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Last Updated: July 12, 2025

CLINICAL TRIALS PROFILE FOR MYRBETRIQ


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All Clinical Trials for Myrbetriq

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00410514 ↗ A Study of Mirabegron (YM178) in Men With Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO) Completed Astellas Pharma Inc Phase 2 2006-12-01 This study examined the safety, tolerability, and efficacy of mirabegron (YM178) compared to placebo.
NCT00688688 ↗ Study to Test the Long Term Safety and Efficacy of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder Completed Astellas Pharma Inc Phase 3 2008-04-25 The study is intended to test the safety, tolerability, efficacy of two doses of long term once daily (qd) treatment of Mirabegron in patients with symptoms of overactive bladder and secondly to compare these with active comparator.
NCT00689104 ↗ Study to Assess the Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder Completed Astellas Pharma Inc Phase 3 2008-04-28 The study is intended to test efficacy, safety and tolerability of two doses of Mirabegron against placebo and compare the efficacy and safety with active comparator in patients with symptoms of overactive bladder.
NCT01340027 ↗ A Study to Evaluate the Efficacy, Safety and Tolerability of Mirabegron and Solifenacin Succinate Alone and in Combination for the Treatment of Overactive Bladder Completed Astellas Pharma Europe B.V. Phase 2 2011-03-29 The purpose of this study is to examine how well two medicines in combination (solifenacin succinate and mirabegron) work in the treatment of bladder problems over a 12-week period.
NCT01638000 ↗ A Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Patients With Overactive Bladder Who Were Previously Treated With Another Medicine But Were Not Satisfied With That Treatment. Completed Astellas Pharma Europe Ltd. Phase 3 2012-06-12 The purpose of the study was to assess the efficacy, safety and tolerability of mirabegron 50 mg versus (vs) solifenacin 5 mg in the treatment of patients with OAB who were dissatisfied with their treatment due to lack of efficacy.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Myrbetriq

Condition Name

Condition Name for Myrbetriq
Intervention Trials
Overactive Bladder 15
Urinary Bladder, Overactive 6
Urologic Diseases 4
Neurogenic Detrusor Overactivity 4
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Condition MeSH

Condition MeSH for Myrbetriq
Intervention Trials
Urinary Bladder, Overactive 28
Urinary Incontinence 6
Lower Urinary Tract Symptoms 6
Urologic Diseases 6
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Clinical Trial Locations for Myrbetriq

Trials by Country

Trials by Country for Myrbetriq
Location Trials
United States 251
Canada 47
Germany 16
Poland 12
Hungary 12
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Trials by US State

Trials by US State for Myrbetriq
Location Trials
California 13
Maryland 11
New York 10
Florida 10
Texas 10
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Clinical Trial Progress for Myrbetriq

Clinical Trial Phase

Clinical Trial Phase for Myrbetriq
Clinical Trial Phase Trials
Phase 4 12
Phase 3 12
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Myrbetriq
Clinical Trial Phase Trials
Completed 31
Not yet recruiting 7
Recruiting 6
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Clinical Trial Sponsors for Myrbetriq

Sponsor Name

Sponsor Name for Myrbetriq
Sponsor Trials
Astellas Pharma Europe B.V. 8
Astellas Pharma Inc 7
Astellas Pharma Global Development, Inc. 6
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Sponsor Type

Sponsor Type for Myrbetriq
Sponsor Trials
Other 37
Industry 31
NIH 3
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MYRBETRIQ (Mirabegron): Clinical Trials Update, Market Analysis, and Projections

Last updated: January 1, 2025

Introduction

MYRBETRIQ, known generically as mirabegron, is a beta-3 adrenergic receptor agonist primarily used for the treatment of overactive bladder (OAB) symptoms, including urgency, urgency incontinence, and urinary frequency. Here, we will delve into the recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

Efficacy and Safety in OAB

MYRBETRIQ has been extensively evaluated in several clinical trials to assess its efficacy and safety in patients with OAB. Three Phase III studies (Studies 178-CL-046, -047, and -074) involved over 3,000 patients and demonstrated statistically significant and clinically relevant improvements in OAB symptoms compared to placebo. These studies showed that MYRBETRIQ, at doses of 25 mg and 50 mg once daily, effectively reduced the frequency of micturitions, urgency, and incontinence episodes[3][4].

Long-Term Safety

A 1-year, randomized, active-controlled safety study further reinforced the safety profile of MYRBETRIQ. This study found no significant differences in safety or effectiveness between patients under 65 years and those 65 years or older. The most common adverse reactions reported were hypertension, nasopharyngitis, urinary tract infections, and headache, which were generally mild and did not differ significantly from the placebo group[4].

Cardiovascular Trials

Recently, the Beta3-LVH trial investigated the use of mirabegron in patients with left ventricular hypertrophy (LVH) to assess its potential in preventing the progression of structural heart disease. Although the trial showed that mirabegron was safe in patients with cardiovascular risk factors, it failed to prevent the progression of structural heart disease. This outcome was attributed to the low expression of beta-3 receptors in the hearts of the study population and the use of a standard therapeutic dose[1].

Market Analysis

Current Market Landscape

The global overactive bladder drug market, valued at $2.2 billion in 2020, is projected to grow at a compound annual growth rate (CAGR) of more than 2% from 2021 to 2030. MYRBETRIQ currently dominates the market, accounting for over 50% of global sales in 2020. The US market is the largest, contributing more than 45% of global sales due to the high prevalence of OAB and the high cost of drug therapy in this region[2][5].

Market Challenges

Despite its dominance, the OAB market faces several challenges. Patent expirations for key products, including MYRBETRIQ, VESIcare, and Toviaz, are expected to lead to generic sales erosion in the early-to-mid forecast period. Additionally, social stigma and lack of awareness about OAB among patients and healthcare professionals result in low diagnosis and treatment rates. Poor persistence and adherence to drug therapy further hinder market growth[2][5].

Future Projections

Market Growth

The market is expected to experience a decline in the early-to-mid forecast period due to patent expiries but will see a boost from the launch of pipeline products in the mid-to-late forecast period. By 2030, the global OAB market is projected to reach $2.8 billion, driven by an aging population and the increasing prevalence of OAB[2][5].

Pipeline Products

The scarcity of late-stage pipeline products is a significant barrier to immediate market growth. However, the potential launch of new therapies, including gene therapies, could revitalize the market. For instance, Urovant Sciences is working on the first gene therapy for OAB, which could offer new treatment options and stimulate market growth[2].

Key Takeaways

  • Clinical Efficacy: MYRBETRIQ has demonstrated significant efficacy in reducing OAB symptoms in multiple clinical trials.
  • Safety Profile: The drug has a favorable safety profile, with minimal adverse events, and is safe for use in patients with cardiovascular risk factors.
  • Market Dominance: MYRBETRIQ is the leading OAB therapy, accounting for over 50% of global sales.
  • Market Challenges: Patent expirations, social stigma, and poor adherence to therapy are major challenges facing the OAB market.
  • Future Growth: The market is expected to grow, driven by an aging population and the launch of new pipeline products.

FAQs

What is MYRBETRIQ used for?

MYRBETRIQ is used for the treatment of overactive bladder (OAB) symptoms, including urgency, urgency incontinence, and urinary frequency.

What are the common adverse reactions associated with MYRBETRIQ?

Common adverse reactions include hypertension, nasopharyngitis, urinary tract infections, and headache.

How does MYRBETRIQ compare to other OAB treatments?

MYRBETRIQ is a beta-3 adrenergic receptor agonist, which distinguishes it from antimuscarinic drugs. It has shown comparable efficacy to other treatments like tolterodine ER in clinical trials.

What are the market projections for the OAB drug market?

The global OAB market is projected to grow at a CAGR of more than 2% from 2021 to 2030, reaching $2.8 billion by 2030.

Why is the OAB market growth hindered despite high prevalence?

The market growth is hindered by factors such as patent expirations, social stigma, lack of awareness, and poor adherence to therapy.

Sources

  1. European Society of Cardiology. Mirabegron is safe but fails to prevent remodelling in patients with mild heart disease. Press Release, November 7, 2022.
  2. ResearchAndMarkets.com. Global Overactive Bladder Drug Forecast and Market Analysis to 2030. Business Wire, January 31, 2022.
  3. Health Canada. Summary Basis of Decision for Myrbetriq.
  4. Myrbetriqhcp.com. PILLAR Safety | MYRBETRIQ® (mirabegron ER tablets).
  5. GlobalData. Overactive Bladder: Global Drug Forecast and Market Analysis to 2030. December 14, 2021.

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