CLINICAL TRIALS PROFILE FOR MYRBETRIQ

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.
NCT01908829 ↗	A Trial Comparing Combination Treatment (Solifenacin Plus Mirabegron) With One Treatment Alone (Solifenacin)	Completed	Astellas Pharma Europe Ltd.	Phase 3	2013-07-10	The purpose of this study was to see if adding a new type of medication recently approved to treat overactive bladder (mirabegron) to an antimuscarinic treatment (solifenacin) would be more effective in controlling incontinence than when using the antimuscarinic treatment alone.

Clinical Trial Conditions for Myrbetriq

Condition Name

Condition Name for Myrbetriq
Intervention	Trials
Overactive Bladder	15
Urinary Bladder, Overactive	6
Urologic Diseases	4
Urinary Bladder Diseases	4

Condition MeSH

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

Clinical Trial Locations for Myrbetriq

Trials by Country

Trials by Country for Myrbetriq
Location	Trials
United States	252
Canada	47
Germany	16
Poland	12
Hungary	12

Trials by US State

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

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

Clinical Trial Status

Clinical Trial Status for Myrbetriq
Clinical Trial Phase	Trials
Completed	32
Not yet recruiting	7
Recruiting	6

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

Sponsor Type

Sponsor Type for Myrbetriq
Sponsor	Trials
Other	39
Industry	31
NIH	3

Myrbetriq Market Analysis and Financial Projection

Last updated: February 8, 2026

What is the current status of clinical trials for MYRBETRIQ?

MYRBETRIQ (mirabegron) is approved for treating overactive bladder (OAB). Its development plateaued after initial approval, with ongoing Phase 4 studies monitoring long-term safety and efficacy. No active Phase 1-3 trials are currently listed in ClinicalTrials.gov as of February 2023, indicating focus has shifted from primary development to post-market surveillance and indication expansion.

What indications is MYRBETRIQ being explored for beyond its approved use?

Research has explored MYRBETRIQ for conditions such as:

• Urinary incontinence in spinal cord injury patients.
• Neurogenic bladder dysfunction.
• Chronic cough in some small trials, but these remain in early phases or exploratory stages without significant progression.

Most ongoing trials are observational or long-term safety studies rather than Phase 2 or 3 efficacy trials outside the approved indication.

How does MYRBETRIQ compare to competitors in the market?

Drug	Approval Date	Indications	Market Share (2022)	Key Advantages
MYRBETRIQ	2012 (FDA)	Overactive bladder	~40%	Once-daily oral, fewer anticholinergic side effects
Imipramine	Off-label	OAB, nocturia	Not licensed	Well-known, generic, but side effect profile
Oxybutynin	Approved 1978	Overactive bladder	~20%	Generic, affordable
Solifenacin	Approved 2008	OAB, urinary incontinence	Smaller share	Selectivity for M3 receptors, fewer side effects

MYRBETRIQ's main advantage over anticholinergics:

• No anticholinergic effects such as dry mouth, constipation, or cognitive decline, making it preferable for elderly patients.

What are the market projections for MYRBETRIQ?

The global overactive bladder market was valued at approximately $4.2 billion in 2022, projected to reach $6 billion by 2027, growing at a CAGR of 7%. MYRBETRIQ, capturing around 40% of the market, is expected to maintain a leading position given indications for patient populations intolerant to anticholinergics.

Several factors influence future growth:

• Expansion into new indications: Neurogenic bladder, incontinence in stroke patients.
• Geographical expansion: Regulatory approvals in Europe, Asia-Pacific, Latin America.
• Patent status: The original patent expired in 2015 (US), but formulations and new delivery methods (extended-release) may be under patent protection until 2030.

Direct competing drugs, such as solifenacin and darifenacin, are expected to see steady sales, but MYRBETRIQ's favorable side effect profile supports continued market share.

What regulatory or patent developments could impact MYRBETRIQ's market?

• The expiry of patent protection in 2015 opened the market for generics, leading to price pressures. Still, reformulations or combination therapies may sustain profitability.
• Clinical trials for new indications may lead to label expansions, increasing market potential.
• Regulatory approvals in emerging markets could provide growth avenues, especially where overactive bladder prevalence is rising.

What are the key challenges facing MYRBETRIQ's market prospects?

• Competition from well-established anticholinergics with low cost.
• Low awareness or acceptance in markets where traditional therapies dominate.
• Long-term safety data, although positive, may limit rapid expansion into aggressive new indications.
• Potential generic entry post-patent expiry, unless new formulations or delivery patents are secured.

Summary of financial and market outlook

MYRBETRIQ's sales in 2022 totaled approximately $750 million globally. Sales are expected to grow steadily, driven by increased coverage of new indications and geographic expansion, reaching over $1 billion by 2026 if the company invests in regulatory approvals and market penetration.

Key Takeaways

• MYRBETRIQ remains the leading drug for OAB with a strong safety profile.
• Clinical trials are primarily ongoing for safety monitoring rather than new indications.
• Market growth hinges on indication expansion and geographical expansion.
• Patent expirations pose a threat but may be mitigated by reformulations.
• Competitive pressure persists from cheaper generics and alternative therapies.

FAQs

1. Are there any ongoing Phase 3 trials for MYRBETRIQ?
No active Phase 3 trials for new indications are listed as of February 2023. The focus is on post-market safety studies.

2. Will MYRBETRIQ be approved for neurogenic bladder?
Current data suggest ongoing exploration, but no regulatory approval has been granted yet. Future approvals depend on trial results.

3. How does MYRBETRIQ compare in cost to alternatives?
MYRBETRIQ's pricing is higher than generic anticholinergics but lower than some newer agents. Cost-effectiveness favors MYRBETRIQ for patients intolerant to anticholinergics.

4. What markets are expected to see the most growth for MYRBETRIQ?
Europe and Asia-Pacific present significant potential, contingent on regulatory approval and medical adoption.

5. What patent protections remain for MYRBETRIQ?
Original formulation patents expired in 2015 in the US, but secondary patents or reformulations could extend exclusivity until 2030.

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Sources:
[1] ClinicalTrials.gov, FDA filings, market research reports (2022-2023).