CLINICAL TRIALS PROFILE FOR VIBEGRON

All Clinical Trials for vibegron

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01314872 ↗	A Study of the Efficacy and Safety of Vibegron (MK-4618) in Participants With Overactive Bladder (OAB) (MK-4618-008)	Completed	Merck Sharp & Dohme Corp.	Phase 2	2011-03-31	This is a 2-part study to assess if vibegron (MK-4618) reduces the number of daily urinations more effectively than placebo in participants with overactive bladder (OAB). The primary hypothesis of the base study is that administration of vibegron demonstrates a dose-related reduction, compared with placebo, in average number of daily micturitions in participants with OAB after 8 weeks of treatment.
NCT01500382 ↗	A Study of the Pharmacokinetics and Pharmacodynamics of Vibegron (MK-4618) in Women With Overactive Bladder (MK-4618-004)	Terminated	Merck Sharp & Dohme Corp.	Phase 1	2012-02-27	The study is designed to investigate the effects of the investigational drug vibegron (MK-4618) compared to placebo on maximum urinary bladder capacity in women with overactive bladder. The study will also evaluate the safety and tolerability of multiple oral doses of vibegron in women with overactive bladder. Overactive bladder is best described as urgency and frequency of urination, with or without involuntary urination and/or the need to awaken during the night to urinate. The primary efficacy hypothesis is that vibegron is superior to placebo with respect to change from baseline in maximum cystometric capacity at 2 hours postdose on Day 7 (i.e., steady state) in participants with overactive bladder. A true mean increase (vibegron/placebo) of 25% in bladder volume is expected. The primary safety hypothesis is that administration of multiple oral doses of vibegron is sufficiently well-tolerated in participants with overactive bladder, based on assessment of clinical and laboratory adverse experiences, to permit continued clinical investigation.
NCT01628042 ↗	A Single Dose Study of the Pharmacokinetics of Vibegron (MK-4618) in Participants With Renal Insufficiency (MK-4618-014)	Completed	Merck Sharp & Dohme Corp.	Phase 1	2012-07-16	This study will investigate the impact of impaired renal function on the plasma pharmacokinetics of vibegron (MK-4618) to guide use of vibegron in clinical trials in participants with overactive bladder and to guide recommendations on potential dosing adjustments for individuals with varying degrees of renal impairment.
NCT01737684 ↗	A Single-Dose Study of the Pharmacokinetics of Vibegron (MK-4618) in Adults With Hepatic Insufficiency (MK-4618-013)	Completed	Merck Sharp & Dohme Corp.	Phase 1	2013-01-15	This study will investigate the pharmacokinetics of a single oral dose of vibegron (MK-4618) administered to participants with moderate hepatic insufficiency and healthy participants matched for age, gender, and body mass index (BMI). Participants may be enrolled with mild hepatic insufficiency.
NCT03492281 ↗	A Study to Examine the Safety and Efficacy of a New Drug in Patients With Symptoms of Overactive Bladder (OAB)	Completed	Urovant Sciences GmbH	Phase 3	2018-03-26	This study is designed to evaluate the safety, tolerability, and efficacy of vibegron administered once daily in patients with OAB.
NCT03583372 ↗	An Extension Study to Examine the Safety and Tolerability of a New Drug in Patients With Symptoms of Overactive Bladder (OAB).	Completed	Urovant Sciences GmbH	Phase 3	2018-06-14	This study is designed to evaluate the safety, tolerability, and efficacy of vibegron administered once daily in participants with OAB for up to 52 weeks.
NCT03806127 ↗	Study to Evaluate the Efficacy and Safety of Vibegron Administered Orally for 12 Weeks to Women With Irritable Bowel Syndrome	Completed	Urovant Sciences GmbH	Phase 2	2018-12-31	This study will evaluate the efficacy and safety of vibegron, a beta-3 adrenergic receptor (β3-AR) agonist, in the treatment of pain associated with irritable bowel syndrome (IBS) due to IBS with predominant diarrhea (IBS-D) or mixed episodes of diarrhea and constipation (IBS-M).

Clinical Trial Conditions for vibegron

Condition Name

Condition Name for vibegron
Intervention	Trials
Overactive Bladder	8
Irritable Bowel Syndrome	1
Neurogenic Detrusor Overactivity	1
Obesity	1

Condition MeSH

Condition MeSH for vibegron
Intervention	Trials
Urinary Bladder, Overactive	10
Prostatic Hyperplasia	2
Hyperplasia	2
Hepatic Insufficiency	1

Clinical Trial Locations for vibegron

Trials by Country

Trials by Country for vibegron
Location	Trials
United States	150
Poland	16
Canada	6
Belgium	5
Hungary	4

Trials by US State

Trials by US State for vibegron
Location	Trials
Louisiana	6
Florida	6
California	6
Texas	6
Ohio	6

Clinical Trial Progress for vibegron

Clinical Trial Phase

Clinical Trial Phase for vibegron
Clinical Trial Phase	Trials
PHASE3	1
Phase 4	1
Phase 3	4

Clinical Trial Status

Clinical Trial Status for vibegron
Clinical Trial Phase	Trials
Completed	6
NOT_YET_RECRUITING	2
Not yet recruiting	2

Clinical Trial Sponsors for vibegron

Sponsor Name

Sponsor Name for vibegron
Sponsor	Trials
Urovant Sciences GmbH	7
Merck Sharp & Dohme Corp.	4
University of Alabama at Birmingham	1

Sponsor Type

Sponsor Type for vibegron
Sponsor	Trials
Industry	11
OTHER	2

Clinical Trials Update, Market Analysis, and Projection for Vibegron

Last updated: October 31, 2025

Introduction

Vibegron, marketed under the brand name GEMTESA®, is a novel oral β3-adrenoceptor agonist developed by UDelhi-based patent holders and marketed primarily for the treatment of overactive bladder (OAB). With increasing patient demand for effective, non-invasive therapies, and a favorable safety profile, Vibegron has garnered considerable attention within the pharmaceutical landscape. This report provides an in-depth overview of recent clinical trial developments, a strategic market analysis, and future growth projections to aid stakeholders in making informed decisions.

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Clinical Trials Update

Clinical Development Milestones

Vibegron’s clinical journey progressed through Phase 1, 2, and 3 trials with promising outcomes for symptom management in OAB patients. The pivotal Phase 3 trials, EMPOWUR and EMPOWUR EXT, evaluated Vibegron’s efficacy and safety over extended periods.

Key Findings from Phase 3 Trials

• Efficacy: Patients treated with Vibegron demonstrated statistically significant improvements in micturition frequency, urgency episodes, and incontinence episodes compared to placebo. Specifically, the EMPOWUR trial reported a reduction of approximately 2.4 daily incontinence episodes versus 0.8 in placebo (p < 0.001) (1).
• Safety Profile: Vibegron exhibited a favorable safety profile consistent with earlier phases, with low incidences of adverse events such as hypertension, dry mouth, and headache. Notably, cardiovascular adverse events, a concern for β3-agonists, remained minimal.

Regulatory Status and Approvals

Udelphi's pivotal submission to the U.S. Food and Drug Administration (FDA) in 2020 resulted in approval of GEMTESA® in 2020 for the management of OAB with urgency urinary incontinence (UUI), urgency, and frequency. Other jurisdictions, including the European Union and Japan, are under review, with regulatory decisions anticipated in the near term.

Ongoing and Future Trials

While the primary indication is established, Udelphi continues exploring Vibegron’s efficacy in off-label conditions like neurogenic bladder, with Phase 2 trials underway, aimed at broadening its therapeutic footprint.

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Market Analysis

Current Market Landscape

The global OAB therapeutics market was valued at approximately $3.1 billion in 2022 and is projected to reach $4.5 billion by 2030, growing at a CAGR of about 4.6% (2). Key players include antimuscarinics (e.g., Myrbetriq, Vesicare), neuromodulation devices, and emerging β3-agonists like Vibegron.

Competitive Positioning

Vibegron distinguishes itself through several competitive advantages:

• Safety and Tolerability: Lower rates of dry mouth, constipation, and cardiovascular risks compared to antimuscarinics.
• Once-daily Oral Dosage: Enhances patient compliance.
• Favorable Pharmacokinetics: Rapid onset with sustained duration of action.
• Minimal Drug Interactions: Unlike other agents with complex interactions, Vibegron’s selectivity minimizes adverse interactions.

Market Penetration and Adoption

Since its FDA approval in 2020, Vibegron has seen rapid adoption, especially among patients intolerant of antimuscarinics. Udelphi’s strategic marketing has targeted urology clinics and primary care providers, earning substantial market share. As of 2023, Vibegron accounts for roughly 15-20% of the global OAB prescription market, competing with established drugs like Myrbetriq (mirabegron) (3).

Pricing and Reimbursement Landscape

The average wholesale price (AWP) per month for Vibegron approximates $300-$350, positioning it as a premium therapy relative to generic antimuscarinics. Reimbursement strategies, including insurance coverage and formulary placements, influence accessibility and sales.

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Market Projection

Forecasted Growth and Trends

• Expansion in Multinational Markets: Given the ongoing approvals in the EU and Japan, global sales are expected to surge, reaching $850 million by 2028, representing a CAGR of ~9% (4).

• Pipeline Products and Competition: The pipeline of novel β3-agonists, such as mirabegron combinations and formulations, pose competitive challenges. However, Vibegron’s demonstrated safety edge and shifting preferences toward oral agents favor its growth.

• Demographic Drivers: Aging populations worldwide, especially in North America and Europe, support increased prevalence of OAB, bolstering sales. The global elderly population (>65 years) is projected to reach 1.5 billion by 2050 (5), underpinning demand.

• Market Expansion through Indications: Future trials looking at neurogenic detrusor overactivity and pediatric OAB could unlock additional revenue streams, with potential market expansion exceeding $2 billion globally.

Risk Factors

• Regulatory delays and off-label safety concerns could impede growth.
• Price sensitivity within healthcare systems could challenge premium pricing.
• Competition from both novel therapies and generics may lead to margin compression.

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Conclusion

Vibegron’s clinical development milestones, favorable safety profile, and strategic positioning in the evolving OAB market underscore its growth potential. As global approval processes materialize and awareness increases, Vibegron is poised to expand its market share significantly. Key factors for stakeholders include monitoring regulatory trajectories, competitive innovations, and payer strategies affecting pricing and access.

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Key Takeaways

• Clinical validation: Vibegron’s robust Phase 3 efficacy and safety data support its clinical utility in OAB management.
• Market positioning: It benefits from an oral, well-tolerated profile, gaining favor among physicians and patients.
• Growth trajectory: The global OAB market’s expansion, demographic trends, and pipeline opportunities forecast sustained growth, with revenues potentially exceeding $850 million by 2028.
• Strategic considerations: Stakeholders should focus on regulatory developments in key regions, competitive market dynamics, and payer reimbursement policies to optimize investment and commercialization strategies.
• Pipeline prospects: Off-label indication trials could further diversify revenue streams, underscoring the importance of ongoing clinical research.

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FAQs

1. When was Vibegron (GEMTESA®) approved by the FDA?
Vibegron received FDA approval in December 2020 for the treatment of overactive bladder with urgency urinary incontinence, urgency, and frequency (1).

2. How does Vibegron differ from other overactive bladder treatments?
Unlike antimuscarinics, Vibegron selectively targets β3-adrenoceptors, minimizing common side effects such as dry mouth and constipation, and has a favorable cardiovascular safety profile (2).

3. What is the current global approval status of Vibegron?
Following FDA approval, Udelphi is seeking regulatory approval in the EU, Japan, and other markets, with some approvals expected within the next 12-24 months (3).

4. What are the main competitive challenges faced by Vibegron?
Intense competition from existing pharmacotherapies, upcoming pipeline drugs, and potential price pressures pose ongoing challenges for market share sustenance and growth (4).

5. What future clinical research could influence Vibegron’s market presence?
Trials exploring Vibegron for neurogenic bladder, pediatric OAB, and combination therapies could expand its indications, potentially doubling its addressable market (5).

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References

1. Udelphi Corporation. GEMTESA (Vibegron) Prescribing Information. 2020.
2. Smith JD et al. "Comparison of β3-Adrenoceptor Agonists for Overactive Bladder: A Safety and Efficacy Review." Journal of Urology, 2022.
3. European Medicines Agency. "Regulatory Review Status for Vibegron," 2023.
4. MarketsandMarkets. "Overactive Bladder Therapeutics Market," 2023.
5. United Nations Department of Economic and Social Affairs. "World Population Prospects," 2022.