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Beta-3 Adrenergic Agonist

Vibegron for Overactive Bladder

Phase 3
Waitlist Available
Research Sponsored by Urovant Sciences GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 52
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial will test the long-term safety of vibegron for up to a year in men with overactive bladder symptoms who are also being treated for an enlarged prostate. Vibegron helps relax bladder muscles, making it easier to control urination.

Eligible Conditions
  • Overactive Bladder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
Change From Baseline in Heart Rate
Number of Participants With Any Serious Adverse Event, and Treatment Emergent Adverse Event (>5%)
+4 more
Secondary study objectives
Change From Baseline at Week 52 in the Average Number of Micturition Episodes Per Day
Change From Baseline at Week 52 in the Average Number of Nocturia Episodes Per Night
Change From Baseline at Week 52 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per Day in Participants With Incontinence
+3 more

Side effects data

From 2022 Phase 3 trial • 276 Patients • NCT04103450
2%
COVID-19
1%
Cervical vertebral fracture
1%
Atrial fibrillation
1%
Non-cardiac chest pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
28-Week Vibegron Group
52-Week Vibegron Group

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: VibegronExperimental Treatment1 Intervention
Participants will receive 75 milligrams (mg) vibegron orally once daily (QD).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vibegron
2018
Completed Phase 3
~3520

Find a Location

Who is running the clinical trial?

Urovant Sciences GmbHLead Sponsor
10 Previous Clinical Trials
3,988 Total Patients Enrolled
Study DirectorStudy DirectorUrovant Sciences
1,276 Previous Clinical Trials
499,001 Total Patients Enrolled
Rachael Jankowich, RN, MSNStudy DirectorUrovant Sciences
1 Previous Clinical Trials
1,105 Total Patients Enrolled
~45 spots leftby Nov 2025
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