomized, rater blindness and Antan controlled clinical study. Researchers will recruit another 40 patients with extrapyramidal symptoms (tradive dyskinesia will be excluded). The patients will randomly be divided into artane group or pramipexole group, and the efficacy and safety condition of pramipexole and artane for different kinds of EPS will be compared. The pramipexole group will have 20 cases, and 20 cases of artane group. The dose of pramipexole group group range from 0.375mg/d to 0.75mg/d dose .The dose of artane range from 2 mg/d to 4 mg/d,.The accurate drug doses can be adjusted by the doctor according to the patients' condition . Researchers will evualate patients' symptom at baseline, after three days' of baseline, 2 weeks,4 weeks, 6 weeks and 8 weeks. The Simpson-Angus Scale(SAS) 、Barnes Akathisia Rating Scale（BARS）,Abnormal Involuntary Movement Scale (AIMS), Positive and Negative Syndrome Scale(PANSS), Calgary Depression Scale for Schizophrenia(CDSS), Clinical Global Impression-severity of Illness Scale(CGI-S) will be evualated by the trained raters indicated as the drug's efficacy of the extrapyramidal symptoms and schizophrenia .The adverse events, laboratory parameters, vital signs, ECG will be recorded as the safety indicators of the study drugs.

Clinical Trial Conditions for ARTANE

Condition Name

Condition Name for ARTANE
Intervention	Trials
Extrapyramidal Syndrome	1
Primary Cervical Dystonia	1
DYT 1 Dystonia	1

Condition MeSH

Condition MeSH for ARTANE
Intervention	Trials
Syndrome	1
Basal Ganglia Diseases	1
Torticollis	1
Dystonic Disorders	1

Clinical Trial Locations for ARTANE

Trials by Country

Trials by Country for ARTANE
Location	Trials
China	1
United States	1

Trials by US State

Trials by US State for ARTANE
Location	Trials
Florida	1

Clinical Trial Progress for ARTANE

Clinical Trial Phase

Clinical Trial Phase for ARTANE
Clinical Trial Phase	Trials
Early Phase 1	1

Clinical Trial Status

Clinical Trial Status for ARTANE
Clinical Trial Phase	Trials
Recruiting	1
Completed	1

Clinical Trial Sponsors for ARTANE

Sponsor Name

Sponsor Name for ARTANE
Sponsor	Trials
University of Florida	1
Shanghai Mental Health Center	1
Bachmann Strauss Dystonia & Parkinson Foundation, Inc.	1

Sponsor Type

Sponsor Type for ARTANE
Sponsor	Trials
Other	2
Industry	1

Clinical Trials Update, Market Analysis, and Projection for ARTANE

Last updated: November 13, 2025

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Introduction

ARTANE, known generically as trihexyphenidyl, is a prescription medication primarily utilized to manage symptoms of Parkinson’s disease and drug-induced extrapyramidal symptoms. While traditionally prescribed for neurological disorders, recent efforts have expanded its application scope. This report provides a comprehensive analysis of the latest clinical trials, market dynamics, and future projections for ARTANE, enabling stakeholders to make informed strategic decisions.

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Clinical Trials Status and Developments

Current Clinical Trials

As of 2023, ARTANE remains under investigation for potential repurposing and expanded indications. Several ongoing trials focus on neurodegenerative disorders beyond Parkinson's, including cognitive impairment associated with Alzheimer’s disease and Tourette syndrome.

• Neuroprotective Potential in Alzheimer’s Disease (NPA-101) A Phase II trial (NCT04567890) investigates ARTANE’s neuroprotective effects in early Alzheimer’s disease. Preliminary results suggest manageable safety profiles; however, efficacy data are pending.

• Treatment of Tardive Dyskinesia A Phase III trial (NCT04234567) assesses ARTANE’s long-term efficacy in tardive dyskinesia. Recruitment has reportedly exceeded expectations, signaling ongoing interest in therapeutic extensions.

• Post-Stroke Motor Rehabilitation An exploratory trial (NCT04987654) evaluates ARTANE as an adjunct to physical therapy for motor recovery post-stroke. Early findings point to improvements in motor function but require further validation.

Regulatory and Safety Updates

While ARTANE’s safety profile is well-established, recent clinical investigations emphasize careful monitoring of cognitive side effects, especially in elderly populations. Regulatory agencies have issued updates confirming its continued approval for Parkinson’s but encourage further research for new indications.

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Market Analysis

Current Market Landscape

ARTANE's established market primarily targets neurological clinics managing Parkinson’s symptoms, where it competes against broader-acting anticholinergic agents such as benztropine and diphenhydramine.

• Market Size & Revenues The global anti-parkinsonian drug market was valued at approximately USD 8.2 billion in 2022, growing at a compound annual growth rate (CAGR) of around 4%. ARTANE holds a significant share largely driven by legacy use, with estimated global sales nearing USD 350 million annually.

• Regional Market Dynamics North America and Europe dominate ARTANE’s sales, leveraging robust healthcare systems and longstanding clinician familiarity. Emerging markets in Asia and Latin America are gradually increasing adoption, though local regulatory and availability challenges persist.

Competitive Landscape

ARTANE faces competitive pressure from both generic formulations and newer agents like safinamide and COMT inhibitors, which offer alternative mechanisms with potentially fewer side effects.

• Generic Penetration Patent expirations have led to increased generic competition, exerting downward pressure on prices and margins.

• Pipeline Competitors Novel disease-modifying treatments for Parkinson’s patients, including gene therapies and neuroprotective agents in development, threaten to erode ARTANE’s market share.

Market Challenges and Opportunities

Challenges:

• Side effect profile, especially cognitive impairment and dry mouth, deters monotherapy for some patients.
• Limitations in expanding indications without robust clinical evidence.

Opportunities:

• Repurposing ARTANE for new neurological indications, contingent on successful clinical trials.
• Growing prevalence of neurodegenerative diseases, especially among aging populations, expanding projected demand.

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Market Projections

Future Demand Forecast

Analysis indicates that the global ARTANE market could grow modestly from USD 350 million in 2023 to approximately USD 480 million by 2030, representing a CAGR of roughly 4.3%. Several factors drive this:

• Aging demographics increasing Parkinson’s prevalence.
• Clinical trial developments supporting expanded indications.
• Broader acceptance of older anticholinergic therapies in supplementary roles.

Potential Impact of Repurposing and New Indications

Success in ongoing clinical trials for conditions like Alzheimer’s-related cognitive impairment or tardive dyskinesia could significantly alter market dynamics. An improved safety profile and clear efficacy could facilitate label expansions, leading to increased prescribing and higher revenues, potentially doubling market size within a decade.

Regulatory Outlook

Regulatory bodies have historically approved ARTANE for Parkinson’s management. The positive trajectory of clinical research favors potential approvals for additional indications. Nonetheless, safety concerns, particularly cognitive side effects, may complicate regulatory pathways, necessitating careful stratification of patient populations.

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Key Takeaways

• ARTANE's core market remains Parkinson’s disease management, with stable demand driven by aging populations.
• Ongoing clinical trials targeting neurodegenerative and movement disorders may unlock expanded therapeutic applications.
• Competitive pressures from generics and novel therapies underpin the necessity for strategic differentiation via clinical validation.
• Market growth prospects are moderate but promising, contingent upon successful clinical trials and regulatory approvals.
• Stakeholders should monitor emerging trial data closely, as successful repurposing could significantly uplift ARTANE’s market potential.

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FAQs

1. What are the main new clinical trials for ARTANE in development?
Current trials focus on its potential in Alzheimer’s disease, tardive dyskinesia, and post-stroke motor recovery, aiming to expand its therapeutic indications.

2. How does ARTANE compare to newer Parkinson’s treatments?
While effective in symptom management, ARTANE’s side effect profile and the advent of newer agents with fewer cognitive effects may limit its appeal, prompting ongoing interest in clinical trial-driven repurposing.

3. What market factors could influence ARTANE’s growth outlook?
Demographic trends, clinical trial success, regulatory approvals, and competitive pressures from generics and innovative therapies will shape future demand.

4. Are there safety concerns associated with ARTANE’s expanded use?
Yes. Elderly populations are at heightened risk for cognitive impairment and anticholinergic side effects, which regulatory agencies monitor closely.

5. What strategic moves should pharmaceutical companies consider regarding ARTANE?
Investing in clinical research for new indications, strategic collaborations for development, and proactive regulatory engagement are essential to capitalize on its full potential.

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References

[1] GlobalData, "Neurodegenerative Disease Market Report 2022," 2022.
[2] ClinicalTrials.gov, "Search Results for ARTANE," 2023.
[3] Pharma Intelligence, "Parkinson’s Disease Therapeutic Market," 2023.
[4] U.S. FDA Label for ARTANE (Trihexyphenidyl).
[5] EvaluatePharma, "Anticholinergic Drug Market Analysis," 2022.

Note: Data points and projections are based on current market analyses and ongoing clinical trial information as of early 2023.