NDAORALTABLET
Approved
Dec 2020
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
4
Data completeness
6/8 — Strong
GEMTESA (vibegron) by Sumitomo Dainippon Pharma is adrenergic beta3-agonists [moa]. First approved in 2020.
Drug data last refreshed 22m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
GEMTESA (vibegron) is an oral beta-3 adrenergic agonist approved in December 2020 for overactive bladder (OAB). It represents a novel mechanism within the OAB market, offering an alternative to anticholinergic agents. The drug works by activating beta-3 receptors on bladder smooth muscle to increase storage capacity and reduce urinary urgency.
$508MPart D
Peak15.8 years to LOEProduct is at peak commercial maturity with substantial Medicare utilization ($508M Part D spend in 2023), suggesting a stable, well-resourced brand team managing a mature franchise.
Mechanism of Action
Adrenergic beta3-Agonists
Pharmacologic Class:
beta3-Adrenergic Agonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (4)
A Single-Dose Study of the Pharmacokinetics of Vibegron (MK-4618) in Adults With Hepatic Insufficiency (MK-4618-013)
Started Jan 2013
16 enrolled
Overactive Bladder
A Single Dose Study of the Pharmacokinetics of Vibegron (MK-4618) in Participants With Renal Insufficiency (MK-4618-014)
Started Jul 2012
32 enrolled
Overactive Bladder
A Study of the Pharmacokinetics and Pharmacodynamics of Vibegron (MK-4618) in Women With Overactive Bladder (MK-4618-004)
Started Feb 2012
4 enrolled
Overactive BladderOveractive Urinary Bladder
A Study of the Efficacy and Safety of Vibegron (MK-4618) in Participants With Overactive Bladder (OAB) (MK-4618-008)
Started Mar 2011
1,395 enrolled
Urinary Bladder, Overactive
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.