Treats overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and…. Sold as Gemtesa. Every FDA application for this active ingredient.
As of Nov 14, 2026, FDA lists 1 application for Vibegron (sold as Gemtesa), first approved Dec 23, 2020, with 1 new use approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Gemtesa | Part D | $1.21B | +28% | 393,611 |
| Efficacy of Mirabegron for Treatment of Non-monosymptomatic Nocturnal Enuresis in ChildrenTreatment of Non-monosymptomatic Nocturnal Enuresis · Menoufia University | Phase 3 | Active, not recruiting | Feb 9, 2026 |
| Vibegron for ENergy Thinking and Resilience in AgingObesity · Wake Forest University Health Sciences | Phase 3 | Recruiting | May 23, 2025 |
| Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary IncontinenceUrgency Urinary Incontinence · Women and Infants Hospital of Rhode Island | Phase 4 | Active, not recruiting | Apr 10, 2023 |
| Open-label, Long-term Safety, Efficacy, and Pharmacokinetics Study of Vibegron in Pediatric Subjects 2 Years to < 18 Years of Age With NDO and on CICNeurogenic Detrusor Overactivity · Urovant Sciences GmbH | Phase 2 / Phase 3 | Recruiting | Aug 8, 2022 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Dec 23, 2020 | GemtesaNDA 213006 · New molecular entity | Sumitomo Pharma Am | 2 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
