Last reviewed · How we verify
VIBEGRON
At a glance
| Generic name | VIBEGRON |
|---|---|
| Drug class | beta3-Adrenergic Agonist [EPC] |
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2018 |
Approved indications
Common side effects
- Headache
- Urinary tract infection
- Nasopharyngitis
- Diarrhea
- Nausea
- Upper respiratory tract infection
- Bronchitis
- Dry mouth
- Constipation
- Residual urine volume increased
- Hot flush
Serious adverse events
- Urinary retention
- Angioedema of the face and larynx
- Hypersensitivity reactions (urticaria, pruritus, rash, drug eruption)
- Eczema
Key clinical trials
- Vibegron for ENergy Thinking and Resilience in Aging (PHASE3)
- Role of Combination Therapy in Women With Refractory Overactive Bladder (NA)
- Efficacy of Mirabegron for Treatment of Non-monosymptomatic Nocturnal Enuresis in Children (PHASE3)
- Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence (PHASE4)
- Composur: Study to Understand the Performance of Vibegron in Participants with Overactive Bladder (OAB)
- Extension Study of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (PHASE3)
- Study to Evaluate the Efficacy, Safety and Tolerability of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH) (PHASE3)
- A Study of Vibegron in Pediatric Participants 2 Years to Less Than (<) 18 Years of Age With NDO and on CIC (PHASE2, PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- VIBEGRON CI brief — competitive landscape report
- VIBEGRON updates RSS · CI watch RSS