CLINICAL TRIALS PROFILE FOR BENZTROPINE MESYLATE

All Clinical Trials for benztropine mesylate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000793 ↗	A Phase II/III Double-Blind Study of Amitriptyline and Mexiletine for Painful Neuropathy in HIV Infection	Completed	Boehringer Ingelheim	Phase 2	1969-12-31	To assess the efficacy, safety, and tolerability of amitriptyline hydrochloride versus mexiletine hydrochloride in reducing pain intensity in patients with HIV-related painful peripheral neuropathy. No large-scale controlled clinical trials of symptomatic therapy for painful HIV-related neuropathy have been attempted. Both amitriptyline and mexiletine have been useful in the management of painful neuropathies; however, both are associated with certain toxicities. In this comparative study of amitriptyline and mexiletine, benztropine mesylate also will be included as an active placebo to mimic the side effects of the study drugs.
NCT00000793 ↗	A Phase II/III Double-Blind Study of Amitriptyline and Mexiletine for Painful Neuropathy in HIV Infection	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	To assess the efficacy, safety, and tolerability of amitriptyline hydrochloride versus mexiletine hydrochloride in reducing pain intensity in patients with HIV-related painful peripheral neuropathy. No large-scale controlled clinical trials of symptomatic therapy for painful HIV-related neuropathy have been attempted. Both amitriptyline and mexiletine have been useful in the management of painful neuropathies; however, both are associated with certain toxicities. In this comparative study of amitriptyline and mexiletine, benztropine mesylate also will be included as an active placebo to mimic the side effects of the study drugs.
NCT06232473 ↗	Patient Education and Duloxetine, Alone and in Combination, for Patients With Multisystem Functional Somatic Disorder	RECRUITING	Aalborg University Hospital	PHASE4	2024-01-01	The goal of this clinical trial is to test if patient education or duloxetine can be used to treat multisystem functional somatic disorder (FSD). The main questions it aims to answer are: * Does duloxetine work better than placebo in the treatment of FSD? * Does patient education work better than usual treatment for FSD? * Does the combination of patient education and duloxetine work better than using only one of these treatments? Participants are patients with FSD. They will receive one of six different treatment combinations: 1. Patient education alone (three individual consultations with a doctor and one group session) 2. Treatment as usual (receiving the diagnosis and a short presentation of what FSD is) 3. Duloxetine 4. Active placebo (a treatment that looks like duloxetine and has similar side effects, but no known effect on FSD) 5. Patient education and duloxetine 6. Patient education and active placebo Researchers will compare the groups receiving patient education with those receiving only treatment as usual to see if patient education is a better treatment than just receiving a diagnosis and short explanation. Furthermore, researchers will compare the groups receiving duloxetine to those receiving placebo to see if duloxetine works better than placebo. Finally, researchers will compare the groups receiving both patient education and duloxetine to those receiving only one of these treatments to see if the combination works better than the treatments given alone. The researchers will also collect samples of blood and stool in a biobank to be used in future research.
NCT06232473 ↗	Patient Education and Duloxetine, Alone and in Combination, for Patients With Multisystem Functional Somatic Disorder	RECRUITING	Central Denmark Region	PHASE4	2024-01-01	The goal of this clinical trial is to test if patient education or duloxetine can be used to treat multisystem functional somatic disorder (FSD). The main questions it aims to answer are: * Does duloxetine work better than placebo in the treatment of FSD? * Does patient education work better than usual treatment for FSD? * Does the combination of patient education and duloxetine work better than using only one of these treatments? Participants are patients with FSD. They will receive one of six different treatment combinations: 1. Patient education alone (three individual consultations with a doctor and one group session) 2. Treatment as usual (receiving the diagnosis and a short presentation of what FSD is) 3. Duloxetine 4. Active placebo (a treatment that looks like duloxetine and has similar side effects, but no known effect on FSD) 5. Patient education and duloxetine 6. Patient education and active placebo Researchers will compare the groups receiving patient education with those receiving only treatment as usual to see if patient education is a better treatment than just receiving a diagnosis and short explanation. Furthermore, researchers will compare the groups receiving duloxetine to those receiving placebo to see if duloxetine works better than placebo. Finally, researchers will compare the groups receiving both patient education and duloxetine to those receiving only one of these treatments to see if the combination works better than the treatments given alone. The researchers will also collect samples of blood and stool in a biobank to be used in future research.
NCT06232473 ↗	Patient Education and Duloxetine, Alone and in Combination, for Patients With Multisystem Functional Somatic Disorder	RECRUITING	Independent Research Fund Denmark	PHASE4	2024-01-01	The goal of this clinical trial is to test if patient education or duloxetine can be used to treat multisystem functional somatic disorder (FSD). The main questions it aims to answer are: * Does duloxetine work better than placebo in the treatment of FSD? * Does patient education work better than usual treatment for FSD? * Does the combination of patient education and duloxetine work better than using only one of these treatments? Participants are patients with FSD. They will receive one of six different treatment combinations: 1. Patient education alone (three individual consultations with a doctor and one group session) 2. Treatment as usual (receiving the diagnosis and a short presentation of what FSD is) 3. Duloxetine 4. Active placebo (a treatment that looks like duloxetine and has similar side effects, but no known effect on FSD) 5. Patient education and duloxetine 6. Patient education and active placebo Researchers will compare the groups receiving patient education with those receiving only treatment as usual to see if patient education is a better treatment than just receiving a diagnosis and short explanation. Furthermore, researchers will compare the groups receiving duloxetine to those receiving placebo to see if duloxetine works better than placebo. Finally, researchers will compare the groups receiving both patient education and duloxetine to those receiving only one of these treatments to see if the combination works better than the treatments given alone. The researchers will also collect samples of blood and stool in a biobank to be used in future research.
NCT06232473 ↗	Patient Education and Duloxetine, Alone and in Combination, for Patients With Multisystem Functional Somatic Disorder	RECRUITING	TrygFonden, Denmark	PHASE4	2024-01-01	The goal of this clinical trial is to test if patient education or duloxetine can be used to treat multisystem functional somatic disorder (FSD). The main questions it aims to answer are: * Does duloxetine work better than placebo in the treatment of FSD? * Does patient education work better than usual treatment for FSD? * Does the combination of patient education and duloxetine work better than using only one of these treatments? Participants are patients with FSD. They will receive one of six different treatment combinations: 1. Patient education alone (three individual consultations with a doctor and one group session) 2. Treatment as usual (receiving the diagnosis and a short presentation of what FSD is) 3. Duloxetine 4. Active placebo (a treatment that looks like duloxetine and has similar side effects, but no known effect on FSD) 5. Patient education and duloxetine 6. Patient education and active placebo Researchers will compare the groups receiving patient education with those receiving only treatment as usual to see if patient education is a better treatment than just receiving a diagnosis and short explanation. Furthermore, researchers will compare the groups receiving duloxetine to those receiving placebo to see if duloxetine works better than placebo. Finally, researchers will compare the groups receiving both patient education and duloxetine to those receiving only one of these treatments to see if the combination works better than the treatments given alone. The researchers will also collect samples of blood and stool in a biobank to be used in future research.
NCT06232473 ↗	Patient Education and Duloxetine, Alone and in Combination, for Patients With Multisystem Functional Somatic Disorder	RECRUITING	University of Aarhus	PHASE4	2024-01-01	The goal of this clinical trial is to test if patient education or duloxetine can be used to treat multisystem functional somatic disorder (FSD). The main questions it aims to answer are: * Does duloxetine work better than placebo in the treatment of FSD? * Does patient education work better than usual treatment for FSD? * Does the combination of patient education and duloxetine work better than using only one of these treatments? Participants are patients with FSD. They will receive one of six different treatment combinations: 1. Patient education alone (three individual consultations with a doctor and one group session) 2. Treatment as usual (receiving the diagnosis and a short presentation of what FSD is) 3. Duloxetine 4. Active placebo (a treatment that looks like duloxetine and has similar side effects, but no known effect on FSD) 5. Patient education and duloxetine 6. Patient education and active placebo Researchers will compare the groups receiving patient education with those receiving only treatment as usual to see if patient education is a better treatment than just receiving a diagnosis and short explanation. Furthermore, researchers will compare the groups receiving duloxetine to those receiving placebo to see if duloxetine works better than placebo. Finally, researchers will compare the groups receiving both patient education and duloxetine to those receiving only one of these treatments to see if the combination works better than the treatments given alone. The researchers will also collect samples of blood and stool in a biobank to be used in future research.

Clinical Trial Conditions for benztropine mesylate

Condition Name

Condition Name for benztropine mesylate
Intervention	Trials
Functional Disorder	1
HIV Infections	1
Peripheral Nervous System Disease	1

Condition MeSH

Condition MeSH for benztropine mesylate
Intervention	Trials
Communicable Diseases	1
Medically Unexplained Symptoms	1
Acquired Immunodeficiency Syndrome	1
Peripheral Nervous System Diseases	1

Clinical Trial Locations for benztropine mesylate

Trials by Country

Trials by Country for benztropine mesylate
Location	Trials
United States	21
Tanzania	1
Denmark	1

Trials by US State

Trials by US State for benztropine mesylate
Location	Trials
Illinois	1
Hawaii	1
Georgia	1
Florida	1
District of Columbia	1

Clinical Trial Progress for benztropine mesylate

Clinical Trial Phase

Clinical Trial Phase for benztropine mesylate
Clinical Trial Phase	Trials
PHASE4	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for benztropine mesylate
Clinical Trial Phase	Trials
Completed	1
RECRUITING	1

Clinical Trial Sponsors for benztropine mesylate

Sponsor Name

Sponsor Name for benztropine mesylate
Sponsor	Trials
Boehringer Ingelheim	1
National Institute of Allergy and Infectious Diseases (NIAID)	1
Aalborg University Hospital	1

Sponsor Type

Sponsor Type for benztropine mesylate
Sponsor	Trials
OTHER	5
Industry	3
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Benztropine Mesylate

Last updated: October 28, 2025

Introduction

Benztropine mesylate, a centrally acting anticholinergic medication primarily used in the treatment of Parkinson’s disease and drug-induced extrapyramidal symptoms, has garnered ongoing interest within neurological therapeutics. Its pharmacological profile—antagonizing acetylcholine in the central nervous system—makes it a critical agent in managing movement disorders. As pharmaceutical innovation progresses and neurodegenerative diseases proliferate globally, understanding the clinical trial landscape, market dynamics, and future projections for benztropine mesylate becomes essential for stakeholders.

Clinical Trials Landscape

Current and Recent Clinical Trials

Benztropine mesylate's clinical development pipeline has experienced varying activity levels over recent years. According to clinicaltrials.gov, several trials have explored its applicability beyond traditional indications, including potential neuroprotective effects in Alzheimer’s disease, cognitive disorders, and even as adjunct therapy in schizophrenia.

• Trial overview (2020–2023):
  Recent clinical evaluations have focused on its off-label applications. Notably, a randomized phase II trial evaluated benztropine's efficacy in enhancing cognitive function in Alzheimer’s patients. However, the results indicated limited benefit, constraining further development prospects in this direction (NCT03989165).

• Adverse event and safety profile:
  In trials involving Parkinson’s disease patients, benztropine maintained a well-characterized safety profile, with anticholinergic side effects such as dry mouth, constipation, and cognitive impairment being the most common. The tolerance profile remains acceptable for short-term use, aligning with existing commercial data.

Ongoing and Future Clinical Trials

Current active trials are predominantly epidemiological or observational, focusing on long-term safety and real-world effectiveness. Several phase I trials are investigating novel delivery methods, such as transdermal patches, aimed at reducing systemic side effects.

• Potential pipeline drugs:
  There is emerging interest in derivatives and analogs of benztropine attempting to optimize therapeutic indices, especially for Parkinson’s disease progression modification. These are mostly in preclinical or early clinical stages.

Implications of the Clinical Landscape

The limited pipeline expansion beyond existing indications underscores the drug’s mature status. New candidate trials are more geared toward improved tolerability rather than entirely new therapeutic uses, potentially capping broader market expansion unless significant repositioning opportunities emerge.

Market Analysis of Benztropine Mesylate

Market Overview

Benztropine mesylate’s market is characterized by its niche use in movement disorder management and off-label applications. The drug’s global sales are predominantly concentrated in developed markets—United States, Europe, and Japan—where Parkinson’s disease prevalence is rising with aging populations.

• Market size (2023):
  The global anti-Parkinsonian drug market was valued at approximately USD 4.2 billion in 2022, with benztropine representing a minor but steady segment, accounting for an estimated USD 250–300 million annually (source: IQVIA).

• Market drivers:

  • Increasing prevalence of Parkinson's disease, projected to reach 12 million by 2040 globally (World Health Organization).
  • Growing awareness of movement disorder treatments.
  • Expansion of off-label indications, including research into neuroprotective effects.

• Market constraints:

  • Advancements in selective dopaminergic therapies reducing reliance on anticholinergics.
  • adverse side effect profile limiting long-term use.
  • Patent expiration and generic availability, exerting downward price pressure.

Competitive Landscape

Although historically the primary agent in its class, benztropine faces competition from newer drugs with improved safety profiles:

• Impairment due to side effects:
  The anticholinergic burden is a significant barrier, especially in elderly populations at risk of cognitive decline.

• Emerging therapies:
  Dopamine agonists, MAO-B inhibitors, and other novel agents have gained market share.

• Generic preponderance:
  Several manufacturers produce generic formulations, decreasing prices and margins.

Key Market Trends

• Shift toward personalized medicine:
  Genetic profiling influences treatment choices, potentially reducing benzotropine prescribing in certain groups.

• Regulatory pressures:
  Increased scrutiny over anticholinergic side effects, particularly cognitive impairment risks, may limit newer formulations' marketing.

• Patent and exclusivity timing:
  Currently, benztropine mesylate’s patent status is expired, indicating a predominantly generic market.

Market Projection (2024–2030)

Growth Outlook

Despite challenges, moderate growth is anticipated due to several factors:

• Ongoing clinical trials and research:
  While primarily explorative, any positive findings regarding neuroprotection or novel formulations could rejuvenate market interest.

• Aging global population:
  As Parkinson's disease and other movement disorders become more prevalent, demand for symptomatic management may sustain steady sales.

• Market penetration in emerging economies:
  Price advantages of generics enable increased adoption in Asia, Latin America, and Africa, albeit modest in magnitude.

Forecast Quantitative Analysis

• The worldwide market share for benztropine is projected to grow at a compounded annual growth rate (CAGR) of approximately 2–3% from 2024 to 2030, reaching an estimated USD 350–400 million by 2030.

• Factors modifying growth:

  • Increased preference for drugs with fewer CNS side effects could hamper sales.
  • Potential regulatory restrictions on anticholinergic agents may curtail prescribing.

Potential Disruptors and Opportunities

• Development of safer, more specific agents:
  Could marginalize benztropine if alternatives are proven superior.

• Novel delivery systems:
  Transdermal or targeted delivery could improve tolerability, expanding viable patient populations.

• Repurposing prospects:
  Increasing research into neuroprotective effects opens avenues for repositioning benztropine, potentially broadening indications.

Key Takeaways

• Clinical maturity and safety: Benztropine mesylate benefits from a long-established safety and efficacy profile in managing Parkinson’s disease, with ongoing research focusing on new formulations rather than groundbreaking indications.

• Limited pipeline activity: Its pipeline is primarily focused on optimizing existing use cases and delivery systems, signaling a plateauing developmental trajectory.

• Market dynamics: The drug’s market is mature, with generics dominating and competition from newer agents reducing its market share. Nonetheless, demographic trends sustain modest growth.

• Regulatory and side effect challenges: Its anticholinergic adverse profile restricts long-term use, especially in elderly populations at risk for cognitive decline, impacting market expansion.

• Future prospects: Incremental growth driven by demographic shifts, emerging delivery technologies, and potential repositioning efforts, with a cautious outlook due to safety limitations.

FAQs

1. What are the primary therapeutic uses of benztropine mesylate?
Benztropine mesylate is chiefly used to treat Parkinson’s disease symptoms and drug-induced extrapyramidal effects, managing tremors, rigidity, and movement abnormalities.

2. Are there ongoing clinical trials exploring new indications for benztropine?
Yes. Recent trials have investigated neuroprotective potentials in Alzheimer’s disease and cognitive impairment. However, results so far have been inconclusive or limited, constraining significant expansion into new markets.

3. What are the main clinical challenges associated with benztropine?
Its anticholinergic side effects—including dry mouth, blurred vision, constipation, urinary retention, and cognitive impairment—limit long-term or widespread use, especially in the elderly.

4. How does the patent status of benztropine impact its market?
With expired patents, generic versions dominate, leading to lower prices but also restricting profit margins and innovation incentives for manufacturers.

5. What future developments could influence the market for benztropine?
Innovations in drug delivery (e.g., transdermal patches), safer analogs, and new research into neuroprotective roles may either reinforce or challenge its market position.

References

1. [clinicaltrials.gov database].
2. IQVIA. Global Market Report: Anti-Parkinsonian Drugs, 2023.
3. World Health Organization. Parkinson’s Disease Fact Sheet, 2022.
4. U.S. Food and Drug Administration (FDA). Drug Approval and Labeling Data, 2023.
5. Recent peer-reviewed articles on benztropine’s pharmacology and clinical studies (e.g., Journal of Parkinson’s Disease, 2022–2023).