Vibegron is a beta3-adrenergic agonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults, among other approved uses. It is available as tablets for oral use. MedsAcross supplies Vibegron for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
GEMTESA is a beta-3 adrenergic agonist indicated for the treatment of: overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults. overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adult males on pharmacological therapy for benign prostatic hyperplasia (BPH).
Source: US FDA prescribing information
Vibegron is a selective human beta-3 adrenergic receptor agonist. Activation of the beta-3 adrenergic receptor increases bladder capacity by relaxing the detrusor smooth muscle during bladder filling.
Source: US FDA prescribing information
The recommended dose is one 75 mg tablet orally once daily. Swallow tablet whole with water. Tablet may be crushed and mixed with applesauce.
Source: US FDA prescribing information
GEMTESA is contraindicated in patients with known hypersensitivity to vibegron or any components of GEMTESA. Hypersensitivity reactions, such as angioedema, have occurred. Do not use if prior hypersensitivity reaction to vibegron or any components of the product.
Source: US FDA prescribing information
Urinary Retention: Monitor for urinary retention, especially in patients with bladder outlet obstruction and also in patients taking muscarinic antagonist medications for OAB, in whom the risk of urinary retention may be greater. If urinary retention develops, discontinue GEMTESA. Angioedema: Angioedema of the face and/or larynx has been reported with GEMTESA.
Source: US FDA prescribing information
The following clinically significant adverse reaction is described elsewhere in the labeling: Urinary retention Most common adverse reactions (≥2%) reported with GEMTESA were headache, urinary tract infection, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection.
Source: US FDA prescribing information
Concomitant use of GEMTESA increases digoxin maximal concentrations (C max ) and systemic exposure as assessed by area under the concentration-time curve (AUC). Serum digoxin concentrations should be monitored before initiating and during therapy with GEMTESA and used for titration of the digoxin dose to obtain the desired clinical effect. Continue monitoring digoxin concentrations upon discontinuation of GEMTESA and adjust digoxin dose as needed. Digoxin: Measure serum digoxin concentrations before initiating GEMTESA. Monitor serum digoxin concentrations to titrate digoxin dose to desired clinical effect.
Source: US FDA prescribing information
Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Vibegron, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Gemtesa 75 mg tabletOral | Sumitomo Pharma | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 1 presentations of Vibegron and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Vibegron, including Gemtesa.
Yes. The US FDA first approved Vibegron on 23 December 2020, according to Drugs@FDA.
Yes. Vibegron has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Vibegron is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Vibegron is classified under ATC code G04BD15 (Vibegron).
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