NDAORALTABLET
Approved
Dec 2020
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
4
Data completeness
7/8 — Comprehensive
GEMTESA (vibegron) by Sumitomo Dainippon Pharma is adrenergic beta3-agonists [moa]. Approved for overactive bladder. First approved in 2020.
Drug data last refreshed 23h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
GEMTESA (vibegron) is an oral tablet beta3-adrenergic agonist approved by the FDA on December 23, 2020, for the treatment of overactive bladder. It represents a novel mechanism of action distinct from anticholinergics, working through beta3-adrenergic receptor stimulation to relax detrusor muscle. The drug is currently in its peak lifecycle stage, indicating strong market penetration and established clinical use.
$0.5BPart D
16.2 years to LOEMechanism of Action
Adrenergic beta3-Agonists
Pharmacologic Class:
beta3-Adrenergic Agonist
Indications (1)
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.