GEMTESA (vibegron)
GEMTESA is indicated for the treatment of Overactive Bladder; Benign Prostatic Hyperplasia.
How GEMTESA Works
Vibegron acts as a selective human beta-3 adrenergic receptor agonist. By activating these receptors, the medication induces relaxation of the detrusor smooth muscle during the bladder-filling phase. This mechanism increases functional bladder capacity, thereby reducing the clinical symptoms of urinary frequency and urgency.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2020-12-23
- Patent Cliff
- 2042
- Routes
- ORAL
- Dosage Forms
- TABLET
GEMTESA Approval History
What GEMTESA Treats
2 indicationsGEMTESA is approved for 2 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Overactive Bladder
- Benign Prostatic Hyperplasia
GEMTESA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to GEMTESA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
10 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06987383 VENTURA | Brinkley.Vibegron R21AG091075 | Ph 3 | not yet recruiting | Vibegron for ENergy Thinking and Resilience in Aging |
| NCT04103450 results posted | URO-901-3006 2018-003136-72 | Ph 3 | completed | Extension Study of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia |
| NCT03902080 results posted | URO-901-3005 2018-003135-30 | Ph 3 | completed | 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) |
| NCT05491525 KANGUROO | URO-901-3007 | Ph 2, Ph 3 | recruiting | A Study of Vibegron in Pediatric Participants 2 Years to Less Than (<) 18 Years of Age With NDO and on CIC |
| NCT03806127 results posted | URO-901-2001 | Ph 2 | completed | Study to Evaluate the Efficacy and Safety of Vibegron Administered Orally for 12 Weeks to Women With Irritable Bowel Syndrome |
| NCT03583372 Empowur results posted | RVT-901-3004 2017-003294-33 | Ph 3 | completed | An Extension Study to Examine the Safety and Tolerability of a New Drug in Patients With Symptoms of Overactive Bladder (OAB). |
| NCT03492281 Empowur results posted | RVT-901-3003 2017-003293-14 | Ph 3 | completed | A Study to Examine the Safety and Efficacy of a New Drug in Patients With Symptoms of Overactive Bladder (OAB) |
| NCT01314872 results posted | 4618-008 132241, 2010-022121-15 | Ph 2 | completed | A Study of the Efficacy and Safety of Vibegron (MK-4618) in Participants With Overactive Bladder (OAB) (MK-4618-008) |
| NCT01500382 results posted | 4618-004 | Ph 1 | terminated | A Study of the Pharmacokinetics and Pharmacodynamics of Vibegron (MK-4618) in Women With Overactive Bladder (MK-4618-004) |
| NCT01737684 results posted | 4618-013 | Ph 1 | completed | A Single-Dose Study of the Pharmacokinetics of Vibegron (MK-4618) in Adults With Hepatic Insufficiency (MK-4618-013) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
GEMTESA FDA Label Details
Indications & Usage
FDA Label (PDF)GEMTESA is indicated for the treatment of Overactive Bladder; Benign Prostatic Hyperplasia.
GEMTESA Patents & Exclusivity
Patents (5 active)
Exclusivity
Pro Intelligence Preview
Deep insights for GEMTESA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2042
- • 6 active patents
Trial Analysis
- • 10 total trials
- • Stage: Stable
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment