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Last Updated: March 18, 2025

CLINICAL TRIALS PROFILE FOR URECHOLINE


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All Clinical Trials for URECHOLINE

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT01031043 ↗ Topical Bethanechol for Improvement of Esophageal Dysmotility Completed Augusta University Phase 1 2009-11-01 The purpose of this research project is to determine the effect of a drug called bethanechol on swallowing function in patients with Ineffective Esophageal Motility (IEM). This drug is FDA approved for use in treating other conditions, but not for the treatment of IEM. There is currently no approved therapy for the treatment of IEM. This information is important for the possible development of new ways of treating patients with IEM and for the effectiveness of topically applied Bethanechol on patients with IEM.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 1 of 1 entries

Clinical Trial Conditions for URECHOLINE

Condition Name

10-0.100.10.20.30.40.50.60.70.80.911.1Esophageal Dysmotility[disabled in preview]
Condition Name for URECHOLINE
Intervention Trials
Esophageal Dysmotility 1
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Condition MeSH

110-0.100.10.20.30.40.50.60.70.80.911.1Esophageal Spasm, DiffuseEsophageal Motility Disorders[disabled in preview]
Condition MeSH for URECHOLINE
Intervention Trials
Esophageal Spasm, Diffuse 1
Esophageal Motility Disorders 1
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Clinical Trial Locations for URECHOLINE

Trials by Country

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Trials by Country for URECHOLINE
Location Trials
United States 1
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Trials by US State

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Trials by US State for URECHOLINE
Location Trials
Georgia 1
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Clinical Trial Progress for URECHOLINE

Clinical Trial Phase

100.0%0-0.100.10.20.30.40.50.60.70.80.911.1Phase 1[disabled in preview]
Clinical Trial Phase for URECHOLINE
Clinical Trial Phase Trials
Phase 1 1
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Clinical Trial Status

100.0%0-0.100.10.20.30.40.50.60.70.80.911.1Completed[disabled in preview]
Clinical Trial Status for URECHOLINE
Clinical Trial Phase Trials
Completed 1
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Clinical Trial Sponsors for URECHOLINE

Sponsor Name

trials000001111111Augusta University[disabled in preview]
Sponsor Name for URECHOLINE
Sponsor Trials
Augusta University 1
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Sponsor Type

100.0%0-0.100.10.20.30.40.50.60.70.80.911.1Other[disabled in preview]
Sponsor Type for URECHOLINE
Sponsor Trials
Other 1
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Clinical Trials, Market Analysis, and Projections for Urecholine (Bethanechol Chloride)

Introduction

Urecholine, also known as bethanechol chloride, is a cholinergic agonist used primarily for the treatment of acute postoperative and postpartum nonobstructive urinary retention, as well as neurogenic atony of the urinary bladder. This article will delve into recent clinical trials, market analysis, and future projections for Urecholine.

Clinical Trials and Efficacy

Historical Studies

Historical clinical studies have established the efficacy of Urecholine in treating urinary retention. A notable study by Diokno and Lapides in 1977 compared the effectiveness of oral and subcutaneous doses of bethanechol chloride on the stretch response of bladder muscle in patients with urinary retention. The study found that subcutaneous doses produced a more rapid and intense response, while oral doses had a longer duration of effect[5].

Current Clinical Context

While there are no recent large-scale clinical trials specifically focused on Urecholine, its continued use and preference among healthcare professionals are indicative of its established efficacy. A survey involving urologists across various regions highlighted that bethanechol remains the preferred drug for managing postoperative urinary retention and other pathologies causing underactive bladder[4].

Market Analysis

Current Market Size

The global market for bethanechol was estimated to be worth $2.125 billion in 2023. This market is part of the broader pharmaceutical industry, which is driven by increasing R&D investments and a growing pipeline of drug candidates[2].

Market Projections

The bethanechol market is forecasted to grow to $3.048 billion by 2030, with a Compound Annual Growth Rate (CAGR) of 5.3% during the forecast period of 2024-2030. This growth is attributed to the increasing prevalence of conditions such as benign prostatic hyperplasia, diabetic neuropathy, and neurological diseases, which require the use of bethanechol[2].

Key Players

The market for bethanechol is dominated by several key players, including Amneal Pharm, Eci Pharms, Heritage Pharma, Lannett, Upsher Smith Labs, and Wockhardt, among others. These companies are focusing on improving drug delivery systems, such as sustained-release tablets, to enhance compliance, safety, and efficacy[2].

Market Trends

Increasing Demand for Effective Treatments

The demand for effective treatments for urinary retention and related conditions is on the rise, driven by an aging population and the increasing prevalence of chronic diseases. This trend is expected to continue, supporting the growth of the bethanechol market[4].

Advancements in Drug Delivery

Healthcare professionals are increasingly looking for improved drug delivery systems, such as sustained-release tablets, which can enhance patient compliance and reduce side effects. This trend is likely to influence the development and marketing strategies of key players in the bethanechol market[4].

Regulatory Environment

Favorable regulatory environments and ongoing improvements in regulatory procedures, particularly in regions like the Asia Pacific, are expected to support the growth of the clinical trials and pharmaceutical markets, including the segment for bethanechol[3].

Regional Analysis

Asia Pacific

The Asia Pacific region is emerging as a significant market for clinical trials and pharmaceuticals, including bethanechol. The region offers cost benefits, a large treatment population, and improving regulatory environments, making it an attractive destination for pharmaceutical and biotechnology companies[3].

Challenges and Opportunities

Challenges

Despite the growth potential, the bethanechol market faces challenges such as the availability of alternative treatments and the need for continuous innovation to stay competitive. Additionally, the shortage of skilled professionals in clinical trials could impact the development and approval of new drugs[3].

Opportunities

The increasing focus on biologics and biosimilars presents opportunities for the bethanechol market. Strategic partnerships between pharmaceutical companies and Contract Research Organizations (CROs) can enhance clinical trial efficiency and outcomes, further driving market growth[3].

Conclusion

Urecholine, or bethanechol chloride, remains a vital drug in the management of urinary retention and related conditions. With a projected market size of $3.048 billion by 2030, the bethanechol market is poised for significant growth. This growth will be driven by increasing demand for effective treatments, advancements in drug delivery systems, and favorable regulatory environments.

Key Takeaways

  • Established Efficacy: Urecholine has a long history of efficacy in treating urinary retention.
  • Market Growth: The global bethanechol market is projected to grow to $3.048 billion by 2030.
  • Key Players: Major pharmaceutical companies are driving innovation and market growth.
  • Regional Focus: The Asia Pacific region is a key growth area due to its favorable regulatory environment and large treatment population.
  • Challenges and Opportunities: The market faces challenges but also has opportunities for growth through innovation and strategic partnerships.

FAQs

What is Urecholine used for?

Urecholine (bethanechol chloride) is used for the treatment of acute postoperative and postpartum nonobstructive urinary retention and neurogenic atony of the urinary bladder[5].

What is the projected market size of bethanechol by 2030?

The global market for bethanechol is forecasted to reach $3.048 billion by 2030[2].

Who are the key players in the bethanechol market?

Key players include Amneal Pharm, Eci Pharms, Heritage Pharma, Lannett, Upsher Smith Labs, and Wockhardt, among others[2].

What are the main drivers of the bethanechol market growth?

The main drivers include increasing demand for effective treatments, advancements in drug delivery systems, and favorable regulatory environments[2][3].

What are the challenges facing the bethanechol market?

Challenges include the availability of alternative treatments and the shortage of skilled professionals in clinical trials[3].

How does the Asia Pacific region influence the bethanechol market?

The Asia Pacific region offers cost benefits, a large treatment population, and improving regulatory environments, making it a significant growth area for the bethanechol market[3].

Sources

  1. POUT Trial: Final Results of the POUT Trial - ASCO Publications[1].
  2. Bethanechol Market Report: Bethanechol - Market, Report Size, Worth, Revenue, Growth[2].
  3. Clinical Trials Market: Clinical Trials Market Size, Share, Trends and Revenue Forecast[3].
  4. Bethanechol Survey: Bethanechol Remains the Preferred Drug in Suspected Underactive Bladder[4].
  5. Urecholine Package Insert: Urecholine: Package Insert / Prescribing Information - Drugs.com[5].

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