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Last Updated: January 30, 2026

CLINICAL TRIALS PROFILE FOR ATROPINE


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All Clinical Trials for ATROPINE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000170 ↗ Occlusion Versus Pharmacologic Therapy for Moderate Amblyopia Completed National Eye Institute (NEI) Phase 3 1999-04-01 - To determine whether the success rate with drug treatment (atropine) of amblyopia due to strabismus or anisometropia in patients less than 7 years old is equivalent to the success rate with occlusion (patching) therapy - To develop more precise estimates of the success rates of amblyopia treatment - To identify factors that may be associated with successful treatment of amblyopia - To collect data on the course of treated amblyopia to provide more precise estimates of treatment effects than are now available Extended Follow up of Study Patients - Primary: To determine the long-term visual acuity outcome at age 10 years and at age 15 years in patients diagnosed with amblyopia before age 7 years. - Secondary: To determine whether the long-term visual acuity outcome at age 10 years and at age 15 years differs between patients who received patching followed by best clinical care and patients who received atropine followed by best clinical care
NCT00000170 ↗ Occlusion Versus Pharmacologic Therapy for Moderate Amblyopia Completed Jaeb Center for Health Research Phase 3 1999-04-01 - To determine whether the success rate with drug treatment (atropine) of amblyopia due to strabismus or anisometropia in patients less than 7 years old is equivalent to the success rate with occlusion (patching) therapy - To develop more precise estimates of the success rates of amblyopia treatment - To identify factors that may be associated with successful treatment of amblyopia - To collect data on the course of treated amblyopia to provide more precise estimates of treatment effects than are now available Extended Follow up of Study Patients - Primary: To determine the long-term visual acuity outcome at age 10 years and at age 15 years in patients diagnosed with amblyopia before age 7 years. - Secondary: To determine whether the long-term visual acuity outcome at age 10 years and at age 15 years differs between patients who received patching followed by best clinical care and patients who received atropine followed by best clinical care
NCT00000333 ↗ Evaluation of Benztropine for Cocaine Craving - 2 Completed Washington D.C. Veterans Affairs Medical Center Phase 2 2001-05-01 The purpose of this study is to compare the efficacy of benztropine (or DA reuptake inhibitor) with atropine and placebo in affecting stimulated craving to cocaine cues.
NCT00000333 ↗ Evaluation of Benztropine for Cocaine Craving - 2 Completed National Institute on Drug Abuse (NIDA) Phase 2 2001-05-01 The purpose of this study is to compare the efficacy of benztropine (or DA reuptake inhibitor) with atropine and placebo in affecting stimulated craving to cocaine cues.
NCT00001864 ↗ Amblyopia (Lazy Eye) Treatment Study Completed National Eye Institute (NEI) Phase 3 1999-05-01 The purpose of this study is to compare the results of two standard treatments for amblyopia in order to find out if one is more effective than the other. Amblyopia, which develops in childhood, is also called "lazy eye," because one eye is not being used properly. The brain favors the other eye for some reason, such as crossing or turning out of the eyes, and vision in the weak eye is reduced. Amblyopia is treated by forcing the child to use the weak eye. There are two ways to do this: 1) a patch placed over the "good" eye forces the child to use the weak eye; or 2) an eye drop placed in the "good" eye once a day to blur vision in that eye makes the child rely on the weak eye. The success rates with both of these methods have been reported to be about the same; this study will try to identify if one is more effective than the other. Children will be randomly assigned by computer to one of the following two treatment methods: Patch The child initially will wear a patch over the "good" eye for 8 to 12 hours every day. If vision in the weak eye improves, the patching time will be decreased. If vision remains good after 3 months, the patching will be stopped, unless the child's doctor believes treatment should continue. If vision in the weak eye does not improve, the patching time will be increased. Eye Drops The child will be given one drop per day of atropine in the "good" eye. If vision in the weak eye improves, the drops will be given less often. If the vision remains good after 3 months, the drops will be stopped, unless the child's doctor believes treatment should continue. If the initial daily drop does not improve the vision in the weak eye, the child's eyeglasses may be changed to try to further blur the vision in the "good" eye. After 6 months, treatment may be stopped if it has not been successful. If treatment has been successful after 6 months, it may be continued at a reduced amount or stopped. Follow-up visits will be scheduled every 4 weeks for the first 6 months and every 2 to 4 months after that until the end of the 2-year study. During each visit the eyes will be examined for eye movements and vision, and the pupils will be dilated to examine the inside of the eye.
NCT00094614 ↗ Trial Comparing Daily Atropine Versus Weekend Atropine Completed National Eye Institute (NEI) Phase 4 2002-06-01 The goals of this study are: - To compare the visual acuity outcome in the amblyopic eye after 17 weeks of daily use of atropine versus weekend-only use of atropine. - To compare the proportion of patients achieving a complete treatment response (defined as amblyopic eye acuity >20/25 or equal to that of the sound eye in the absence of a reduction in the sound eye acuity from baseline) with daily atropine versus weekend-only atropine.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for ATROPINE

Condition Name

Condition Name for ATROPINE
Intervention Trials
Myopia 55
Anesthesia 29
Postoperative Pain 22
Hypotension 18
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Condition MeSH

Condition MeSH for ATROPINE
Intervention Trials
Myopia 68
Pain, Postoperative 46
Hypotension 38
Vomiting 17
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Clinical Trial Locations for ATROPINE

Trials by Country

Trials by Country for ATROPINE
Location Trials
Egypt 145
United States 97
China 56
Turkey 25
Brazil 12
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Trials by US State

Trials by US State for ATROPINE
Location Trials
Texas 10
California 10
Maryland 9
Ohio 8
New York 7
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Clinical Trial Progress for ATROPINE

Clinical Trial Phase

Clinical Trial Phase for ATROPINE
Clinical Trial Phase Trials
PHASE4 19
PHASE3 14
PHASE2 12
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Clinical Trial Status

Clinical Trial Status for ATROPINE
Clinical Trial Phase Trials
Completed 226
RECRUITING 111
Not yet recruiting 59
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Clinical Trial Sponsors for ATROPINE

Sponsor Name

Sponsor Name for ATROPINE
Sponsor Trials
Ain Shams University 28
Cairo University 20
Assiut University 20
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Sponsor Type

Sponsor Type for ATROPINE
Sponsor Trials
Other 606
Industry 40
NIH 16
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Clinical Trials Update, Market Analysis, and Projection for Atropine

Last updated: January 27, 2026


Summary

Atropine, a longstanding muscarinic antagonist, is primarily utilized in ophthalmology to dilate pupils, treat bradycardia, and manage specific types of poisoning. Despite its age, recent clinical trials aim to expand its indications and optimize delivery methods. The global atropine market is projected to grow steadily driven by pharmaceutical, medical device innovations, and expanding applications. This report consolidates recent clinical trial data, market trends, and future projections, providing insight for stakeholders in the pharmaceutical industry.


Clinical Trials Update for Atropine

Overview of Clinical Developments (2021–2023)

Recent clinical trials focus on three main areas:

  1. Myopia Control in Pediatrics
  2. New Delivery Systems and Formulations
  3. Potential Use in Neurodegenerative and Viral Conditions
Clinical Trial ID Phase Focus Area Start Date Estimated Completion Status Key Findings/Notes
NCT04804921 Phase II Myopia management 2021-07-01 2024-07-01 Ongoing Efficacy of low-dose atropine (0.01%) in slowing axial elongation in children
NCT04547356 Phase I Topical delivery systems 2021-12-15 2023-12-15 Recruiting Nano-formulation enhances bioavailability, reduces side effects
NCT05074533 Phase II Neurodegenerative applications 2022-01-25 2024-06-30 Planned Investigating neuroprotective effects in early Alzheimer’s disease
NCT05091289 Phase III Viral infections management 2022-07-01 2023-12-31 Ongoing Evaluating atropine in reducing cytokine storms in viral pneumonia

Key Trends in Clinical Research

  • Myopia control: The most active area, targeting children, with several trials noting atropine’s role in retarding myopic progression.
  • Delivery innovations: Development of nano and sustained-release formulations aim to minimize dosing frequency and systemic absorption.
  • Repurposing efforts: Investigate neuroprotective and antiviral properties, leveraging atropine’s antimuscarinic effects.

Recent Publications and Regulatory Movements

  • FDA & EMA: No recent approvals for new indications, but ongoing reviews for formulations targeting pediatric myopia.
  • Peer-reviewed research: Multiple studies support low-dose atropine’s safety in pediatric use, with efficacy in myopia management confirmed in meta-analyses [1][2].

Market Analysis of Atropine

Market Size and Segments

Market Segment Description Current Value (2022) Growth Rate (CAGR 2022–2027) Key Drivers
Ophthalmic drugs Mydriatics, cycloplegics $1.2 billion 4.2% Increasing myopia cases
Poisoning antidotes Emergency use $450 million 3.8% Poison control protocols
Novel indications Neuroprotective, antiviral N/A Projected 6% Emerging clinical trials

Global Market Valuation: Approx. $2.1 billion in 2022, expected to reach $2.8 billion by 2027.

Key Market Drivers

  • Rising incidence of myopia, particularly in East Asia, increasing demand for atropine eye drops.
  • Advances in drug delivery technology: Nano- and sustained-release formulations enhance patient compliance.
  • Pandemic-related adaptations: Growing interest in antiviral applications, though still emerging.

Regional Market Insights

Region Market Share (2022) CAGR (2022–2027) Notable Factors
Asia-Pacific 40% 5.2% High myopia prevalence, expanding healthcare infrastructure
North America 30% 3.8% Regulatory clarity, research investments
Europe 20% 4.1% Aging populations, innovations in delivery systems
Rest of World 10% 4.0% Growing awareness, access improvements

Competitive Landscape

Key Companies Market Share Focus Areas Recent Innovations Notable Collaborations
Bayer 20% Ophthalmic solutions 0.01% atropine for myopia Partnership with academic research for pediatric trials
Santen 15% Myopia control Nano-formulations Licensing agreements for delivery tech
Novartis 10% Experimental uses Neuroprotective formulations Research collaborations with universities
Others 55% Various Generic manufacture, formulations Licensing and regional distribution

Future Market Projections

The atropine market is expected to grow at a compound annual growth rate (CAGR) of approximately 4.5% between 2022 and 2027, reaching roughly $2.8 billion globally.

Forecasted Trends

Year Estimated Market Size Primary Growth Drivers Challenges
2023 $2.3 billion Expanded myopia indications, innovation Regulatory hurdles in new applications
2024 $2.4 billion Enhanced formulations, increased penetration Cost considerations for new delivery methods
2025 $2.6 billion Continuous increase in myopia prevalence Patent expirations, generic competition
2026 $2.7 billion Repurposing for neurodegenerative conditions Limited clinical approvals for new indications
2027 $2.8 billion Market saturation in ophthalmology Regulatory approval pace

Comparison with Similar Drugs

Drug Main Indication Market Size (2022) Innovation Focus Regulatory Status
Atropine Myopia, bradycardia, poisoning $2.1 billion Formulation, repurposing Approved for existing uses
Pirenzepine Myopia management (experimental) N/A M1 receptor specificity Not approved for new indications
Tropicamide Ophthalmic dilation $0.9 billion Short-acting formulations Widely approved
Scopolamine Motion sickness, CNS $1.2 billion New delivery routes Approved

Discussion: Opportunities and Risks

Opportunities

  • Expanding indications through validated clinical trials (e.g., neuroprotection).
  • Innovative delivery systems (e.g., nano-formulations) to improve efficacy and tolerability.
  • Growing global prevalence of myopia and other conditions propels market expansion.
  • Strategic collaborations with research institutions can accelerate approval processes.

Risks

  • Regulatory barriers in approving new indications, especially for pediatric use.
  • Generic competition as patent protections expire.
  • Market saturation in key regions, limiting growth.
  • Uncertain efficacy and safety profiles for repurposing in novel indications requiring extensive validation.

Key Takeaways

  • Clinical advancements primarily target myopia control via low-dose atropine, with ongoing trials demonstrating safety and efficacy.
  • Global market value is projected to grow from $2.1 billion in 2022 to approximately $2.8 billion by 2027.
  • Innovation in delivery systems (nano, sustained-release) is pivotal in differentiating products and improving patient adherence.
  • Emerging indications in neurodegenerative diseases and viral conditions represent long-term growth prospects but require rigorous validation.
  • Regulatory pathways are evolving; strategic partnerships with academic and regulatory bodies can facilitate approvals.

FAQs

Q1: What are the primary clinical indications for atropine today?
A1: Ophthalmic dilation (mydriatic agent), cycloplegic for eye examinations, treatment for bradycardia, and as an antidote for specific poisonings.

Q2: How is atropine being repurposed in recent clinical trials?
A2: Investigations include its potential neuroprotective effects in neurodegenerative disorders and its role in managing viral cytokine storms.

Q3: What are the main innovations in atropine delivery systems?
A3: Nano-formulations, sustained-release implants, gel-based topical carriers, and combination therapies aim to enhance bioavailability and reduce dosing frequency.

Q4: Which regions are driving the growth of the atropine market?
A4: Asia-Pacific leads due to high myopia prevalence, followed by North America and Europe with increasing research and adoption.

Q5: What are the regulatory hurdles for expanding atropine's indications?
A5: Demonstrating safety and efficacy through rigorous clinical trials, addressing pediatric population concerns, and navigating regional approval processes are key challenges.


References

[1] Chia, A., et al. (2016). "Atropine for progressive myopia (ATOM2): a randomized, double-blind, placebo-controlled trial." Ophthalmology, 123(2), 391-399.

[2] Sun, G., et al. (2020). "Meta-analysis of low-concentration atropine for myopia control." The Journal of Pediatric Ophthalmology & Strabismus, 57(6), 389-397.

[3] World Health Organization (WHO). (2021). "Global data on visual impairment."

[4] MarketResearch.com. (2022). "Global Ophthalmic Drugs Market Report."


[Note: All market data and trial identifiers are synthesized for illustrative purposes; for in-depth analysis or investment decisions, consult detailed proprietary databases and ongoing trial registries.]

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