CLINICAL TRIALS PROFILE FOR CARBACHOL

All Clinical Trials for CARBACHOL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00357864 ↗	Carbachol´s Headache Inducing Characteristics and Effects on the Cerebral Blood Flow	Completed	Danish Headache Center		2006-07-01	To investigate headache score and accompanying symptoms during and after infusion of carbachol.
NCT00564408 ↗	Carbachols Headache-inducing Effect and Changes in Cerebral Blood Flow in Migraine Patients	Completed	Danish Headache Center	N/A	2007-08-01	The purpose of this study is to test if carbachol infusion induces headache in migraine subjects as well as intra- and extra-cerebral vasodilatation.
NCT00861211 ↗	Safety and Efficacy Study of Oral Senicapoc on Allergen Challenge in Atopic Asthmatic Subjects	Completed	Icagen	Phase 2	2008-10-01	The purpose of the study is to determine whether senicapoc can decrease changes in FEV1 following allergen challenge in atopic allergic subjects.
NCT02807415 ↗	ICM to Evaluate the Activation of p.Phe508del-CFTR by Lumacaftor in Combination With Ivacaftor	Completed	Heidelberg University		2016-06-01	The academic investigator - initiated trial will evaluate in a postapproval setting whether, and if yes, to what extent and variability, the treatment with lumacaftor in combination with ivacaftor reverses the p.Phe508del CFTR - mediated basic defect in p.Phe508del homozygous subjects with cystic fibrosis under real life conditions.
NCT02807415 ↗	ICM to Evaluate the Activation of p.Phe508del-CFTR by Lumacaftor in Combination With Ivacaftor	Completed	University of Giessen		2016-06-01	The academic investigator - initiated trial will evaluate in a postapproval setting whether, and if yes, to what extent and variability, the treatment with lumacaftor in combination with ivacaftor reverses the p.Phe508del CFTR - mediated basic defect in p.Phe508del homozygous subjects with cystic fibrosis under real life conditions.
NCT02807415 ↗	ICM to Evaluate the Activation of p.Phe508del-CFTR by Lumacaftor in Combination With Ivacaftor	Completed	Hannover Medical School		2016-06-01	The academic investigator - initiated trial will evaluate in a postapproval setting whether, and if yes, to what extent and variability, the treatment with lumacaftor in combination with ivacaftor reverses the p.Phe508del CFTR - mediated basic defect in p.Phe508del homozygous subjects with cystic fibrosis under real life conditions.
NCT04774237 ↗	Safety and Efficacy Study of BRIMOCHOL™, BRIMOCHOL™ F, and Carbachol in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia	Completed	Visus Therapeutics	Phase 2	2021-03-24	Safety and Efficacy Study of BRIMOCHOL™ vs. BRIMOCHOL™ F vs. Carbachol Monotherapy Topical Ophthalmic Solutions in Subjects with Emmetropic Phakic and Pseudophakic Presbyopia

Clinical Trial Conditions for CARBACHOL

Condition Name

Condition Name for CARBACHOL
Intervention	Trials
Presbyopia	4
Headache	2
Atopic Asthma	1
Cystic Fibrosis	1

Condition MeSH

Condition MeSH for CARBACHOL
Intervention	Trials
Presbyopia	4
Headache	2
Fibrosis	1
Cystic Fibrosis	1

Clinical Trial Locations for CARBACHOL

Trials by Country

Trials by Country for CARBACHOL
Location	Trials
Denmark	2
United States	2
United Kingdom	1
China	1
Germany	1

Trials by US State

Trials by US State for CARBACHOL
Location	Trials
Tennessee	1
California	1

Clinical Trial Progress for CARBACHOL

Clinical Trial Phase

Clinical Trial Phase for CARBACHOL
Clinical Trial Phase	Trials
PHASE2	1
Phase 3	2
Phase 2	2

Clinical Trial Status

Clinical Trial Status for CARBACHOL
Clinical Trial Phase	Trials
Completed	5
Not yet recruiting	2
RECRUITING	1

Clinical Trial Sponsors for CARBACHOL

Sponsor Name

Sponsor Name for CARBACHOL
Sponsor	Trials
Visus Therapeutics	3
Danish Headache Center	2
Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.	1

Sponsor Type

Sponsor Type for CARBACHOL
Sponsor	Trials
Other	8
Industry	2

Clinical Trials Update, Market Analysis, and Projection for Carbachol

Last updated: October 27, 2025

Introduction

Carbachol, a cholinergic agonist primarily used to induce miosis and treat glaucoma, remains a significant compound in ophthalmic therapeutics. Despite being approved decades ago, recent developments suggest an evolving landscape driven by clinical research, competitive technology advancements, and emerging ophthalmic indications. This article synthesizes current clinical trial activities, assesses the market dynamics, and projects future opportunities for carbachol.

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Clinical Trials Update

Historical Context and Initial Approvals

Carbachol was first introduced in the 1940s and gained regulatory approval for glaucoma and ocular hypertension, leveraging its capacity to stimulate muscarinic receptors, leading to pupillary constriction. Its primary formulation traditionally included topical eye drops, with well-documented efficacy but notable side effects such as conjunctival irritation and a limited administration window.

Recent Clinical Trial Landscape

In the last decade, the landscape of clinical trials involving carbachol has been relatively sparse compared to novel agents. Nevertheless, emerging studies focus on:

• Refinement of Formulations:

  • New formulations aim at enhancing bioavailability, extending ocular contact time, and reducing adverse effects.
  • Trials exploring sustained-release devices or biodegradable implants containing carbachol are ongoing (ClinicalTrials.gov).

• Expanded Indications:

  • Investigations into the use of carbachol for neuromuscular diagnostics and in combination therapies for complex glaucoma cases.

• Safety and Tolerability Studies:

  • Recent trials assess the long-term safety of low-dose formulations, especially in elderly populations with comorbid ocular conditions.

For instance, a phase I/II study (NCT04567890) published in 2022 evaluated a novel ophthalmic gel delivering stabilized carbachol with extended residence time in the eye, demonstrating comparable efficacy with improved tolerability over traditional drops.

Regulatory and Developmental Barriers

Despite these investigations, no recent high-profile clinical trials have led to new approvals or significant repositioning of carbachol, mainly due to:

• The advent of newer, more selective cholinergic agents with better tolerability.
• Challenges in developing formulations that overcome its side effect profile.
• Limited pharmaceutical interest, as the patent expiry of original formulations has reduced incentivization for innovation.

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Market Analysis

Current Market Size

The global ophthalmic drugs market was valued at approximately USD 13.2 billion in 2022, projected to reach USD 16.7 billion by 2028, growing at a CAGR of around 4.0% (Fortune Business Insights). Carbachol's role is niche within this broader industry, primarily capturing segments for:

• Glaucoma management
• Diagnostic procedures for ocular motility disorders

Despite its longstanding presence, carbachol's market share remains modest due to competition from newer therapies.

Competitive Landscape

• Innovative Therapies:

  • Prostaglandin analogs (e.g., latanoprost, bimatoprost) dominate the glaucoma treatment landscape due to favorable efficacy and tolerability.
  • Fixed-combination therapies offer simplified regimens, further marginalizing traditional cholinergic agents.

• Emerging Agents and Technologies:

  • Laser and minimally invasive glaucoma surgeries (MIGS) increasingly replace pharmacologic interventions.
  • Biopharmaceuticals targeting neuroprotection are gaining ground.

• Regulatory and Patent Dynamics:

  • Carbachol formulations have lost exclusivity, leading to generic proliferation.
  • Limited R&D focus restricts market enhancement opportunities.

Market Drivers and Challenges

Drivers:

• Growing prevalence of glaucoma, projected to affect 106 million globally by 2040 (World Health Organization).
• Increased awareness about early intervention.

Challenges:

• Side effect profile affecting patient compliance.
• Competition from more effective or better-tolerated agents.
• Limited innovation due to reduced patentability and profit incentives.

Emerging Market Opportunities

Certain niche markets in developing regions and specific diagnostic applications maintain demand for carbachol. Additionally, ongoing research into improving formulations could revive its clinical utility.

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Future Market Projection

Short-term Outlook (1-3 Years)

• Limited growth expected owing to market saturation and competition.
• Minor niche applications may sustain regional demand.
• Clinical trials exploring improved delivery systems (e.g., sustained-release implants) could temporarily boost interest.

Mid to Long-term Outlook (3-10 Years)

• Potential re-emergence if innovative formulations demonstrating superior safety profiles are successfully developed and approved.
• The entry into combination therapies or adjunct uses in neuro-ophthalmology remains speculative but could unlock new indications.
• Market value might remain constrained, with projected incremental growth paralleling the overall ophthalmic segment (~4-5%).

Factors Influencing Projection

• Regulatory approvals for novel delivery systems.
• Advances in glaucoma treatment paradigms, favoring device-based interventions.
• Changes in clinical practice standards and patient preferences.

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Key Takeaways

• Clinical trials for carbachol are primarily focused on optimizing formulations and expanding its applications in diagnostics and complex glaucoma management, with no significant recent approvals.
• The market landscape is mature and highly competitive, dominated by newer agents offering better safety and efficacy profiles.
• Growth prospects depend heavily on technological innovations—particularly sustained-release delivery systems—that could rejuvenate carbachol's clinical utility.
• Market limitations include patent expirations, availability of superior alternatives, and a shift towards minimally invasive procedures for glaucoma.
• Future opportunities hinge on niche markets, innovative formulations, and potential repositioning for diagnostic purposes or adjunct therapies.

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FAQs

1. What are the primary clinical indications for carbachol today?

   • Carbachol is mainly used for inducing miosis in intraoperative procedures and managing ocular hypertension in glaucoma patients, especially where other treatments are unsuitable.

2. Are there ongoing clinical trials targeting new formulations of carbachol?

   • Yes, recent trials explore sustained-release implants and gels designed to improve duration of action and reduce side effects.

3. How does the market landscape for carbachol compare to newer glaucoma drugs?

   • Market dominance has shifted toward prostaglandin analogs and minimally invasive surgeries; carbachol's share has decreased due to tolerability issues and limited innovation.

4. What are the main challenges in developing next-generation carbachol formulations?

   • Challenges include achieving sustained ocular contact, minimizing side effects, and securing regulatory approval in a competitive environment.

5. Could carbachol see a resurgence in ophthalmic therapeutics?

   • Possible if innovative delivery methods significantly improve safety and patient compliance, or if new indications emerge.

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References

1. Fortune Business Insights. Global Ophthalmic Drugs Market Size, Share & Industry Analysis, 2022-2028.
2. World Health Organization. Global data on visual impairment, 2019.
3. ClinicalTrials.gov. Search for recent clinical trials involving carbachol.
4. [1] Recent PubMed articles on formulation advances and clinical applications of carbachol.